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

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05526339
• Other study ID #: LY2022-018-A
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: May 2024

Study information

• Verified date: August 2022
• Source: RenJi Hospital
• Contact: Diansan Su
• Phone: +8618616514088
• Email: diansansu[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Gastric Ulcer
• Hypoxia
• Intestinal Cancer
• Intestinal Neoplasms
• Intestinal Polyps
• Stomach Ulcer

Intervention

Device:
• High-flow nasal oxygenation combined with nasopharyngeal airway
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.
• Regular nasal cannula combined with nasopharyngeal airway
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.

Locations

Country	Name	City	State
China	Dushu Lake Hospital Affiliated to Soochow University	Suzhou	Jiangsu
China	Second Hospital Affiliated to Soochow University	Suzhou	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
RenJi Hospital	Dushu Lake Hospital Affiliated to Soochow University, Second Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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