NCT04212182

Brief Summary

Although non-invasive positive pressure ventilation (NPPV) shows the good curative effect of treating the patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD), some patients do not tolerate NPPV or do not benefit from it. High-flow nasal cannula (HFNC) is well tolerated and may be used to patients with AECOPD who are intolerant to NPPV treatment. This study is to evaluate the physiological effect of HFNC and compare it with NPPV.

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 Dec 2019

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

December 23, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 26, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

December 27, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

December 30, 2019

Status Verified

December 1, 2019

Enrollment Period

6 months

First QC Date

December 23, 2019

Last Update Submit

December 26, 2019

Conditions

High-flow Nasal CannulaNon-invasive Positive Pressure VentilationAcute Exacerbation of Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • Neural respiratory drive

    Neural respiratory drive is calculated by diaphragm electromyogram

    30 minutes

Secondary Outcomes (2)

  • Work of breathing

    30 minutes

  • Transcutaneous CO2

    30 minutes

Study Arms (2)

HFNC group

EXPERIMENTAL

AECOPD patients receive ventilation support via HFNC.

Device: HFNC

NPPV group

ACTIVE COMPARATOR

AECOPD patients receive ventilation support via NPPV.

Device: NPPV

Interventions

HFNCDEVICE

HFNC provides warmed and humidified gas administered through slightly enlarged nasal prongs.

HFNC group
NPPVDEVICE

NPPV is the standard therapy for ventilatory failure in AECOPD.

NPPV group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • AECOPD patients with acute hypercapnic respiratory failure

You may not qualify if:

  • other lung/pleural diseases or thoracic deformity
  • severe heart failure (New York Heart Association class IV), severe dysrhythmia
  • unstable angina, or malignant comorbidity
  • obesity (BMI ≥ 35 kg/m²)
  • severe obstructive sleep apnea syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University.

Guangzhou, Guangdong, 510120, China

RECRUITING

Study Officials

  • Rongchang Chen, MD

    The First Affiliated Hospital of Guangzhou Medical University

    STUDY CHAIR

Central Study Contacts

Lili Guan, PhD

CONTACT

+8613422288665dr_nickguan@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 23, 2019

First Posted

December 26, 2019

Study Start

December 27, 2019

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

December 30, 2019

Record last verified: 2019-12

Locations

CN(1)