Whether the use of inhaled or intravenous sedation affects outcomes differentially in mechanically ventilated adults with acute respiratory distress syndrome (ARDS) is unknown. To determine the efficacy and safety of inhaled sevoflurane compared with intravenous propofol for sedation in patients with ARDS. Phase 3 randomized, open-label, assessor-blinded clinical trial conducted from May 2020 to October 2023 with 90-day follow-up. Adults with early moderate to severe ARDS (defined by a ratio of Pao2 to the fraction of inspired oxygen of <150 mm Hg with a positive end-expiratory pressure of ≥8 cm H2O) were enrolled in 37 French intensive care units. Patients were randomized to a strategy of inhaled sedation with sevoflurane (intervention group) or to a strategy of intravenous sedation with propofol (control group) for up to 7 days. The primary end point was the number of ventilator-free days at 28 days; the key secondary end point was 90-day survival. Of 687 patients enrolled (mean [SD] age, 65 [12] years; 30% female), 346 were randomized to sevoflurane and 341 to propofol. The median total duration of sedation was 7 days (IQR, 4 to 7) in both groups. The number of ventilator-free days through day 28 was 0.0 days (IQR, 0.0 to 11.9) in the sevoflurane group and 0.0 days (IQR, 0.0 to 18.7) in the propofol group (median difference, −2.1 [95% CI, −3.6 to −0.7]; standardized hazard ratio, 0.76 [95% CI, 0.50 to 0.97]). The 90-day survival rates were 47.1% and 55.7% in the sevoflurane and propofol groups, respectively (hazard ratio, 1.31 [95% CI, 1.05 to 1.62]). Among 4 secondary outcomes, sevoflurane was associated with higher 7-day mortality (19.4% vs 13.5%, respectively; relative risk, 1.44 [95% CI, 1.02 to 2.03]) and fewer intensive care unit–free days through day 28 (median, 0.0 [IQR, 0.0 to 6.0] vs 0.0 [IQR, 0.0 to 15.0]; median difference, –2.5 [95% CI, –3.7 to –1.4]) compared with propofol. Among patients with moderate to severe ARDS, inhaled sedation with sevoflurane resulted in fewer ventilator-free days at day 28 and lower 90-day survival than sedation with propofol. ClinicalTrials.gov Identifier: NCT04235608
Ulipristal has recently been suspected to be hepatotoxic by the European Medicines Agency but the evidence base for hepatotoxicity is sparse. This is a brief formal report of a patient administered ulipristal for 6-8 weeks and who developed acute liver failure leading to liver transplantation. The explanted liver showed extensive hepatocyte necrosis and inflammation compatible with drug-induced liver injury and cirrhosis. The usual causes of acute hepatitis and cirrhosis were eliminated. There were no other potential causative drugs. This case suggests that ulipristal may cause acute hepatitis, with pre-existing cirrhosis probably contributing to the severity of liver injury observed in this case. Ulipristal prescribers must remain vigilant and monitor liver function in their patients. (C) 2020 Elsevier Masson SAS. All rights reserved.
Hepatectomy is a surgery with high postoperative complication rates. Enhanced recovery after surgery (ERAS) clinical pathways in liver surgery have been studied and may become a standard of care. However, few specific recommendations have been published so far.The aim of this study was to assess the efficacy and safety of the enhanced recovery program in liver surgery.Randomised controlled trials (RCTs) comparing ERAS group with traditional care published between 2007 and 2017 were included in this review. The outcomes were length of stay (LoS), complications, mortality and readmission rate for all liver surgeries except transplantation.Five hundred and twenty-four patients randomised in 4 RCTs were analysed. Two hundred and fifty-four patients were in ERAS group and 270 patients in traditional care (TC) group. Two studies compared cares in laparoscopic surgery and 2 in open surgery. Postoperative LoS was significantly lower in the ERAS group whereas readmission and mortality rate were similar. ERAS group had also significant lower complication rate in 2 studies of the 4. The complication rate in the 2 other studies was similar.ERAS protocols in liver surgery appeared to be safe and effective. Recent recommendations from the ERAS group in liver surgery are the only ones published so far. Other studies evaluating ERAS components in liver surgery and recommendations from scientific societies are needed to spread this clinical care pathway.
