Background Core outcome measurement sets (COMS) enhance the consistency and comparability of outcome reporting in clinical research. However, their effectiveness depends on the selection of valid, reliable, and feasible measurement instruments. Core outcome sets (COS) and COMS have been developed for specific intensive care unit (ICU) patient subgroups. The aim of this study is to establish a standardised approach to outcome measurement and operationalisation for adults acutely admitted to the ICU who are participating in clinical trials and other clinical research.Methods This protocol describes the development of a COMS for adults acutely admitted to the ICU, the CoreMS-ICU, consisting of six core outcomes: survival, free of life support, free of delirium, out of hospital, health-related quality of life, and cognitive function. We will follow the Consensus-based Standards for the Selection of Health Measurement Instruments guideline and report according to the Core Outcome Set-STAndardised Protocol Items guideline. The development of the CoreMS-ICU will follow five predefined steps: (1) conceptual considerations for the six core outcomes; (2) systematic searches for outcome measurement instruments, including consideration of existing COMS; (3) quality assessment of relevant outcome measurement instruments; (4) consensus-based selection of outcome measurement instruments; and (5) recommendations and guidance on how to operationalise and report the measurement of the six core outcomes. We will involve research panels consisting of key stakeholders: patients, family members, healthcare professionals, and researchers in steps 1 and 4.Conclusions We aim to develop a COMS for adults acutely admitted to ICU patients to facilitate the consistent use of outcomes in trials and enhance the translation of research findings into clinical practice.
Life expectancy increases, leading to growth in an older population where frailty and comorbidities are more prevalent. Subsequent increased intensive care unit (ICU) treatment results in prolonged rehabilitation and post-discharge loss of physiological and intellectual functions, negatively influencing quality of life (QoL). This scoping review aims to identify existing research on assessment methods for frailty, QoL, and health-related outcomes for these ICU survivors. The review followed Joanna Briggs Institute guidelines for scoping reviews and reported using the PRISMA-P checklist. Systematic searches were conducted in Embase, Medline, PsycINFO, and CINAHL (2013 to 2023). Included studies were primary, peer-reviewed, or empirical studies written in English or Scandinavian, patients aged 70+, admitted to ICU more than 48 h, and inclusion of both frailty and QoL. A librarian qualified the search. Two reviewers independently screened articles and extracted data; a third reviewer resolved discrepancies. A total of 5,198 articles were identified. Nine met the eligibility criteria. Different tools assessed frailty and QoL. For frailty, Clinical Frailty Scale, Karnofsky Performance Status, Modified Katz Index of Activities of Daily Living, Groningen Frailty Indicator, CGA questionnaire, or Barthel Index were used. A combination of scales (SF-12, SF-36, EQ-5D, EQ-5D-5 L, or EQ-5D-3 L), questionnaires, or interviews (regarding residential and functional status and self-reported health-related QoL) was used for QoL. Frail older ICU survivors experience persistent physical, cognitive, and symptom-related challenges poorly captured by conventional QoL assessments, particularly regarding psychological and subjective experiences. The few studies addressing both frailty and QoL make it difficult to establish evidence, highlighting the need for standardised, multidimensional, patient-centred frameworks. Not applicable.
