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Assessment of Neural Inspiratory Time Through sEMG and EMGdi

Primary Purpose

Copd, Ventilation, Rehabilitation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
inspiratory threshold load device
Sponsored by
Zhenfeng He
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Copd

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • normal cardio-pulmonary function
  • without low inspiratory muscle strength
  • non-smoker
  • without history of the nervous system and respiratory system disease
  • sever to very severe stable stage

Exclusion Criteria:

  • systemic application of corticosteroids nearly 4 weeks

Sites / Locations

  • The First Affiliated Hospital of Guangzhou Medical University.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

healthy subjects

COPD subjects

Arm Description

Firstly, increase the inspiratory threshold load step by step(30%-80%MIP),in order to increase neural respiratory drive. Secondly, do incremental cycle ergometry test with the assisstance of NPPV.

Firstly, increase the inspiratory threshold load step by step(30%-80%MIP),in order to increase neural respiratory drive. Secondly, do incremental cycle ergometry test with the assisstance of NPPV.

Outcomes

Primary Outcome Measures

the onset and duration of neural inspiratory time
Correlation between onsets and duration of measured from espphageal pressure, transdiaphragmatie pressure and EMG.

Secondary Outcome Measures

Full Information

First Posted
December 22, 2019
Last Updated
February 20, 2021
Sponsor
Zhenfeng He
Collaborators
Guangzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04211038
Brief Title
Assessment of Neural Inspiratory Time Through sEMG and EMGdi
Official Title
Assessment of Neural Inspiratory Time Through Transesophageal and Surface Electromyography
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 27, 2019 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhenfeng He
Collaborators
Guangzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The onset and offset of the neural inspiratory time are fundamentally important measurements in studies of patientventilator interaction, where the level of assistance delivered by the ventilator is controlled by the patient's demand. The onset of neural inspiratory time can be determined in esophageal pressure, transdiaphragmatic pressure, and EMG signals. The investigator compare the onset measured by EMG, esophageal and transdiaphragmatic pressure, and consider that the correlation between them is well in different conditions.
Detailed Description
The onset and offset of the neural inspiratory time are fundamentally important measurements in studies of patien-tventilator interaction, where the level of assistance delivered by the ventilator is controlled by the patient's demand. Patient-ventilator asynchrony evaluated using the time lag between onset of the neural inspiratory time and the onset of a mechanical ventilation signal. The onset of neural inspiratory time can be determined in esophageal pressure, transdiaphragmatic pressure, and EMG signals. The investigator compare the onset measured by EMG, esophageal and transdiaphragmatic pressure, and consider that the correlation between them is well in three different conditions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Copd, Ventilation, Rehabilitation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
healthy subjects
Arm Type
Experimental
Arm Description
Firstly, increase the inspiratory threshold load step by step(30%-80%MIP),in order to increase neural respiratory drive. Secondly, do incremental cycle ergometry test with the assisstance of NPPV.
Arm Title
COPD subjects
Arm Type
Experimental
Arm Description
Firstly, increase the inspiratory threshold load step by step(30%-80%MIP),in order to increase neural respiratory drive. Secondly, do incremental cycle ergometry test with the assisstance of NPPV.
Intervention Type
Device
Intervention Name(s)
inspiratory threshold load device
Other Intervention Name(s)
cycle ergometer
Intervention Description
Before experiment ,every subject use a flanged mouthpiece attached to a manually operated occlusion valve in order to measure maximal inspiratory pressure (MIP)at functional residual capacity . And then, the healthy subjects will be increased the neural respiratory drive by increasing the pressure in a water-sealed inspiratory threshold loading device. At last, all subjects will do Incremental cycle ergometry test with the assisstance of NPPV.
Primary Outcome Measure Information:
Title
the onset and duration of neural inspiratory time
Description
Correlation between onsets and duration of measured from espphageal pressure, transdiaphragmatie pressure and EMG.
Time Frame
through study completion, an average of 5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: normal cardio-pulmonary function without low inspiratory muscle strength non-smoker without history of the nervous system and respiratory system disease sever to very severe stable stage Exclusion Criteria: systemic application of corticosteroids nearly 4 weeks
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenfeng He
Phone
+8613678935748
Email
zfhe_2019@163.com
Facility Information:
Facility Name
The First Affiliated Hospital of Guangzhou Medical University.
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenfeng He, MD
Phone
8602083062882
Email
zfHe_2019@163.com

12. IPD Sharing Statement

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Assessment of Neural Inspiratory Time Through sEMG and EMGdi

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