Thirty-day readmission after surgery has been proposed as a quality-of-care indicator. We explored the effect of postoperative rehabilitation on readmission risk after groin hernia repair. We used the French National Discharge Database to identify all index hospitalizations for groin hernia repair in 2011. Readmissions within 30 days of discharge were clinically classified in terms of their relationship to the index stay. We used logistic regression to adjust the risk of readmission for patient, procedure and hospital factors. Among 122,952 index hospitalizations for inguinal hernia repair, 3,357 (2.7%) related 30-day readmissions were recorded. Reiterated analyses indicated that readmission risk was consistently associated with patient complexity: age (per year after 60 years, OR 1.03, 95% CI 1.02–1.03, P < 0.001), hospitalization within the previous year (OR 1.56, 95% CI 1.44–1.69, P < 0.001), and increasing severity and combination of co-morbidities. Postoperative rehabilitation was identified as a protective factor (OR 0.56, 95% CI 0.46–0.69, P < 0.001). Older patients and those with greater comorbidity are at elevated risk of readmission after inguinal hernia repair. Postoperative rehabilitation may reduce this risk. Further studies are warranted to confirm the protective effect of postoperative rehabilitation.
BACKGROUND:Avoidance of excessive sedation and subsequent prolonged mechanical ventilation in intensive care units (ICUs) is recommended, but no data are available for critically ill postoperative patients. We hypothesised that in such patients stopping sedation immediately after admission to the ICU could reduce unnecessary sedation and improve patient outcomes. METHODS:We did a randomised, parallel-group, clinical trial at three ICUs in France. Stratified randomisation with minimisation (1:1 via a restricted web platform) was used to assign eligible patients (aged ≥18 years, admitted to an ICU after abdominal surgery, and expected to require at least 12 h of mechanical ventilation because of a critical illness defined by a Sequential Organ Failure Assessment score >1 for any organ, but without severe acute respiratory distress syndrome or brain injury) to usual sedation care provided according to recommended practices (control group) or to immediate interruption of sedation (intervention group). The primary outcome was the time to successful extubation (defined as the time from randomisation to the time of extubation [or tracheotomy mask] for at least 48 h). All patients who underwent randomisation (except for those who were excluded after randomisation) were included in the intention-to-treat analysis. This study is registered with ClinicalTrials.gov, number NCT01486121. FINDINGS:Between Dec 2, 2011, and Feb 27, 2014, 137 patients were randomly assigned to the control (n=68) or intervention groups (n=69). In the intention-to-treat analysis, time to successful extubation was significantly lower in the intervention group than in the control group (median 8 h [IQR 4-36] vs 50 h [29-93], group difference -33·6 h [95% CI -44·9 to -22·4]; p<0·0001). The adjusted hazard ratio was 5·2 (95% CI 3·1-8·8, p<0·0001). INTERPRETATION:Immediate interruption of sedation in critically ill postoperative patients with organ dysfunction who were admitted to the ICU after abdominal surgery improved outcomes compared with usual sedation care. These findings support interruption of sedation in these patients following transfer from the operating room. FUNDING:Délégation à la Recherche Clinique et à l'Innovation du Groupement de Coopération Sanitaire de la Mission d'Enseignement, de Recherche, de Référence et d'Innovation (DRCI-GCS-MERRI) de Montpellier-Nîmes.
High-flow nasal cannula oxygen (HFNC) has the potential to provide apnoeic oxygenation. We decided to assess in a proof-of-concept study whether the addition of HFNC to non-invasive ventilation (NIV) could reduce oxygen desaturation during intubation, compared with NIV alone for preoxygenation, in severely hypoxaemic intensive care unit (ICU) patients with respiratory failure.
High-flow nasal cannula (HFNC) oxygen therapy is attracting increasing interest in acute medicine as an alternative to standard oxygen therapy; however, its use to prevent hypoxaemia after major abdominal surgery has not been evaluated. Our trial was designed to close this evidence gap.