There is a constant quest to optimize outcomes of laparoscopic surgery and enhance patient experiences. In this review, we aim to describe the various impacts of dexamethasone in laparoscopic abdominal surgery. A systemic review of randomized controlled trials was performed in accordance with the PRISMA checklist, and the protocol was published in the electronic library (PROSPERO) with a search Accepted manuscript ACCEPTED MANUSCRIPT in Embase, Medline and Cochrane Library. Risk of bias was assessed according to the principles from Rob2. The review includes mainly cholecystectomies (n=26) and, in descending order, major gynecological surgery (n=10), gastric bypass (n=2), fundoplication (n=1), appendectomy (n=1), and inguinal hernia (n=1). The trials were all moderate-good quality providing evidence on postoperative nausea and vomiting while the (often secondary) outcomes on surgical stress markers were classified with a risk of bias from green to yellow according to RoB 2. All 41 studies except for seven reported as primary outcome on postoperative nausea and vomiting. In cholecystectomies, 85
The immunosuppressive action of dexamethasone may help reduce the risk of postoperative complications such as infection, adhesion formation, and delayed wound healing. Dexamethasone may mitigate tissue damage and hasten recovery by attenuating the inflammatory response, modulating immune cell activity, and reducing the release of pro-inflammatory cytokines. In this first randomized trial of dexamethasone in robotic hysterectomy, we aimed to evaluate its effect on reducing C-reactive protein (CRP) as a proxy marker of surgical stress. Women scheduled for robotic-assisted hysterectomy were recruited into a randomized trial comparing a preoperative dose of 24 mg dexamethasone with placebo. Blood tests were obtained, and visual analogue scale scores for pain, postoperative nausea and vomiting, and medication use during admission were recorded at 0, 4, 8, 12, and 24 h postoperatively. Among the 112 included women, postoperative CRP levels were lower in the dexamethasone group at 12 and 24 h. Postoperative nausea and vomiting over time were also reduced in the dexamethasone group (p = 0.039 without adjustment; p = 0.02 with adjustment). Changes in CRP were analyzed using repeated-measures analysis, showing highly significant differences both without and with adjustment for BMI, age, and baseline CRP (both p < 0.001). Overall, the dexamethasone group demonstrated substantially lower CRP levels during the postoperative period. Dexamethasone significantly reduced postoperative CRP levels, suggesting a potential role in further reducing surgical stress in robotic-assisted hysterectomy. European medical agency (EUDRACT no.2021-000874-28). 02.06.2021. CTIS Public Portal (European Medicines Agency) Registry of randomized clinical trials: NCT 04762381, “Effect of 24mg Dexamethasone Preoperatively on Surgical Stress, Pain and Recovery in Robotic-assisted Laparoscopic Hysterectomy”, 11th March 2022. ClinicalTrials.gov
Background and purpose: Effective pain management in older patients with a hip fracture is critical for postoperative recovery. Our primary objective was to compare intraoperative methadone with placebo on postoperative morphine consumption over 72 hours. Methods: Patients aged ≥ 60 years with hip fractures were randomized to receive methadone (0.10 mg/kg) or placebo intraoperatively. The primary outcome was postoperative morphine consumption measured in 24-hour intervals over 72 hours. Secondary outcomes included pain scores, time to mobilization, and discharge. Harms were assessed as adverse and serious adverse events. Results: 129 patients were included. The primary endpoint analysis demonstrated that postoperative morphine consumption over 72 hours differed significantly between groups (likelihood-ratio test, P = 0.02). Model-based estimates suggested lower morphine consumption in the methadone group at 0–24 hours (least square mean [LSM] 7.1 [SE 1.2] vs placebo 10.1 [SE 1.7] mg) and at 24–48 hours (4.1 [SE 0.8] vs placebo 5.3 [SE 0.9] mg). At 48–72 hours, the model suggested lower morphine consumption in the placebo group (3.2 [SE 0.6] vs methadone 4.6 [SE 0.9] mg). Secondary outcomes were similar between groups, except that time to hospital discharge was longer in the methadone group (LSM 5.6 vs 4.5 days; mean difference –1.3 days, 95% confidence interval –2.3 to –o.4; P < 0.01). Harms appeared comparable, although the low event rate precluded formal analysis. Conclusion: A single intraoperative dose of methadone significantly alters postoperative morphine consumption over 72 hours after hip fracture surgery, without major safety concerns.
