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

High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Gastroscopy Sedated by Propofol: a Randomized Multicentre Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Hypoxia; Gastric Cancer; Adverse Event; Esophagus Cancer
• Intervention / Treatment: Device: High-flow nasal cannula oxygenation

• Study Type: Interventional
• Enrollment (Actual): 2034
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200065
      • Shanghai Tongji Hospital
    • Shanghai, Shanghai, China, 200127
      • Renji Hospital, School of Medicine, Shanghai Jiaotong University
    • Shanghai, Shanghai, China
      • Shanghai Pudong New Area People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Oxygen(2L/min) supplied with nasal catheter
Experimental: High-flow nasal cannula group; Oxygen(up to 60L/min) supplied with high-flow nasal cannula	Device: High-flow nasal cannula oxygenation; Oxygen is supplied with a high-flow nasal cannula oxygenation device，the flow is up to 60L/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of subclinical respiratory depression	(90% ≤ SpO2 < 95%)	Patients will be followed for the duration of hospital stay, an expected average of 2 hours
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
Other adverse events	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

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Collaborators: Shanghai Tongji Hospital, Tongji University School of Medicine; Shanghai Pudong New Area People's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2017
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): March 30, 2018

Study Registration Dates

• First Submitted: October 26, 2017
• First Submitted That Met QC Criteria: November 1, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): September 5, 2018
• Last Update Submitted That Met QC Criteria: September 2, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Hypoxia; High-flow nasal cannula; Gastroscope
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Signs and Symptoms, Respiratory; Esophageal Diseases; Hypoxia; Esophageal Neoplasms
• Other Study ID Numbers: RenJiH-20170724

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No