Cet article ne se veut pas un guide méthodologique, mais une aide à tous les professionnels de santé qui sont confrontés, depuis la T2A (tarification à l'activité), à une logique économique des soins. Toutes ces nouvelles notions: T2A, PMSI (Programme de Médicalisation du Système d'Information), CCAM (Classification Commune des Actes Médicaux), GHM (Groupe Homogène de Malade), GHS (Groupe Homogène de Séjour), RSS (Résumé de Sortie Standardisé), CIM10 (Classification Internationale des Maladies), etc., nous ont été imposées sans beaucoup d'explications, alors que les choses sont loin d'être simples et que leurs différentes versions se succèdent.Il est important de comprendre la T2A dans sa complexité, pour ne pas la subir sans réagir et ne pas se laisser entraîner par ses effets pervers. Même dans les établissements qui pratiquent le codage PMSI de façon centralisée, il faut avoir l'œil vigilant sur la cohérence et surtout sur l'optimisation des séjours car il s'agit non seulement de l'activité de chacun d'entre nous et des honoraires dans le secteur privé, mais aussi des recettes de l'établissement.This article doesn't intend to be a methodological guide but an assistance to all health professionals who find themselves confronted with an economical logic of the medical care since the T2A.All these new concepts: T2A, PMSI(Medical Program of System Information), CCAM, DRG (Diagnosis Related Groups), RSS, CIM10 (International Classification of Diseases) etc. have been imposed without much explanations when things are far from being simple and one version follows another.It matters to understand how complex the T2A is in order to not be bound by its damages without reacting and to avoid its perverse effects. Even in establishments that use centralised PMSI, a careful eye has to be kept on the coherence and mostly the optimisation of the patients stays because it's about our activity, professional's fees in the private sector and the establishment's takings.
AIMS:To assess the impact of a simple computer-based decision-support system (computer help) on the quality of nutrition support orders and patients' outcome in Intensive-Care Unit (ICU). METHODS:This quality-improvement study was carried out in a 16-bed medical-surgical ICU in a French university hospital. All consecutive patients who stayed in ICU more than 10 days with non-oral feeding for more than 5 days were retrospectively included during two 12-month periods. Prescriptions of nutrition support were collected and compared to French national guidelines as a quality-improvement process. A computer help was constructed using a simple Excel-sheet (Microsoft(TM)) to guide physicians' prescriptions according to guidelines. This computer help was displayed in computers previously used for medical orders. Physicians were informed but no systematic protocol was implemented. Patients included during the first (control group) and second period (computer help group) were compared for achievement of nutrition goals and ICU outcomes. RESULTS:The control and computer help groups respectively included 71 and 95 patients. Patients' characteristics were not significantly different between groups. In the computer help group, prescriptions achieved significantly more often 80% of nutrition goals for calorie (45% vs. 79% p<0.001) and nitrogen intake (3% vs. 37%, p<0.001). Incidence of nosocomial infections decreased significantly between the two groups (59% vs. 41%, p = 0.03). Mortality did not significantly differ between control (21%) and computer help groups (15%, p = 0.30). CONCLUSIONS:Use of a widespread inexpensive computer help is associated with significant improvements in nutrition support orders and decreased nosocomial infections in ICU patients. This computer-help is provided in electronic supplement.
Scheduled and/or thoracic, abdominal surgeries increase the risk of respiratory postoperative complications. In patients with chronic respiratory failure, preoperative evaluation should be performed to evaluate respiratory function in aim to optimize perioperative management. Preoperative gas exchange abnormalities (hypoxemia or hypercapnia) are associated with respiratory postoperative complications. Respiratory physiotherapy and prophylactic non-invasive ventilation should be integrated in a global rehabilitation management for cardiothoracic or abdominal surgery procedures, which are at high risk of postoperative respiratory dysfunction. Stopping tobacco consummation should be benefit, but decease risk of postoperative complications is relevant only after a period for 6 to 8 weeks of cessation. Bronchodilatator aerosol therapy (beta-agonists and atropinics) and inhaled corticotherapy allow a rapid preparation for 24 to 48 h. Systematic preoperative antibiotherapy should not be recommended.
OBJECTIVE:To define the causes of mortality of patients who died within the first three months after a liver transplantation.TYPE OF STUDY:Retrospective, observational, and single centre study.PATIENTS AND METHODS:Between March 1989 and July 2010, all patients who died within three months after a liver transplantation were included. Demographic characteristics, preoperative and peroperative data, donor characteristics, postoperative complications and causes of mortality were collected.RESULTS:Among the 788 performed liver transplantations, 76 patients died in intensive care unit (11%). The main indications of liver transplantation were alcoholic cirrhosis (30%), hepatitis C (28%), hepatocarcinoma (15%), primitive or secondary biliary cirrhosis (10%). Fifty percent of the patients were categorized as Child C. The main causes of death were non-function or dysfunction with retransplantation contra-indication graft (18%), sepsis (18%), neurological complications (12%), hemorrhagic shock (13%), (9%), multiorgan failures (5%), cardiac complications (6%).CONCLUSION:In this study, the main causes of mortality were infectious, neurological and hemorrhagic. These results emphasize the necessity for better control of sepsis, haemorrhage and immunosupressors.