Background/Objectives: Intensive postoperative pain is a common challenge after knee surgeries such as total knee arthroplasty, arthroscopy, cruciate ligament or meniscus repair, and fixation of tibial plateau or distal femoral fractures. This scoping review mapped and summarized non-regional postoperative analgesia strategies to provide an overview of available approaches when regional blocks or neuraxial anesthesia are not feasible. Methods: We followed established methodological guidance for scoping reviews and report the data in accordance with the PRISMA-ScR checklist. We searched PubMed/MEDLINE, EMBASE, Scopus, and ClinicalTrials.gov in January 2025. Eligible designs included randomized controlled trials, non-randomized trials, observational studies, case series, and pilot studies. Results: We screened 3390 records and assessed 332 in full text. A total of 43 studies met the inclusion criteria, and the literature was grouped into: (1) arthroplasty, (2) arthroscopy, (3) cruciate ligament or meniscus repair, and (4) tibial plateau or distal femoral fractures. We identified substantial heterogeneity in interventions, comparators, and outcome measures across the first three sets of literature but found no focused articles for tibial plateau or distal femoral fractures. Most studies evaluated multimodal approaches combining systemic analgesics with local periarticular or intraarticular techniques. Evidence on functional recovery and mobilization was limited. Conclusions: Current evidence on non-regional postoperative analgesia in knee surgery is fragmented and varies considerably in design, intervention, and reported outcomes. Multimodal regimens and pre-emptive NSAID use were frequently associated with reduced early postoperative pain and lower opioid requirements, although comparability across studies remains limited. As existing evidence largely focuses on outcomes during hospitalization, future research should prioritize standardized pain and functional outcome reporting and directly compare systemic and local multimodal strategies, while extending follow-up beyond discharge to better characterize sustained clinical relevance.
To evaluate clinical and paraclinical parameters at the time of abdominal closure following vacuum-assisted closure (VAC) therapy in patients with secondary peritonitis, and to identify associations to postoperative complications. This retrospective multicenter cohort study included patients with secondary peritonitis from the small intestine, colon, or rectum who underwent emergency laparotomy and VAC therapy at six hospitals in southern Denmark between 2010 and 2019. Clinical status and laboratory values obtained before abdominal closure were recorded. Complications within 30 days were graded using the Clavien-Dindo Classification. The cohort comprised 163 patients divided into two groups: 49 patients with postoperative complications and 114 without. Absence of bowel function (41
We aimed to perform a review focused on the effects of dexamethasone on markers of surgical stress in the context of laparoscopic abdominal surgery. This review was registered at PROSPERO. Published reports were evaluated with COVIDENCE, focusing on randomized controlled trials from the MEDLINE, EMBASE and CENTRAL databases. Studies were included if they compared a single intravenous dose of dexamethasone to placebo given preoperatively to adult patients undergoing laparoscopic or robotic assisted abdominal surgery under general anesthesia. The outcome of interest was inflammatory response in general and in particular c-reactive protein. Out of 588 references, we included seven studies. These involved a variety of surgical procedures, with cholecystectomies being the most common, and included mixed gender populations except in studies on gynecology surgery. Due to the heterogeneity in outcomes and the low number of studies no meta-analysis was performed. Levels of c-reactive protein was 38-60
Background Hip fractures cause extreme pain, primarily affecting the older and frail. The necessity of sufficient pain relief in combination with a lower tolerance for drugs makes the analgesic treatment of older patients difficult. A single dose of methadone might reduce postoperative pain and opioid consumption. However, the safety of using methadone for older and fragile patients is unknown. Aim Determine the maximal tolerable dose (MTD) of perioperative methadone in older hip fracture patients and assess the feasibility of this protocol for future clinical trials. Methods Hip fracture patients ≥60 years old were consecutively included at the hospital in the winter/spring of 2023. An adaptive algorithm allocated 0.10 mg/kg, 0.15 mg/kg, or 0.20 mg/kg of methadone to each patient, administered intravenously at the induction of anesthesia. The primary outcome was respiratory depression, which was monitored continuously. Occurrence required a dosage decrease, while absence allowed an increase. Registered Nurses at the orthopedic ward collected data using observation charts completed 6, 24, and 72 hours after surgery. Secondary outcomes include time spent in the post-anesthesia care unit (PACU), verbal rating pain score (VRS), opioid consumption, and nausea/vomiting. Results 30 patients completed the study. Nine received 0.10 mg/kg, and 21 received 0.15 mg/kg. Three patients experienced respiratory depression in PACU, all receiving 0.15 mg/kg methadone and undergoing general anesthesia. None of the spinal anesthesia patients or those receiving 0.10 mg/kg experienced respiratory depression. Conclusion Methadone is an effective analgesic for hip fracture surgery. The data suggests that the maximal tolerable dose of methadone in older hip fracture patients is 0.10 mg/kg. This study proves the feasibility of our trial setup and provides a foundation for future randomized controlled trials. Additionally, the findings suggest that the tolerability of methadone may vary depending on the type of anesthesia used, which merits further investigation.
