NCT03332433

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,034

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

November 10, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

4 months

First QC Date

October 26, 2017

Last Update Submit

September 2, 2018

Conditions

HypoxiaGastric CancerEsophagus CancerAdverse Event

Keywords

HypoxiaGastroscopeHigh-flow nasal cannula

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Incidence of subclinical respiratory depression

    Patients will be followed for the duration of hospital stay, an expected average of 2 hours

  • Incidence of severe hypoxia

    Patients will be followed for the duration of hospital stay, an expected average of 2 hours

  • Other adverse events

    Patients will be followed for the duration of hospital stay, an expected average of 2 hours

Study Arms (2)

Control group

NO INTERVENTION

Oxygen(2L/min) supplied with nasal catheter

High-flow nasal cannula group

EXPERIMENTAL

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

Device: High-flow nasal cannula oxygenation

Interventions

High-flow nasal cannula oxygenationDEVICE

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

High-flow nasal cannula group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, 200065, China

Location

Renji hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200127, China

Location

Shanghai Pudong New Area People's Hospital

Shanghai, Shanghai Municipality, China

Location

Related Publications (1)

  • 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.

    PMID: 31278907DERIVED

MeSH Terms

Conditions

HypoxiaStomach NeoplasmsEsophageal Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesHead and Neck NeoplasmsEsophageal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Chair of the Department of Anesthesiology

Study Record Dates

First Submitted

October 26, 2017

First Posted

November 6, 2017

Study Start

November 10, 2017

Primary Completion

February 28, 2018

Study Completion

March 30, 2018

Last Updated

September 5, 2018

Record last verified: 2018-09

Locations

CN(3)