Background: Hypoxia is an extremely common adverse event occurring during a sedated gastrointestinal endoscopy procedure, especially in elderly patients, because of the limited reservation. Prolonged or severe hypoxia can cause ischemia of coronary artery, permanent nervous system damage, or even result in death. Hence, it is extremely important to reduce or prevent hypoxia during sedated gastrointestinal endoscopy in elderly patients. Although several oxygen methods would reduce hypoxia during this procedure, early detection of respiratory depression and early administration of intervention would be the best method to reduce or even confirm the hypoxia. Capnographic monitoring is found to be more sensitive to respiratory depression in patients before the onset of hypoxia than the current clinical routine monitoring of pulse oxygen saturation (SpO 2 ); however, there exists a controversy regarding its effect. Therefore, this study was designed to improve the security of sedated gastrointestinal endoscopy in elderly patients.
Methods: A multicenter, randomized, single-blind, two-arm parallel-group, controlled with active comparator, interventional clinical trial will be conducted to evaluate the impact of an intervention based on additional capnographic monitoring on the incidence of hypoxia in elderly patients. Patients (n = 1800) scheduled for gastrointestinal endoscopy with propofol sedation will be randomly assigned to either a control arm with standard monitoring or an interventional arm in which additional capnographic monitoring is available.
Discussion: This research project is primarily intended to examine whether an intervention based on additional capnographic monitoring would reduce the incidence of hypoxia in elderly patients during propofol and sufentanil sedation for gastrointestinal endoscopy. The results of this study may have a extensive impact on sedated gastrointestinal endoscopy practice and the development of guidelines.
Trial registration: ClinicalTrials.gov, NCT05030870. Registered on September 1, 2021.