NCT05097560

Brief Summary

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.

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
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 11, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 28, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

October 28, 2021

Status Verified

October 1, 2021

Enrollment Period

10 months

First QC Date

October 16, 2021

Last Update Submit

October 16, 2021

Conditions

Keywords

HFNCPR

Outcome Measures

Primary Outcomes (1)

  • Endurance time

    Endurance time for 10 minute steping test

    10 minute

Secondary Outcomes (3)

  • Respiratory pattern

    10 minute

  • Work of breathing

    10 minute

  • Neural respiratory drive

    10 minute

Study Arms (2)

HFNC group

EXPERIMENTAL

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

Device: high flow nasal cannula

VM group

ACTIVE COMPARATOR

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

Device: Venturi mask

Interventions

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.

HFNC group

VM is commonly used by COPD patients during exercise training.

VM group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • active coronary ischemia
  • respiratory diseases other than COPD
  • unstable vital signs
  • unstable psychological status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiying

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rongchang Chen, PhD

    The First Affiliated Hospital of Guangzhou Medical University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 16, 2021

First Posted

October 28, 2021

Study Start

August 11, 2021

Primary Completion

May 31, 2022

Study Completion

August 31, 2022

Last Updated

October 28, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations