Intubation of obese patients in the operating room with or without bag-mask ventilation: study protocol for a randomized multicenter trial (VENT OR NOT)

Background Almost two-thirds of the adults in Europe are overweight or obese. Obese patients are at higher risk of complications, especially during intubation. Therefore, the management of general anesthesia is crucial. Regarding intubation, there is no consensus among anesthesiologists between the two strategies: standard sequence intubation (i.e., with bag-mask ventilation between induction and intubation) vs. rapid sequence intubation (i.e., without bag-mask ventilation between induction and intubation) assuming that these patients are at high risk of inhalation and desaturation during apnea. This study aims to compare the incidence of intubation-related complications between these two strategies in severely obese patients undergoing elective surgery. Methods The VENT OR NOT study is a prospective, multicenter, open-label, randomized trial including obese patients with a Body Mass Index ≥ 35 kg/m ² requiring tracheal intubation before scheduled surgery. We will assess the superiority of the standard sequence intubation (“VENT strategy”) compared with the rapid sequence intubation (“NO VENT strategy”) to prevent intubation-related complications in 702 obese patients. Enrolment started in September 2023 in 13 French academic and non-academic hospitals and is expected to finish in September 2025. The primary outcome is a composite outcome of complications occurring from the induction of general anesthesia up to 10 min after intubation including: oxygen desaturation < 95%, intubation failure on the first attempt, aspiration or regurgitation, and severe hypotension, defined as a systolic blood pressure < 80 mmHg. The VENT OR NOT trial began after Ethics Committee approval has been obtained and is carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. Discussion The VENT OR NOT trial is the first randomized controlled trial designed to investigate whether the “VENT strategy” reduces the risk of intubation-related complications compared with the “NO VENT strategy” for elective surgery. Trial registration: ClinicalTrials.gov (NCT05930678), registered on June 1, 2023.