NCT05510388

Brief Summary

The objective of this study is to observe the preventive effects of high flow nasal oxygenation on the incidence of hypoxia during gastroscopy or colonoscopy sedated with propofol in high-risk patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for not_applicable gastric-cancer

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable gastric-cancer

Geographic Reach
1 country

2 active sites

Status
unknown

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

August 17, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

August 22, 2022

Status Verified

August 1, 2022

Enrollment Period

10 months

First QC Date

August 17, 2022

Last Update Submit

August 18, 2022

Conditions

Gastric CancerIntestinal CancerIntestine AdenomaGastritis

Keywords

GastroscopyHigh-flow nasal oxygenationHypoxiaHigh-riskColonoscopy

Outcome Measures

Primary Outcomes (1)

  • The incidence of hypoxia

    Hypoxia refers to 75%≤SpO2\<90%,\<60S

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

Secondary Outcomes (4)

  • The incidence of severe hypoxia

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

  • The incidence of subclinical respiratory depression

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

  • Other adverse events evaluated by the tool of World SIVA

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

  • Complications related to high-flow nasal cannula

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

Study Arms (2)

High-flow nasal cannula oxygenation group

EXPERIMENTAL
Device: High-flow nasal cannula oxygenation

Regular nasal cannula oxygenation group

ACTIVE COMPARATOR
Device: Regular nasal cannula oxygenation

Interventions

High-flow nasal cannula oxygenationDEVICE

The patients receive oxygen flow of 6L/min for preoxygenation with an high-flow canular oxygenation device before losing of conscious. Then, the oxygen flow is adjusted to 60L/min with the oxygen concentration of 100% and the temperature of 37℃ until the end of procedure.

High-flow nasal cannula oxygenation group
Regular nasal cannula oxygenationDEVICE

The patients receive an oxygen flow of 6L/min for preoxygenation with a disposal regular nasal cannula until the end of procedure.

Regular nasal cannula oxygenation group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ranging from 18 to 80, both sexes
  • Patients receiving selective gastroscopy or colonoscopy or gastroscopy and colonoscopy procedure
  • ASA Ⅲ\~Ⅳ
  • kg/m2\<BMI\<28kg/m2
  • The anticipated operation time of the procedure shall be less than 30min.
  • Patients should clearly understand and voluntarily participate in the study, with signed informed consent.

You may not qualify if:

  • Patients with nasal congestion, epistaxis, recent nasal trauma, recent nasal surgery, increased intracranial pressure and skull fracture, etc. who can not tolerate high-flow nasal cannula.
  • Patients diagnosed POCD
  • Patients clearly identified difficult airway
  • Patients with mechanical ventilation
  • Patients with acute respiratory infection and asthma
  • Patients with acute upper gastrointestinal hemorrhage accompanied by shock, severe anemia, gastrointestinal obstruction accompanied by retention of gastric contents
  • Patients with aortic stenosis and carotid stenosis
  • Patients allergic to sedatives such as propofol
  • Patients without civil capacity such as cognitive dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Second Hospital Affiliated to Chongqing Medical University

Chongqing, Chongqing Municipality, 404100, China

Location

Henan Provincial people's hospital

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Stomach NeoplasmsIntestinal NeoplasmsGastritisHypoxia

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesIntestinal DiseasesGastroenteritisSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Wanfeng Liu

CONTACT

+8613817793010liuwanfeng@renji.com

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
SPONSOR

Study Record Dates

First Submitted

August 17, 2022

First Posted

August 22, 2022

Study Start

September 1, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

August 22, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)