L’intubation trachéale en réanimation est fréquemment réalisée chez un patient instable et est associée à un risque élevé de complications (20 à 50 %) menaçant le pronostic vital. Alors que la préoxygénation chez les patients dont l’intubation est prévue difficile au bloc opératoire est largement utilisée, les indications et les techniques en soins intensifs sont moins connues. Dans cette revue, nous rappelons les concepts physiologiques de la préoxygénation et montrons son intérêt dans la sécurisation de la procédure d’intubation du patient critique. Nous rapportons également l’intérêt de la préoxygénation en ventilation non-invasive sur l’oxygénation et le risque d’hypoxie au décours immédiat de l’intubation.
Un secolo di storia mostra l’evoluzione dell’anestesia e dell’analgesia peridurali, tecniche ampiamente sviluppate con numerose indicazioni chirurgiche, ostetriche e analgesiche. Le tecniche, i materiali, i farmaci e le indicazioni subiscono tuttavia evoluzioni costanti, imponendo un regolare aggiornamento delle conoscenze in questo settore. Questo sviluppo, ampiamente suffragato dalle recenti raccomandazioni della Société française d’anesthésie et de réanimation, mette in relazione queste evoluzioni con i dati farmacologici e con le tecniche recenti. Permette anche di rivalutare le indicazioni classiche e di precisare le condizioni di impiego nelle indicazioni più recenti. Largamente conosciute, le tecniche peridurali restano tuttavia fonti potenziali di incidenti e di complicanze, di seguito menzionate in modo esauriente.
BACKGROUND:Noninvasive positive-pressure ventilation (NPPV) with pressure support-ventilation and positive end-expiratory pressure are effective in providing oxygenation during intubation in hypoxemic patients. We hypothesized administration of oxygen (O2) using NPPV would more rapidly increase the end-tidal O2 concentration (ETO2) than preoxygenation using spontaneous ventilation (SV) in morbidly obese patients. METHODS:Twenty-eight morbidly obese patients were enrolled in this prospective randomized study. Administration of O2 for 5 min was performed either with SV group or with NPPV (pressure support = 8 cm H2O, positive end-expiratory pressure = 6 cm H2O) (NPPV group). ETO2 was measured using the anesthesia breathing circuit, and is expressed as a fraction of atmospheric concentration. The primary end-point was the number of patients with an ETo(2) >95% at the end of O2 administration. Secondary end-points included the time to reach the maximal ETO2 and the ETO2 at the conclusion of O2 administration. RESULTS:A larger proportion of patients achieved a 95% ETO2 at 5 min with NPPV than SV (13/14 vs 7/14, P = 0.01). The time to reach the maximal ETO2 was significantly less in the NPPV than in the SV group (185 +/- 46 vs 222 +/- 42 s, P = 0.02). The mean ETO2 at the conclusion of O2 administration was larger in the NPPV group than the SV group (96.9 +/- 1.3 vs 94.1 +/- 2.0%, P < 0.001). A modest, although significant, increase in gastric distension was observed in the NPPV group. No adverse effects were observed in either group. CONCLUSION:Administration of O2 via a facemask with NPPV in the operating room is safe, feasible, and efficient in morbidly obese patients. In this population NPPV provides a more rapid O2 administration, achieving a higher ETO2.
