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

NCT ID: NCT04500392

Last Updated: 2024-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-06

Study Completion Date

2024-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypoxia Gastric Cancer Esophagus Cancer Polyp of Colon Colon Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

Oxygen(up to 6L/min) supplied with a regular nasal catheter

Group Type ACTIVE_COMPARATOR

Regular nasal cannula

Intervention Type DEVICE

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

High-flow nasal cannula group

Oxygen(up to 60L/min) supplied with high-flow nasal cannula

Group Type EXPERIMENTAL

High-flow nasal cannula oxygenation

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High-flow nasal cannula oxygenation

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

Intervention Type DEVICE

Regular nasal cannula

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shanghai Tongji Hospital, Tongji University School of Medicine

OTHER

Sponsor Role collaborator

Shanghai Oriental Hospital, Tongji University School of Medicine

UNKNOWN

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

diansan su

Vice Chair of the Department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Diansan Su, Dr.

Role: PRINCIPAL_INVESTIGATOR

Renji Hospital, Shanghai Jiaotong University, Shanghai, China

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shanghai Tongji Hospital

Shanghai, Shanghai, China, China

Site Status RECRUITING

Shanghai Oriental Hospital

Shanghai, Shanghai, China, China

Site Status RECRUITING

Renji hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai, China, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Diansan Su, Dr.

Role: CONTACT

+862168383702

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Xiaoqing Zhang, M.S.

Role: primary

Xiangrui Wang, Dr.

Role: primary

Zhang Yuanyuan, B.S.

Role: primary

+862168383702

References

Explore related publications, articles, or registry entries linked to this study.

Wang L, Zhang Y, Han D, Wei M, Zhang J, Cheng X, Zhang Y, Shi M, Song Z, Wang X, Zhang X, Su D. Effect of high flow nasal cannula oxygenation on incidence of hypoxia during sedated gastrointestinal endoscopy in patients with obesity: multicentre randomised controlled trial. BMJ. 2025 Feb 11;388:e080795. doi: 10.1136/bmj-2024-080795.

Reference Type DERIVED
PMID: 39933757 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HFNOIO

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.