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

Not Applicable

• Conditions: Gastric Cancer; Gastric Ulcer; Intestinal Polyps; Intestinal Cancer
• Interventions: Device: High-flow nasal oxygenation combined with nasopharyngeal airway; Device: Regular nasal cannula combined with nasopharyngeal airway

• Registration Number: NCT05526339
• Lead Sponsor: RenJi Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-31
• Study First Submitted QC: 2022-08-31
• Last Update Submitted: 2022-08-31
• Study Start: 2022-09
• Study First Posted: 2022-09-02
• Last Update Posted: 2022-09-02
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Patients receiving selective combined upper intestinal and lower intestinal endoscopy procedure under deep sedation.
2. Age ranging from 19 to 80, both male and female
3. Obese patients，BMI ≥ 28kg/m^2
4. ASA I~III
5. Patients should clearly understand and voluntarily participate in the study, with signed informed consent.

Exclusion Criteria

1. Patients with acute respiratory infection in the last 2 weeks
2. Patients with nasal congestion, epistaxis, recent nasal trauma, recent nasal surgery
3. hypoxia, defined as oxygen saturation measured by pulse oximetry (SpO2) ≤ 95% before preoxygenation.
4. Common advanced gastrointestinal endoscopy procedures meeting eligibility criteria included cholangiopancreatography, endoscopic ultrasound procedures, endoscopic mucosal resection and endoscopic retrograde cholangiopancreatography (ERCP) procedures.
5. coagulation disorders or platelets < 100*10^9/L
6. 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
7. Allergy to eggs, soy products, opioids and other drugs, propofol, etc.
8. Participated in other clinical trials as a subject within 3 months
9. 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.
10. Emergency procedure
11. Pregnant or breast-feeding women
12. Patients having procedures with planned tracheal intubation or laryngeal mask
13. Investigator considers the patients are inappropriate to participate in this trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-flow nasal oxygenation combined with nasopharyngeal airway	High-flow nasal oxygenation combined with nasopharyngeal airway	High-flow nasal oxygenation combined with nasopharyngeal airway was used in obese patients who are scheduled to undergo gastrointestinal endoscopy procedures sedated with propofol.
Regular nasal cannula combined with nasopharyngeal airway	Regular nasal cannula combined with nasopharyngeal airway	Regular nasal cannula combined with nasopharyngeal airway was used in obese patients who are scheduled to undergo gastrointestinal endoscopy procedures sedated with propofol.

Primary Outcome Measures

Name	Time	Method
The incidence of hypoxia	Patients will be followed for the duration of hospital stay, an expected average of 2 hours	Hypoxia refers to 75%≤SpO2\<90%,\<60S

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Second Hospital Affiliated to Soochow University; 🇨🇳 Suzhou, Jiangsu, China

Dushu Lake Hospital Affiliated to Soochow University; 🇨🇳 Suzhou, Jiangsu, China