All India Institute of Medical Sciences, Jodhpur (AIIMS Jodhpur; IAST: Akhil Bharatiya Aayurvigyan Sansthan Jodhpur) is a medical institute and medical research public university based in Jodhpur, India. It is an Institute of National Importance. Like five other All India Institutes of Medical Sciences (AIIMS), it was established in 2012 and operates autonomously under the Ministry of Health and Family Welfare. The institute is mandated to create excellence in medical education, research and patient care and establish models for affordable and quality healthcare through innovations. AIIMS Jodhpur is also governed under AIIMS Act, 1956.
BACKGROUND:Flexible fibreoptic bronchoscopy (FFB) is widely used in pediatric pulmonology, though hypoxemia remains a primary concern during the procedure. High-flow nasal cannula (HFNC) has shown potential in reducing hypoxemia in adults undergoing FFB. This study evaluates the efficacy and safety of HFNC versus low-flow nasal cannula (LFNC) for preventing hypoxemia during elective FFB in children. METHODS:Children aged 1 month to 18 years scheduled for elective FFB were enrolled, excluding those ineligible for sedation or requiring prior respiratory support. Participants were randomized to HFNC or LFNC groups. The Chi-Square test was used for bivariate analysis; Yates' correction or Fisher's exact test was applied where assumptions were violated. Multivariate analysis was performed to identify clinically significant factors associated with hypoxemia. RESULTS:Of 206 screened children, 122 were randomized (54.1% male; median age 39 months), with 61 in each group. Hypoxemia occurred in 37 (60.66%) HFNC and 34 (55.74%) LFNC patients, with no significant difference (p = 0.59; OR: 0.59-2.53). Complication rates-bradycardia, tachycardia, bradypnea, tachypnea, laryngospasm, and blood pressure changes were similar in both groups. Among those undergoing BAL, hypoxemia did not differ between groups (p = 0.57). No HFNC patient required resuscitation, whereas three LFNC patients developed apnea, interrupting the procedure. Multivariable analysis showed no independent predictors of hypoxemia severity (age, anemia, sedation depth; all p > 0.05). CONCLUSION:HFNC did not show superiority over LFNC in preventing hypoxemia during elective FFB in children, however, the study may have been underpowered to detect modest differences. CLINICAL TRIAL REGISTRATION:Clinical Trials Registry-India (CTRI) Registration No: CTRI/2022/08/044772 Dated: 22-08-2022). URL: https://ctri.nic.in/Clinicaltrials/rmaindet.php?trialid=71295&EncHid=72590.52664&modid=1&compid=19.
INTRODUCTION:Most oral cancers in India present in advanced stages and tend to have poor oncological outcomes. Chemotherapy has been associated with improved oncological outcomes in various cancers, but its role in oral cancer is still not well-defined in curative settings beyond radiosensitisation. Despite an excellent response rate, neoadjuvant chemotherapy trials have failed to show an oncological advantage. Earlier studies were limited by their heterogeneous patient population, including all head and neck subsites, and included both inoperable cancer and early-stage operable cases. Due to such patient selection, the intended results were never met. Patients with biologically aggressive diseases (advanced nodal disease) may derive greater benefit from induction chemotherapy (ICT). Therefore, we aim to determine the oncological advantage of adding ICT to oral squamous cell cancer with advanced nodal disease (N2-N3). METHODS AND ANALYSIS:The study is an open-label, multicentre, randomised controlled trial, with an allocation ratio of 1:1, being conducted at seven leading cancer centres in India. The primary objective is to compare survival outcomes with and without ICT before surgery in patients with oral squamous cell carcinoma (OSCC) and advanced nodal disease, specifically focusing on 2-year disease-free survival (DFS). Secondary objectives include assessing overall survival (OS), clinical and pathological response rates, treatment compliance, treatment completion rates, adverse events, treatment-related toxicity (using Common Terminology Criteria for Adverse Events, V.5.0), quality of life (measured with Functional Assessment of Cancer Therapy-General and Functional Assessment of Cancer Therapy-Head and Neck) and postoperative complications (using the modified Clavien-Dindo classification).The study population consists of patients with operable OSCC and advanced nodal disease (N2-N3), adequate organ function, aged 18-65 years and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2. The treatment arms are the standard arm Surgery arm (SURG), which involves surgery followed by adjuvant radiotherapy with or without concurrent chemotherapy, and the experimental arm (ICT), in which patients will receive two cycles of ICT using either cisplatin, docetaxel and 5-fluorouracil or cisplatin, docetaxel and capecitabine, followed by surgery and adjuvant radiotherapy with or without concurrent chemotherapy. The sample size was calculated to detect an HR of 0.67 with 80% power. A total of 184 events are required, and with an accrual rate of 15 patients per month, 300 patients will be recruited. DFS analysis will occur 32 months after the trial begins, and follow-up will continue for 5 years. OS analysis will be conducted when 184 deaths are observed. Taking 10% of the withdrawal of consent, a total of 346 patients need to be included. ETHICS AND DISSEMINATION:This trial aims to establish the potential superiority of ICT or definitively determine its futility in OSCC with advanced nodal disease. A positive outcome could provide practice-changing data, particularly for Indian patients, whereas negative results could halt the use of ICT in this setting, directing research efforts towards more effective treatment strategies. TRIAL REGISTRATION NUMBER:CTRI/2024/03/064586; NCT06737822; Institutional Ethics Committee (IEC) number: AIIMS/IEC/2023/4622 (lead site).
