HFNO Reduces Hypoxia During Sedated Gastroscopy or Colonoscopy in High Risk Patients

NCT ID: NCT05510388

Last Updated: 2022-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastric Cancer Intestinal Cancer Intestine Adenoma Gastritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High-flow nasal cannula oxygenation group

Group Type EXPERIMENTAL

High-flow nasal cannula oxygenation

Intervention Type DEVICE

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.

Regular nasal cannula oxygenation group

Group Type ACTIVE_COMPARATOR

Regular nasal cannula oxygenation

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High-flow nasal cannula oxygenation

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.

Intervention Type DEVICE

Regular nasal cannula oxygenation

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age ranging from 18 to 80, both sexes
2. Patients receiving selective gastroscopy or colonoscopy or gastroscopy and colonoscopy procedure
3. ASA Ⅲ\~Ⅳ
4. 18 kg/m2\<BMI\<28kg/m2
5. The anticipated operation time of the procedure shall be less than 30min.
6. Patients should clearly understand and voluntarily participate in the study, with signed informed consent.

Exclusion Criteria

1. 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.
2. Patients diagnosed POCD
3. Patients clearly identified difficult airway
4. Patients with mechanical ventilation
5. Patients with acute respiratory infection and asthma
6. Patients with acute upper gastrointestinal hemorrhage accompanied by shock, severe anemia, gastrointestinal obstruction accompanied by retention of gastric contents
7. Patients with aortic stenosis and carotid stenosis
8. Patients allergic to sedatives such as propofol
9. Patients without civil capacity such as cognitive dysfunction
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Second Hospital Affiliated to Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status

Henan Provincial people's hospital

Zhengzhou, Henan, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Wanfeng Liu

Role: CONTACT

+8613817793010

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

He Huang

Role: primary

Jiaqiang Zhang

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KY2022-116-B

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.