Introduction Sedation ensures a child remains motionless during a procedure and decreases anxiety. Several pharmacologic regimes exist for paediatric sedation. However, often, intravenous cannulation is required, causing distress for the child. Creating a low-stress environment for children during medical procedures is crucial. Intranasal dexmedetomidine offers a promising alternative by either removing the need for intravenous cannulation or significantly reducing stress and anxiety when cannulation is necessary. We aim to investigate the safety and efficiency of sedating children with intranasal dexmedetomidine. Methods and analysis We will systematically search MEDLINE (Ovid), Embase (Ovid), CINAHL (EBSCO), CENTRAL, Clinicaltrials.gov, and the WHO ICTRP portal. We will include all randomized controlled trials (RCT) that investigate the use of intranasal dexmedetomidine compared to alternative sedatives for premedication or sedation of children. Two researchers will independently screen title/abstract and full-text articles for eligibility using Covidence. Our primary outcome is sedation success rate. RCTs that meet the inclusion criteria will form the unit of analysis. Data extracted from each study will be presented in table format (S2 Table). Information on parameters that describe safety and efficiency outcomes will be extracted and analysed. Outcome data will be reported as risk ratios and 95% confidence intervals (CI) for dichotomous outcomes or mean and standardized mean differences with 95% CI for continuous outcomes. The assessment of statistical heterogeneity will be examined using Chi2- and I2-statistics. PROSPERO registration number CRD42024532993 Discussion Sedation with intranasal dexmedetomidine is not common practice in all countries, though the medicament has the potential to provide a child-friendly approach to sedation and premedication. Reviews on the area are conflicting, and new RCT studies have been published. Our systematic review aims to comprehensively assess intranasal paediatric sedation, focusing on dexmedetomidine and guiding clinicians in daily decision-making for optimal paediatric sedation.
OBJECTIVES:Randomized clinical trials informing clinical practice (e.g., like large, pragmatic, and late-phase trials) should ideally mostly use harmonized outcomes that are important to patients, family members, clinicians, and researchers. Core outcome sets for specific subsets of ICU patients exist, for example, respiratory failure, delirium, and COVID-19, but not for ICU patients in general. Accordingly, we aimed to develop a core outcome set for adult general ICU patients. DESIGN:We developed a core outcome set in Denmark following the Core Outcome Measures in Effectiveness Trials Handbook. We used a modified Delphi consensus process with multiple methods design, including literature review, survey, semi-structured interviews, and discussions with initially five Danish research panels. The core outcome set was internationally validated and revised based on feedback from research panels in all countries. SETTING:There were five Danish research panels and 17 panels in 13 other countries. Interviews and the three-round Delphi survey was conducted in Denmark, followed by validation of the core outcome set across 14 countries in Europe, Australasia, and India. SUBJECTS:Adult ICU survivors, family members, clinicians, and researchers. INTERVENTIONS:None. MEASUREMENTS AND MAIN RESULTS:We identified 329 published outcomes, of which 50 were included in the 264 participant Delphi survey. In semi-structured interviews of 82, no additional outcomes were added. The first Delphi survey round was completed by 249 (94%) participants, and 202 (82%) contributed to the third and final round. The initial core outcome set comprised six outcomes. International validation involved 217 research panel members and resulted in the final core outcome set comprising survival, free of life support, free of delirium, out of hospital, health-related quality of life, and cognitive function. CONCLUSIONS:We developed and internationally validated a core outcome set with six core outcomes to be used in research, specifically clinical trials involving adult general ICU patients.
