NCT04840628

Brief Summary

To investigate the relation the nreural drive and intrinsic positive end-expiratory pressure(PEEPi) of the chronic obstructive pulmonary disease(COPD) patients with respiratory failure.In present study the PEEPi of COPD patients was increased by increasing the resistance of the respiratory system, the change of the neural drive was recorded.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

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

November 20, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 12, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2021

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2021

Completed
Last Updated

February 7, 2022

Status Verified

February 1, 2022

Enrollment Period

7 months

First QC Date

November 27, 2020

Last Update Submit

February 4, 2022

Conditions

Keywords

neural respiratory driveIntrinsic Positive End-expiratory PressureChronic Obstructive Pulmonary Disease Patients

Outcome Measures

Primary Outcomes (1)

  • neural respiratory drive assessed by the root mean square of diaphragm electromyogram (EMGdi) of the chronic obstructive pulmonary disease patients with respiratory failure

    neural respiratory drive assessed by the root mean square of diaphragm electromyogram (EMGdi) obtained from the a multi-pair esophageal electrode catheter

    1 hour

Study Arms (1)

neural respiratory drive

EXPERIMENTAL

neural respiratory drive assessed by EMGdi recorded from a multipair esophageal electrode

Other: Resistance of the respiratory system

Interventions

increase the resistance of the respiratory system of the chronic obstructive pulmonary disease patients

neural respiratory drive

Eligibility Criteria

Age50 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic obstructive pulmonary disease patients with respiratory failure

You may not qualify if:

  • Heart failure
  • cardiac dysrhythmia
  • Loss of consciousness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1State Key Laboratory of Respiratory Disease, National clinical research center for respiratory disease, Guangzhou Institute of respiratory health. 2The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 520120, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: the chronic obstructive pulmonary disease patients with respiratory failure
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 27, 2020

First Posted

April 12, 2021

Study Start

November 20, 2020

Primary Completion

June 21, 2021

Study Completion

July 3, 2021

Last Updated

February 7, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

we will share our data by publishing the paper

Locations