Assessment of Neural Inspiratory Time Through sEMG and EMGdi

Sponsor
Zhenfeng He (Other)
Overall Status
Recruiting
CT.gov ID
NCT04211038
Collaborator
Guangzhou Medical University (Other)
30
1
2
24.1
1.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: inspiratory threshold load device
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Assessment of Neural Inspiratory Time Through Transesophageal and Surface Electromyography
Actual Study Start Date :
Dec 27, 2019
Anticipated Primary Completion Date :
Dec 30, 2021
Anticipated Study Completion Date :
Dec 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: healthy subjects

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.

Device: inspiratory threshold load device
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.
Other Names:
  • cycle ergometer
  • Experimental: COPD subjects

    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.

    Device: inspiratory threshold load device
    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.
    Other Names:
  • cycle ergometer
  • Outcome Measures

    Primary Outcome Measures

    1. the onset and duration of neural inspiratory time [through study completion, an average of 5 hours]

      Correlation between onsets and duration of measured from espphageal pressure, transdiaphragmatie pressure and EMG.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affiliated Hospital of Guangzhou Medical University. Guangzhou Guangdong China

    Sponsors and Collaborators

    • Zhenfeng He
    • Guangzhou Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhenfeng He, principal investigator, Guangzhou Medical University
    ClinicalTrials.gov Identifier:
    NCT04211038
    Other Study ID Numbers:
    • GIRH-201278
    First Posted:
    Dec 26, 2019
    Last Update Posted:
    Feb 23, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 23, 2021