Assessment of Neural Inspiratory Time Through sEMG and EMGdi

Assessment of Neural Inspiratory Time Through Transesophageal and Surface Electromyography

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.

Study Overview

• Status: Unknown
• Conditions: Ventilation; Rehabilitation; