High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Sedated Gastrointestinal Endoscopes in Obesity

Gastric Cancer Clinical Trial

Official title:

High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Sedated Gastrointestinal Endoscopes in Obesity: a Randomized Multicenter Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04500392
• Other study ID #: HFNOIO
• Status: Recruiting
• Phase: N/A
• Start date: May 6, 2021
• Est. completion date: January 2024

Study information

• Verified date: January 2024
• Source: RenJi Hospital
• Contact: Diansan Su, Dr.
• Phone: +862168383702
• Email: diansansu[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hypoxia is the most common adverse event during gastrointestinal endoscopes sedated with propofol and sufentanil, especially in obese people. In the present study, high-flow nasal cannula oxygenation will be utilized in order to reduce the incidence of hypoxia among obesity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• patients undergoing gastrointestinal endoscopes

• age=18 years old and =70 years old

• patients or family members signed informed consent form

• ASA classification I-II

• BMI= 28kg/m²

Exclusion Criteria:

• Coagulation disorders or a tendency of nose bleeding;

• An episode/exacerbation of congestive heart failure (CHF) that requires a change in medication, diet or hospitalization from any cause in the last 6 months;

• Severe aortic stenosis or mitral stenosis;

• Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months;

• Acute myocardial infarction in the last 6 months;

• Acute arrhythmia (including any tachycardia - or bradycardia) with the fluid of hemodynamics instability;

• Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy);

• Increased intracranial pressure;

• ASA classification ?-? ;

• Mouth, nose, or throat infection;

• Liver and kidney disease

• Fever, defined as core body temperature > 37.5?;

• Pregnancy, breastfeeding or positive pregnancy test;

• Emergency procedure;

• Patients or family members refused to participate

• Mental disorders and people without civil capacity

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Polyps
• Esophageal Neoplasms
• Esophagus Cancer
• Gastric Cancer
• Hypoxia
• Polyp of Colon

Intervention

Device:
• High-flow nasal cannula oxygenation
Oxygen is supplied with a high-flow nasal cannula oxygenation device#the flow is up to 60L/min
• Regular nasal cannula
Oxygen is supplied with a regular nasal cannula #the flow is up to 6L/min

Locations

Country	Name	City	State
China	Renji hospital, School of Medicine, Shanghai Jiaotong University	Shanghai	Shanghai, China
China	Shanghai Oriental Hospital	Shanghai	Shanghai, China
China	Shanghai Tongji Hospital	Shanghai	Shanghai, China

Sponsors (3)

Lead Sponsor	Collaborator
RenJi Hospital	Shanghai Oriental Hospital, Tongji University School of Medicine, Shanghai Tongji Hospital, Tongji University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of hypoxia	(75% = SpO2 < 90% for <60 s)	Patients will be followed for the duration of hospital stay, an expected average of 2 hours]
Secondary	The incidence of subclinical respiratory depression	(90% = SpO2 < 95%)	Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary	The incidence of severe hypoxia	(SpO2 < 75% for any duration or 75% < SpO2 < 90% for >/=60 s)	Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary	Other adverse events include other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force and HFNC supportive oxygen therapy-related adverse events.		Patients will be followed for the duration of hospital stay, an expected average of 2 hours