MedDataX Logo

The 90% Effective Flow of High Flow Nasal Oxygenation (HFNO) During Sedated Bronchoscopy

NCT ID: NCT05298319

Last Updated: 2023-11-29

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

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-08-31

Brief Summary

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

Patients undergoing sedated bronchoscopy were randomized into six groups (10 Liters/minute \[L/min\], 20 L/min, 30 L/min, 40 L/min, 50 L/min, 60 L/min). The primary outcome was the incidence of hypoxemia.

Detailed Description

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

It's a double-blind, randomized trial. The patients'demographic information, such as sex, weight, height, smoking status, present illness and history of past illness, were collected. After successful peripheral intravenous access, all patients, before sedation, received 20 min nebulization with lidocaine via a nebuliser facemask. The basic oxygen saturation, heart rate, and blood pressure of the patients were recorded by the investigators.Patients in the HFNO group received humidified oxygen at different rates via a high-flow nasal cannula (AIRVO2, New Zealand). After sedation with propofol and sufentanil, continuous electrocardiography and pulse oximetry were recorded, and the blood pressure of the patients was monitored throughout the procedure. . After bronchoscopy, patients were transferred to the post anesthesia care unit (PACU) if their vital signs were stable.

Conditions

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

Hypoxia

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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

Group 1

10 L/min of oxygen flow

Group Type EXPERIMENTAL

high flow nasal cannula

Intervention Type DEVICE

The patients were randomized into 6 groups, each group received different flow of oxygen, to observe the incidence of hypoxemia between different groups.

Group 2

20 L/min of oxygen flow

Group Type EXPERIMENTAL

high flow nasal cannula

Intervention Type DEVICE

The patients were randomized into 6 groups, each group received different flow of oxygen, to observe the incidence of hypoxemia between different groups.

Group 3

30 L/min of oxygen flow

Group Type EXPERIMENTAL

high flow nasal cannula

Intervention Type DEVICE

The patients were randomized into 6 groups, each group received different flow of oxygen, to observe the incidence of hypoxemia between different groups.

Group 4

40 L/min of oxygen flow

Group Type EXPERIMENTAL

high flow nasal cannula

Intervention Type DEVICE

The patients were randomized into 6 groups, each group received different flow of oxygen, to observe the incidence of hypoxemia between different groups.

Group 5

50 L/min of oxygen flow

Group Type EXPERIMENTAL

high flow nasal cannula

Intervention Type DEVICE

The patients were randomized into 6 groups, each group received different flow of oxygen, to observe the incidence of hypoxemia between different groups.

Group 6

60 L/min of oxygen flow

Group Type EXPERIMENTAL

high flow nasal cannula

Intervention Type DEVICE

The patients were randomized into 6 groups, each group received different flow of oxygen, to observe the incidence of hypoxemia between different groups.

Interventions

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

high flow nasal cannula

The patients were randomized into 6 groups, each group received different flow of oxygen, to observe the incidence of hypoxemia between different groups.

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) undergoing sedated bronchoscopy
* (2) 18 to 70 years of age;
* (3) American Society of Anaesthesiologists (ASA) class: I-III

Exclusion Criteria

* (1) severe cardiac disease, including aortic stenosis, mitral stenosis, hemodynamic instability caused by severe arrhythmia, and acute myocardial infarction or cardiac surgery within the last 6 months;
* (2) severe hypoxemia (SpO2 \< 90% without oxygen supply on admission), caused by interstitial lung disease, end-stage chronic obstructive pulmonary disease (COPD) or other diseases;
* (3) upper respiratory tract infection or lung infection;
* (4) refusal to participate in this study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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

Wen Zhang

attending, principle investigator, department of anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status

Countries

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

China

References

Explore related publications, articles, or registry entries linked to this study.

Zhang W, Yuan X, Shen Y, Wang J, Xie K, Chen X. Optimal flow of high-flow nasal cannula oxygenation to prevent desaturation during sedation for bronchoscopy: a randomized controlled study. Ther Adv Respir Dis. 2024 Jan-Dec;18:17534666241246637. doi: 10.1177/17534666241246637.

Reference Type DERIVED
PMID: 38659187 (View on PubMed)

Other Identifiers

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

Zhejiang Cancer Hospital

Identifier Type: -

Identifier Source: org_study_id