INTRODUCTION:A main feature of CDH is lung hypoplasia and the related presentation of pulmonary hypertension and cardiac dysfunction. Multiple factors influence pulmonary status after CDH: degree of hypoplasia, ventilator-induced injury, altered growth and development of pulmonary structures, reduced diaphragm function and chest wall abnormalities. The evolution of pulmonary sequela in this population is still unclear. We aimed to describe the pulmonary status of our population of CDH-survivors and evaluated on risk factors. METHODS:CDH-survivors (1998-2015) were included and performed lung function tests and chest X-rays. RESULTS:Fifty-one (51/71, 71.8%) participated. Median age was 12.2 (5.5-21.4) years, 28 (54.9%) male, 42 (82.4%) had left-sided hernias, 10 (19.6%) needed patch-repair and median length of stay in hospital was 28.0 (IQR 18.5-61.6) days in Table 1. Spirometry including bronchodilator response (BDR)-test, body plethysmography, and diffusion capacity, were available for 48, 42, and 40 participants. The mean (SD) z-score for FEV1 and FVC was -0.26 (1.70) and -0.28 (1.70). Twenty-one (43.8%) had obstructive patterns and six had positive BDR. TLC mean (SD) z-score was -0.18 (1.10). Four showed restricted/mixed patterns and 13 showed signs of hyperinflation. Increased RV/TLC-ratio and reduced FEV1 was associated with longer time on mechanical ventilation. Diffusion capacity was decreased in three cases. Chest X-ray revealed hernia recurrence (13.9%) and scoliosis (38.9%). CONCLUSION:Mild obstructive impairment and hyperinflation was frequent in our CDH cohort and only a small subset of restrictive disorders were identified. We advocate follow-up by a specialized multidisciplinary team through childhood and into adulthood.
Background and Aim The impact of hysterectomy on women's sexual functioning is a subject of debate. Some women report improvements in sexual function post-surgery, often due to the relief of symptoms like pain or bleeding, while others experience sexual dysfunction following the procedure. Factors such as preoperative health and the type of hysterectomy performed (e.g., laparoscopic or robotic) may contribute to these variations. Robotic-assisted hysterectomy, as a minimally invasive surgical method, was well-received due to its benefits, including reduced postoperative pain, quicker recovery, and shorter hospital stays. Dexamethasone, a corticosteroid commonly used in multimodal anesthesia regimens and known for its anti-inflammatory properties, can reduce surgical stress, decrease postoperative pain, and hasten recovery. The aim of this randomized trial was to assess whether adding dexamethasone to a robotic hysterectomy procedure would further improve postoperative outcomes besides of lowering inflammatory response, particularly regarding sexual functioning. Methods The study-recruited women scheduled for robotic-assisted hysterectomy and randomized into two groups: One receiving 24 mg of dexamethasone preoperatively and the other receiving a placebo. Various measures were taken, including blood tests, pain assessments using the visual analogue scale (VAS), and reports on postoperative vomiting, nausea, and medication usage at five time points: 0, 4, 8, 12, and 24 hours postoperatively. The primary outcome included inflammatory response and, secondarily, sexual functioning measures such as urinary incontinence during sex, orgasm intensity, and frequency of sexual desire. Results A total of 112 women participated, with complete data available from all participants for blood tests, medical interventions, and VAS measures at all time points. No significant differences were found in basic characteristics between the dexamethasone and placebo groups. However, the study observed the following differences in sexual functioning: Women in the dexamethasone group had a higher frequency of wanting sex at each weekly follow-up compared to the placebo group (p = 0.018). Orgasm intensity was significantly higher in the dexamethasone group (p = 0.044). The high and better score in QoR-15 at week 4 was associated with wanting more sex (p=0.04) and less pain during intercourse (p=0.047). No differences were found in the resumption of sex within the four-week study period, pain during sex or incontinency during intercourse. Conclusion The addition of dexamethasone in robotic-assisted hysterectomy was associated with an increased frequency of sexual desire and more intense orgasms in the first four weeks postoperatively. This suggests that dexamethasone may positively affect certain aspects of sexual functioning in women undergoing this procedure. These findings highlight the potential benefits of dexamethasone in the postoperative recovery phase, but further research may be needed to understand the full scope of its effects on sexual health after hysterectomy.
