Efficacy of High-flow Nasal Oxygen in Preventing Hypoxia... | NCT06710613

Studies
Efficacy of High-flow Nasal Oxygen in Preventing Hypoxia During Gastrointestinal Endoscopy: a Retrospective Cohort Study

NCT06710613

Sponsor

Fengli Liu

Status

Active, not recruiting

Last Update Posted

Dec 16, 2024Actual

Enrollment

900Estimated

Phase

Not provided

Conditions

Hypoxia

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2024Actual

Primary Completion Date

Jun 1, 2025Estimated

Completion Date

Jun 1, 2025Estimated

First Submitted Date

Nov 23, 2024

First Submission Date that Met QC Criteria

Nov 26, 2024

First Posted Date

Nov 29, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2024

Last Update Posted Date

Dec 16, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

During painless gastroscopy, the occurrence of hypoxia is a critical concern, especially under intravenous anesthesia using propofol. This study aimed to investigate the incidence of hypoxia during painless gastroscopy and evaluate preventive measures.

Detailed Description

From June 15 th 2023 to August 15th 2023, 900 patients who underwent elective gastroscopy in the Renji Hospital, Shanghai Jiao Tong University School of Medicine were selected. They were divided into the high flow nasal cannula oxygen group and the conventional nasal cannula oxygen group by oxygen inhalation. Patient demographics, Mallampati class, and other relevant factors were compared between the two groups. Primary outcomes included the incidence hypoxia (SpO2 < 90%), while secondary outcomes included subclinical respiratory depression, and adverse events related to nasal oxygen cannula.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

900Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control group		conventional nasal cannula oxygen group
experimental group		high flow nasal cannula oxygen group

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of hypoxia	SpO2 levels less than 90%	60 seconds

Secondary Outcomes

Measure	Description	Time Frame
the incidence of subclinical respiratory depression and adverse events	the incidence of and subclinical respiratory depression (SpO2 levels between 90% and less than 95%) and adverse events(mouth or nasal dryness, headache, nasal mucosal injury with bleeding, barotrauma. )	30 minute

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria：

Patients aged 18 to 70
Undergoing painless gastroscopy under intravenous anesthesia

Exclusion Criteria：

Severe respiratory disease
History of nasal bleeding or mucosal injury
Emergency cases
Pregnant or lactating female

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

The patients who underwent painless gastroscopy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fengli Liu, master	Nanchang University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nanchang University		Nanchang	Jiangxi	330000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000860	Hypoxia

Ancestor Terms

ID	Term
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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