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

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

NCT ID: NCT05526339

Condition: Gastric Cancer
Gastric Ulcer
Intestinal Cancer
Intestinal Polyps

Conditions: Official terms:
Intestinal Neoplasms
Stomach Ulcer
Hypoxia
Intestinal Polyps

Conditions: Keywords:
High-flow nasal oxygenation
Gastrointestinal endoscopy
Hypoxia

Study type: Interventional

Study phase: N/A

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: High-flow nasal oxygenation combined with nasopharyngeal airway
Description: 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.
Arm group label: High-flow nasal oxygenation combined with nasopharyngeal airway

Intervention type: Device
Intervention name: Regular nasal cannula combined with nasopharyngeal airway
Description: 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.
Arm group label: Regular nasal cannula combined with nasopharyngeal airway

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.

Criteria for 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

Gender: All

Minimum age: 19 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Dushu Lake Hospital Affiliated to Soochow University

Address:
City: Suzhou
Zip: 215000
Country: China

Facility:
Name: Second Hospital Affiliated to Soochow University

Address:
City: Suzhou
Zip: 215000
Country: China

Contact:
Last name: Jiang Zhu

Start date: September 2022

Completion date: May 2024

Lead sponsor:
Agency: RenJi Hospital
Agency class: Other

Collaborator:
Agency: Second Affiliated Hospital of Soochow University
Agency class: Other

Collaborator:
Agency: Dushu Lake Hospital Affiliated to Soochow University
Agency class: Other

Source: RenJi Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05526339