Shock is a condition with high mortality even with early intervention and treatment. Usual care for shock and hypotension in the Emergency Department (ED) is intravenous fluid resuscitation which can lead to fluid overload and other complications. When fluid therapy fails or risk of complications are high, the next treatment step is the use of vasopressors for stabilisation. Noradrenaline therapy for hypotension and shock are commonly used in ED’s outside Scandinavia, but the evidence on the optimal initiation time is sparse. The lack of noradrenaline therapy in Scandinavia provides a unique environment to investigate the possible implications of early initiation. The aim of this trial is to investigate whether the use of early initiated noradrenaline compared to ED fluid therapy can improve blood pressure goals and by that, reduce the need for ICU admittance. This protocol describes a pragmatic, multi-center, superiority randomized controlled trial, randomizing patients with hypotension to intervention or control. Eligible patients are ≥ 18-year-old who have received at least 500 ml intravenous fluids (including prehospital administration), and without suspected cardiogenic, haemorrhagic, anaphylactic, or neurogenic causes, or require direct ICU admittance due to non-hemodynamic severe organ failure. The intervention group receives noradrenaline initiated at 0.05 mcg/kg/min with a maximum of 0.15 mcg/kg/min through a peripheral venous catheter for up to 24 h. The control group receives usual care. Treatment is targeted for a systolic blood pressure ≥ 100 mmHg, a mean arterial pressure ≥ 65 mmHg or a clinician defined blood pressure target. We require a sample size of 320 patients to show a significant difference in proportion of patients achieving shock control within 90 min (primary endpoint). Key secondary outcomes include ICU free days alive within 30-days and 30-day all-cause mortality. Previous prospective randomized trials on early peripheral noradrenaline treatment for shock are sparse and are investigated in settings where noradrenaline use is already usual care. Since noradrenaline are not used as standard treatment for shock in Scandinavian EDs, this provides a unique opportunity not only to investigate the early initiation of noradrenaline for shock, but also comparing it directly to ED fluid only approach. Trial registration: EU CT ID 2023-504584-16-00. ClinicalTrials.gov NCT05931601. URL: https://classic.clinicaltrials.gov/ct2/show/NCT05931601
BACKGROUND:Adult intensive care unit (ICU) patients receive many interventions, but few are supported by high-certainty evidence. Randomised clinical trials (RCTs) are essential for trustworthy comparisons of intervention effects, but conventional RCTs are costly, cumbersome, inflexible, and often turn out inconclusive. Adaptive platform trials may mitigate these issues and have higher probabilities of obtaining conclusive results faster and at lower costs per participant. METHODS:The Intensive Care Platform Trial (INCEPT) is an investigator-initiated, pragmatic, randomised, embedded, multifactorial, international, adaptive platform trial including adults acutely admitted to ICUs. INCEPT will assess comparable groups of interventions (primarily commonly used interventions with clinical uncertainty and practice variation) nested in domains. Interventions may be either open-label or masked. New domains will continuously be added to the platform. INCEPT assesses multiple core outcomes selected following substantial stakeholder involvement: mortality, days alive without life support/out of hospital/free of delirium, health-related quality of life, cognitive function, and safety outcomes. Each domain will use one of these core outcomes as the primary outcome. INCEPT primarily uses Bayesian statistical methods with neutral, minimally informative or sceptical priors, adjustment for important prognostic baseline variables, and calculation of absolute and relative differences in the intention-to-treat populations. Domains and intervention arms may be stopped for superiority/inferiority, practical equivalence, or futility according to pre-specified adaptation rules evaluated using statistical simulation or at pre-specified maximum sample sizes. Domains may use response-adaptive randomisation, meaning that more participants will be allocated to interventions with higher probabilities of being superior. CONCLUSIONS:INCEPT provides an efficient, pragmatic, and flexible platform for comparing the effects of many interventions used in adult ICU patients. The adaptive design enables the trial to use accumulating data to improve the treatment of future participants. INCEPT will provide high-certainty, conclusive evidence for many interventions, directly inform clinical practice, and thus improve patient-important outcomes.
