The Effect of HFNC on Exercise Capacity Compared to VM in COPD Patients Recovering From Acute Evacerbation

NCT ID: NCT05097560

Last Updated: 2021-10-28

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-11

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.

Early PR is thought to be effective in COPD patients recovering from acute exacerbation, while the effect of HFNC during exercise training in these patients remains unclear. The study may provide evidence of early PR in COPD patients recovering from acute exacerbation.

Detailed Description

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

We hypothesize that HFNC may increases exercise time in COPD patients recovering from acute exacerbation compare to VM. A randomized, cross-over clinical trial in which either HFNC or VM may be used as an adjunct in 10-MST in random order, respectively, will be performed to compare the endurance time. The physiological effect of HFNC and VM during exercise will also be measured to explore the mechanism.

Conditions

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

COPD

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

HFNC PR

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

HFNC group

* Set FiO2 28%
* Titrate the flow of HFNC at the highest tolerated value up to 60 L/min

Group Type EXPERIMENTAL

high flow nasal cannula

Intervention Type DEVICE

HFNC provides humidified, heated, oxygen-enriched air at constant concentration with a flow up to 60L/min through a nasal cannula. It washouts the anatomical dead space and decreases the work of breathing.

VM group

\- Keep FiO2 constant with VM and HFNC during the two trial

Group Type ACTIVE_COMPARATOR

Venturi mask

Intervention Type DEVICE

VM is commonly used by COPD patients during exercise training.

Interventions

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

high flow nasal cannula

HFNC provides humidified, heated, oxygen-enriched air at constant concentration with a flow up to 60L/min through a nasal cannula. It washouts the anatomical dead space and decreases the work of breathing.

Intervention Type DEVICE

Venturi mask

VM is commonly used by COPD patients during exercise training.

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* hospitalized AECOPD patients
* be ambulatory by 48h after admission for AECOPD
* requires oxygen by screening exercise test

Exclusion Criteria

* active coronary ischemia
* respiratory diseases other than COPD
* unstable vital signs
* unstable psychological status
Minimum Eligible Age

40 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.

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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

Shiying Fang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rongchang Chen, PhD

Role: STUDY_CHAIR

The First Affiliated Hospital of Guangzhou Medical University

Locations

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

Shiying

Guangzhou, Guangdong, China

Site Status RECRUITING

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.

Shiying Fang, MD

Role: CONTACT

Phone: +8602083062882

Email: [email protected]

Facility Contacts

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

Shiying Fang, MD

Role: primary

Rongchang Chen, PhD

Role: backup

Other Identifiers

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

FAHGZ-20210811

Identifier Type: -

Identifier Source: org_study_id