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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04500392
Enrollment
1000
Registered
2020-08-05
Start date
2021-05-06
Completion date
2024-01-31
Last updated
2024-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer, Esophagus Cancer, Gastric Cancer, Hypoxia, Polyp of Colon

Keywords

Hypoxia, Gastrointestinal endoscopes, High-flow nasal cannula Oxygenation

Brief 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.

Interventions

Oxygen is supplied with a high-flow nasal cannula oxygenation device#the flow is up to 60L/min

Oxygen is supplied with a regular nasal cannula #the flow is up to 6L/min

Sponsors

Shanghai Tongji Hospital, Tongji University School of Medicine
CollaboratorOTHER
Shanghai Oriental Hospital, Tongji University School of Medicine
CollaboratorUNKNOWN
RenJi Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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 Ⅲ-Ⅳ ; * 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

Design outcomes

Primary

MeasureTime frameDescription
The incidence of hypoxiaPatients will be followed for the duration of hospital stay, an expected average of 2 hours](75% ≤ SpO2 \< 90% for \<60 s)

Secondary

MeasureTime frameDescription
The incidence of subclinical respiratory depressionPatients will be followed for the duration of hospital stay, an expected average of 2 hours(90% ≤ SpO2 \< 95%)
The incidence of severe hypoxiaPatients will be followed for the duration of hospital stay, an expected average of 2 hours(SpO2 \< 75% for any duration or 75% \< SpO2 \< 90% for \>/=60 s)
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

Countries

China

Contacts

Primary ContactDiansan Su, Dr.
diansansu@yahoo.com+862168383702

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026