The effects of nasopharyngeal airway on hypoxemia in painless gastrointestinal endoscopy in obese outpatients: study protocol for a randomized controlled trial
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Introduction : The combination of propofol and opioids is widely used for anesthesia induction and procedural sedation in clinical practice. Despite the advantages of quick onset, good sedative effect, short maintenance and recovery time, hypoxemia (peripheral blood oxygen saturation, SpO 2 < 90%) occurs frequently in obese patients (body mass index ≥ 28 kg/m 2 ) undergoing painless gastrointestinal endoscopy. The primary aim of this study is to investigate the effects of the nasopharyngeal airway on alleviating hypoxemia of obese outpatients during this examination. Methods : This is a prospective single-center randomized controlled study. After signing the written informed consent, eligible outpatients scheduled for painless gastrointestinal endoscopy will be randomly allocated into the nasopharyngeal airway group (group N) and control group (group C), with 88 patients in each group. Patients in group N will be inserted the nasopharyngeal airway before examination, while patients in group C will not. All patients will receive propofol and opioids for procedural sedation. The primary outcome will be the incidence of hypoxemia. The secondary outcomes will be the incidence of epistaxis, suspended examination due to hypoxemia, manual ventilation, the times of attempt to nasopharynx airway insertion, duration of insertion nasopharyngeal airway, tracheal/laryngeal mask intubation, adverse cardiovascular events, gastrointestinal complications, VAS score of nasopharynx pain after removing the nasopharynx airway, satisfaction score of patients, endoscopist and anesthesiologists. Discussion : This study evaluates the effects of nasopharyngeal airway insertion on sedation-caused hypoxemia for obese patients undergoing gastrointestinal endoscopy. The results of this study is expected to provide evidence for the use of nasopharyngeal airway in obese outpatients. Ethics : The study was approved by the Medical Ethics Committee of Deyang People’s Hospital on November 21, 2023 (Ethics Number: 2023-03-024-K01). Trial registration number : ChiCTR2300078892.
