HFNO Combined With NPA Reduces Hypoxia During Sedated Gastrointestinal Endoscopy In Obese Patients

Study Overview
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Brief Summary
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Obesity is associated with adverse airway events including desaturation during deep sedation. Previous studies have suggested that high-flow nasal oxygenation may be superior to regular (low-flow) nasal cannula for prevention of hypoxia during Sedated Gastrointestinal Endoscopy in non-obesity patients. The prerequisite of high-flow nasal oxygenation is keeping airway patency. Our pervious study demonstrated that nasopharyngeal airway has the similar efficacy of jaw-lift. In present study we aimed to determine whether high-flow nasal oxygenation combined with nasopharyngeal airway could reduce the incidence of hypoxia during Sedated Gastrointestinal Endoscopy in obese patients.

Official Title
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High-Flow Nasal Oxygenation Combined With Nasopharyngeal Airway Reduces The Incidence Of Hypoxia During Gastrointestinal Endoscopy Sedated With Propofol In Obese Patients: A Prospective, Randomized Clinical Trial

Conditions
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Gastric Cancer, Gastric Ulcer, Intestinal Cancer, Intestinal Polyps

Intervention / Treatment
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* Device: High-flow nasal oxygenation combined with nasopharyngeal airway
* Device: Regular nasal cannula combined with nasopharyngeal airway


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients receiving selective combined upper intestinal and lower intestinal endoscopy procedure under deep sedation. Age ranging from 19 to 80, both male and female Obese patients，BMI ≥ 28kg/m^2 ASA I III Patients should clearly understand and voluntarily participate in the study, with signed informed consent. Exclusion Criteria: Patients with acute respiratory infection in the last 2 weeks Patients with nasal congestion, epistaxis, recent nasal trauma, recent nasal surgery hypoxia, defined as oxygen saturation measured by pulse oximetry (SpO2) ≤ 95% before preoxygenation. Common advanced gastrointestinal endoscopy procedures meeting eligibility criteria included cholangiopancreatography, endoscopic ultrasound procedures, endoscopic mucosal resection and endoscopic retrograde cholangiopancreatography (ERCP) procedures. coagulation disorders or platelets < 100*10^9/L Have serious heart diseases such as severe arrhythmia, heart failure, Adams Stokes Disease, unstable angina pectoris, myocardial infarction in the last 6 months, history of tachycardia / bradycardia requiring medical treatment, third degree atrioventricular block or QTC interval ≥ 450ms (corrected according to fridericia's formula), or exercise tolerance < 4mets Allergy to eggs, soy products, opioids and other drugs, propofol, etc. Participated in other clinical trials as a subject within 3 months Patients with brain injury, possible convulsion, myoclonus, intracranial hypertension, cerebral aneurysm, cerebrovascular accident history, schizophrenia, intellectual disability, mania, psychosis, long-term use of psychotropic drugs, drug addiction, cognitive dysfunction history, etc. Emergency procedure Pregnant or breast-feeding women Patients having procedures with planned tracheal intubation or laryngeal mask Investigator considers the patients are inappropriate to participate in this trial

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-flow nasal oxygenation combined with nasopharyngeal airway<br>High-flow nasal oxygenation combined with nasopharyngeal airway was used in obese patients who are scheduled to undergo gastrointestinal endoscopy procedures sedated with propofol. | Device: High-flow nasal oxygenation combined with nasopharyngeal airway<br>* The patients receive an oxygen flow of 30 L/min for preoxygenation with a high-flow oxygenation device before losing of conscious. At the time of the abolition of the eyelash reflex, the gas flow was increased to 60 L/min with an inspired oxygen fraction 100% and the nasopharyngeal airway was placed.<br>|
| Active Comparator: Regular nasal cannula combined with nasopharyngeal airway<br>Regular nasal cannula combined with nasopharyngeal airway was used in obese patients who are scheduled to undergo gastrointestinal endoscopy procedures sedated with propofol. | Device: Regular nasal cannula combined with nasopharyngeal airway<br>* The patients receive an oxygen flow of 6 L/min for preoxygenation with a regular nasal cannula until the end of procedure. At the time of abolition of the eyelash reflex, the nasopharyngeal airway was placed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of hypoxia | Hypoxia refers to 75%≤SpO2<90%,<60S | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of severe hypoxia | Severe hypoxia refers to SpO2<75% lasting for any time, or 75%≤SpO2<90%, ≥60s | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | 
| The incidence of subclinical respiratory depression | Subclinical respiratory depression refers to 90%≤ SpO2<95% | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | 
| The incidence of other adverse events | Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High-flow nasal oxygenation, Gastrointestinal endoscopy, Hypoxia