BACKGROUND AND OBJECTIVES:Unlike for intensive care unit and home mechanical ventilators, no study has evaluated the user-friendliness of the recently introduced new anaesthesia workstations. METHODS:We performed a prospective study to evaluate the user-friendliness of four anaesthesia workstations, which were categorized into two groups: first-generation (Kion) and second-generation (Avance, Felix and Primus). Twenty users (12 nurse-anaesthetists and 8 anaesthesiologists) from three different anaesthesia departments at the same univeristy hospital participated in the study. The user-friendliness scale evaluated 10 criteria, including two design and monitoring criteria, four maintenance criteria and four ventilation use criteria. Each criterion was evaluated from 0 (poor) to 10 (excellent). RESULTS:The mean score obtained for the first-generation workstation was lower than those obtained for the three second-generation workstations (P < 0.05). No significant differences in the overall user-friendliness score was observed for the three second-generation workstations. The first-generation workstation obtained a significantly lower score than the three second-generation workstations for the design criteria (P < 0.01). For the screen criteria, the highest score was obtained by Felix, which has the largest screen and associated characters. For the main maintenance criteria, Kion and Felix obtained the lowest scores. No significant differences between the four anaesthesia workstations were found for only three of the user-friendliness criteria (self-test, alarms and settings). CONCLUSIONS:Anaesthesia machines have benefited from considerable advances in design and technology. This novel user-friendliness scale revealed that the most recent workstations were more appreciated by users than the first-generation of anaesthesia workstations. This user-friendliness scale may help the anaesthetic staff to 'consensually' choose the future workstation for their anaesthesia department.
OBJECTIVES Little is known about the physiologic and clinical effects of noninvasive positive pressure ventilation (NPPV) in patients who have acute respiratory failure (ARF) after abdominal surgery. We evaluated our clinical experience with the use of NPPV in the treatment of ARF after abdominal surgery. METHODS We prospectively evaluated NPPV use during a 2-year period in a medical-surgical ICU of a university hospital. We documented demographic and diagnostic data, gas exchange, and clinical outcomes. We compared patients who were not intubated to those who were intubated after a trial of NPPV. RESULTS Of 72 patients with ARF after abdominal surgery who were treated with NPPV, 48 patients avoided intubation (67%). Patients in the intubated and nonintubated groups had similar demographic characteristics, and similar American Society of Anesthesiologists physical status and simplified acute physiology score II scores at admission. The intubated group had a significantly lower Pa(O2)/fraction of inspired oxygen (Fi(O2)) ratio (123 +/- 62 mm Hg vs 194 +/- 76 mm Hg, p < 0.01) and more extended bilateral alveolar infiltrates (67% vs 31%, p < 0.01) than the non-intubated group. Within the first NPPV observation period, the Pa(O2)/Fi(O2) increased (+ 36 +/- 29% [+/- SD], p = 0.04) and the respiratory rate decreased (28.2 +/- 3.4 breaths/min vs 23.1 +/- 3.8 breaths/min, p < 0.01) significantly only in the non-intubated group. The non-intubated group had significantly lower length of ICU stay (17.3 +/- 10.9 days vs 34.1 +/- 28.5 days, p < 0.01) and mortality rate (6% vs 29%, p < 0.01). CONCLUSION NPPV may be an alternative to conventional ventilation in selected patients with ARF after abdominal surgery who require ventilatory support.
OBJECTIVE:To compare volume support ventilation (VSV) in which the pressure support level is continuously adjusted to deliver a preset tidal volume, with pressure support ventilation (PSV), in terms of patient behavior and ventilator response when ventilatory demand was increased by addition of dead space to the circuit. DESIGN AND SETTING:Randomized cross-over study in an intensive care unit university hospital. INTERVENTIONS:We assessed in ten patients being weaned off mechanical ventilation the effect of increasing the ventilatory demand by adding a heat-and-moisture exchanger to augment the dead space with a fixed level of PSV and VSV. MEASUREMENTS AND RESULTS:Arterial blood gases, breathing pattern, and respiratory effort parameters at the end of each of the four steps. Adding dead space significantly increased minute ventilation and PaCO2 values with both PSV and VSV. Indexes of respiratory effort (pressure-time index of respiratory muscles and work of breathing) increased with both ventilatory modes after dead-space augmentation. This increase was 2.5-4 times with VSV than with PSV and induced overt respiratory distress in two patients. The assistance delivered during VSV decreased significantly after dead-space augmentation, from 15.0+/-6.5 to 9.1+/-4.8 cmH2O, whereas no change occurred with PSV. CONCLUSIONS:With a fixed level of VSV, but not of PSV, an increase in ventilatory demand results in a decrease in the pressure support provided by the ventilator, opposite to the desired response. VSV may conceivably result in respiratory distress in clinical settings.