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
About this trial
This is an interventional other trial for Copd
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
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
NCT ID
NCT04211038
First Posted
December 22, 2019
Last Updated
February 20, 2021
Sponsor
Zhenfeng He
Collaborators
Guangzhou Medical University
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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