Venous cannulation is widely used in healthcare systems, and for many patients, it is painful and distressing. We hypothesized that the rapid onset of cryospray use would reduce pain from venous cannulation compared to the use of a placebo spray. The trial was a prospective randomized placebo-controlled trial including 130 adult patients scheduled for elective surgery. Patients were randomized to receive either cryospray or placebo before venous cannulation. The primary outcome was patient-reported pain from vein puncture. There were no differences in the baseline variables between the two groups with respect to age, sex, height, weight or ASA class. Patients in the cryospray group indicated more pain or discomfort with the application of the spray (0 (0-2.5)) than with the application of the placebo spray (0 (0–0)) (P < 0.005), as measured by the Numeric Rating Scale (NRS). Patients in the placebo group reported more pain with vein puncture than did those in the cryospray group (1 (0–3) vs. 3 [2–5], P < 0.005). When asked if the patient would have the same spray in case of canulation again, 57 patients from the cryospray group reported yes compared to 34 patients in the control group (P < 0.005). This randomized study found that cryospray significantly reduced pain during venous cannulation without increasing procedure difficulty. Patients reported lower pain scores and a greater preference for cryospray in future procedures, supporting its use as an effective pain relief method in elective surgery. ClinicalTrials. gov Identifier: NCT04865783 (28-04-2021).
Abstract Background Life-sustaining therapy, including heart and lung resuscitation and transfer to the intensive care department, is demanding for patients and relatives and utilizes large amounts of healthcare resources. For older patients acutely admitted to the hospital, very sparse data exist on decision making about life-sustaining therapy. Methods Retrospective data were extracted from patients ≥ 70 years old who were acutely admitted to the hospital. Age, sex, clinical frailty scale score and Charlson comorbidity index were manually extracted from patients’ files. Furthermore, data about life-sustaining treatment decisions were extracted. This was further divided into decisions documented within 24 h from admission or during the hospital stay. Results Data were extracted for 200 patients with a median age of 80 years. Patients had a Charlson Comorbidity Index of 6 (5–8 IQR) and a Clinical Frailty Scale (CFS) score of 5 (3–6 IQR). During the first 24 h, 61 patients (30.5%) had a written decision about heart and cardiopulmonary resuscitation (CPR), and 52 patients (26%) had written information about intensive care therapy. A total of 93 patients (46.5%) had a written decision about cardiopulmonary resuscitation (CPR), intensive care therapy or both during their hospital stay. With increasing Charlson Comorbidity Index and Clinical Frailty Scale scores, more patients had decisions about limitations in therapy documented in their files. Conclusions Within the first 24 h, 30.5% of the patients had a written decision about cardiopulmonary resuscitation (CPR), and 26% had written information about intensive care therapy. These numbers increased to 46.5% of patients who had a decision made during their hospital stay whether they were candidates for either cardiopulmonary resuscitation (CPR), intensive care therapy or both. These data suggest that further work should be done to determine the limitations of therapy early on the admission for all older frail acutely admitted patients.
