Clinical trial NCT05526339: HFNO Combined With NPA Reduces Hypoxia During Sedated Gastrointestinal Endoscopy In Obese Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
Gastric Ulcer
Intestinal Cancer
Intestinal Polyps
Keywords: High-flow nasal oxygenation
Gastrointestinal endoscopy
Hypoxia
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital of Soochow University
name: Dushu Lake Hospital Affiliated to Soochow University
First posted: 2022-09-02
Enrollment: 600
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: The incidence of hypoxia
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary outcomes:
measure: The incidence of severe hypoxia
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
measure: The incidence of subclinical respiratory depression
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
measure: The incidence of other adverse events
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Dushu Lake Hospital Affiliated to Soochow University
state: Jiangsu
city: Suzhou
country: China
facility: Second Hospital Affiliated to Soochow University
state: Jiangsu
Study officials:
affiliation: RenJi Hospital
name: Diansan Su
role: PRINCIPAL_INVESTIGATOR
References: