The Relationship Between the Neural Drive and Intrinsic Positive End-expiratory Pressure
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Resistance of the respiratory system
Sponsored by

About this trial
This is an interventional other trial for Chronic Obstructive Pulmonary Disease focused on measuring neural respiratory drive, Intrinsic Positive End-expiratory Pressure, Chronic Obstructive Pulmonary Disease Patients
Eligibility Criteria
Inclusion Criteria:
chronic obstructive pulmonary disease patients with respiratory failure
Exclusion Criteria:
- Heart failure
- cardiac dysrhythmia
- Loss of consciousness
Sites / Locations
- 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
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
neural respiratory drive
Arm Description
neural respiratory drive assessed by EMGdi recorded from a multipair esophageal electrode
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04840628
First Posted
November 27, 2020
Last Updated
February 4, 2022
Sponsor
The First Affiliated Hospital of Guangzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04840628
Brief Title
The Relationship Between the Neural Drive and Intrinsic Positive End-expiratory Pressure
Official Title
The Relationship Between the Nreural Drive and Intrinsic Positive End-expiratory Pressure of the Chronic Obstructive Pulmonary Disease Patients With Respiratory Failure
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
June 21, 2021 (Actual)
Study Completion Date
July 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Guangzhou Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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.The diaphragm electromyogram (EMGdi) represents the neural drive to the diaphragm.A multi-pair esophageal electrode catheter was used to record the EMGdi.The PEEPi was assessed by the by the balloon-catheter in the multi-pair esophageal electrode catheter. In present study the PEEPi of COPD patients was increased by increasing the resistance of the respiratory system, the change of the neural drive( EMGdi) was obtained from the a multi-pair esophageal electrode catheter All the signal recorded in the computer. The relation the nreural drive assessed by EMGdi and intrinsic positive end-expiratory pressure(PEEPi) would be analysed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
neural respiratory drive, Intrinsic Positive End-expiratory Pressure, Chronic Obstructive Pulmonary Disease Patients
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
the chronic obstructive pulmonary disease patients with respiratory failure
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
neural respiratory drive
Arm Type
Experimental
Arm Description
neural respiratory drive assessed by EMGdi recorded from a multipair esophageal electrode
Intervention Type
Other
Intervention Name(s)
Resistance of the respiratory system
Intervention Description
increase the resistance of the respiratory system of the chronic obstructive pulmonary disease patients
Primary Outcome Measure Information:
Title
neural respiratory drive assessed by the root mean square of diaphragm electromyogram (EMGdi) of the chronic obstructive pulmonary disease patients with respiratory failure
Description
neural respiratory drive assessed by the root mean square of diaphragm electromyogram (EMGdi) obtained from the a multi-pair esophageal electrode catheter
Time Frame
1 hour
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
chronic obstructive pulmonary disease patients with respiratory failure
Exclusion Criteria:
Heart failure
cardiac dysrhythmia
Loss of consciousness
Facility Information:
Facility Name
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
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
520120
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
we will share our data by publishing the paper
Learn more about this trial
The Relationship Between the Neural Drive and Intrinsic Positive End-expiratory Pressure
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