Abstract Background Hip fractures are a source of severe pain among the elderly population and pose challenges due to limited analgesic tolerance. Perioperative methadone has shown promise in our pilot study suggesting a safe dose of 0.10 mg/kg, prompting further investigation into its benefits for elderly hip fracture patients. Methods This study employs a double-blinded randomized controlled trial to assess the analgesic effects of a single dose of methadone during hip fracture surgery. Patients aged ≥ 60 years are consecutively enrolled and randomized to receive either perioperative methadone (treatment group) or a saline solution (placebo group). A sample size of 130 patients is required for 88% statistical power. The medication is administered intravenously at anesthesia induction and monitored until discharge. A follow-up observation is conducted 3 months post-surgery. Discussion Primary outcome: Daily consumption of opioids within the first 3 days after surgery. Secondary outcomes include pain, mobility, nausea, vomiting, time to discharge, need for antidote, delirium, and constipation. The 3-month follow-up includes opioid use, pain, EQ-5D-5L scores, mobility, and persistent side effects. If statistically significant advantages are found in the treatment group, perioperative methadone could be considered as standard care for hip fracture patients, potentially enhancing their pain management. The study’s outcomes will provide insights into the feasibility and effectiveness of incorporating methadone into routine clinical practices for this patient group. Trial registration ClinicalTrials.gov ID: NCT06086171, submitted 4. October 2023. EU-CT: 2023–506252-24–00, UTN: U1111-1294–6125.
Background and Objectives: Breast cancer surgeries offer challenges in perioperative pain management, especially in the presence of inherent risk of postoperative nausea and vomiting (PONV) and postmastectomy pain syndrome (PMPS). Inappropriate opioid consumption was speculated as one of the reasons. Through this study, the influence of objective pain monitoring through a nociception level monitor (NOL) on perioperative course in breast surgeries was investigated. Materials and Methods: This was a prospective randomized study conducted at a regional hospital. Sixty female patients posted for breast cancer surgery were randomized equally into study and control groups. Both groups were monitored using BIS and NOL, but in the control group, the NOL monitor was blinded by a cover. Both groups received propofol and remifentanil through target-controlled infusions (TCIs) along with interpectoral, pectoserratus (PECS II), and superficial pectointercostal block. The primary outcome was intraoperative opioid consumption. Secondary outcomes were PONV, eligibility for discharge from the recovery room, and symptoms of PMPS after three months. Results: Two patients were excluded. The study group received significantly less remifentanil (0.9 mg in the study group vs. 1.35 mg in the control group, p = 0.033) and morphine (2.5 mg in study group vs. 5 mg in control group, p = 0.013). There was no difference in PMPS symptoms between the groups. The study group showed longer duration of inadequate analgesia (i.e., 7% vs. 10% of the total intraoperative period in control and study group, respectively, p = 0.008). There was no difference in time to eligibility for discharge from the recovery room between the groups. Conclusions: NOL monitor-guided analgesic delivery reduces intraoperative opioid consumption. No difference was demonstrated on PONV, eligibility for discharge from the recovery room, or PMPS symptoms.
Introduction Rises in average life expectancy, increased comorbidities and frailty among older patients lead to higher admission rates to intensive care units (ICU). During an ICU stay, loss of physical and cognitive functions may occur, causing prolonged rehabilitation. Some functions may be lost permanently, affecting quality of life (QoL). There is a lack of understanding regarding how many variables are relevant to health-related outcomes and which outcomes are significant for the QoL of frail, elderly patients following discharge from the ICU. Therefore, this scoping review aims to identify reported variables for health-related outcomes and explore perspectives regarding QoL for this patient group.Methods and analysis The Joanna Briggs Institute guidelines for scoping reviews will be employed and original, peer-reviewed studies in English and Scandinavian languages published from 2013 to 2023 will be included. The search will be conducted from July 2023 to December 2023, according to the inclusion criteria in Embase, MEDLINE, PsycINFO and CINAHL. References to identified studies will be hand-searched, along with backward and forward citation searching for systematic reviews. A librarian will support and qualify the search strategy. Two reviewers will independently screen eligible studies and perform data extraction according to predefined headings. In the event of disagreements, a third reviewer will adjudicate until consensus is achieved. Results will be presented narratively and in table form and discussed in relation to relevant literature.Ethics and dissemination Ethical approval is unnecessary, as the review synthesises existing research. The results will be disseminated through a peer-reviewed publication in a scientific journal.