High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Gastroscopy Sedated by Propofol

NCT ID: NCT03332433

Last Updated: 2018-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2034 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-10
• Study Completion Date: 2018-03-30

Brief Summary

Hypoxia is the most common adverse events during sedated gastroscopy. In present study, high-flow nasal cannula oxygenation will be utilized in order to reduce the hypoxia. At the same time the feasibility and safety will be evaluated.

Conditions

Hypoxia; Gastric Cancer; Esophagus Cancer; Adverse Event

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control group

Oxygen(2L/min) supplied with nasal catheter

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

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

Eligibility Criteria

Inclusion Criteria

• patients undergoing gastroscope
• age over 18 years old
• Signed informed consent form

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 hemodynamic 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 >III;
• Mouth, nose, or throat infection;
• Fever, defined as core body temperature > 37.5oC ;
• Pregnancy, breastfeeding or positive pregnancy test
• Emergency procedure

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Pudong New Area People's Hospital

OTHER

Sponsor Role: collaborator

Shanghai Tongji Hospital, Tongji University School of Medicine

OTHER

Sponsor Role: collaborator

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

diansan su

Vice Chair of the Department of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, China

Renji hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Shanghai Pudong New Area People's Hospital

Shanghai, Shanghai Municipality, China

Countries

China

References

Lin Y, Zhang X, Li L, Wei M, Zhao B, Wang X, Pan Z, Tian J, Yu W, Su D. High-flow nasal cannula oxygen therapy and hypoxia during gastroscopy with propofol sedation: a randomized multicenter clinical trial. Gastrointest Endosc. 2019 Oct;90(4):591-601. doi: 10.1016/j.gie.2019.06.033. Epub 2019 Jul 3.

Reference Type: DERIVED

PMID: 31278907 (View on PubMed)

Other Identifiers

RenJiH-20170724

Identifier Type: -

Identifier Source: org_study_id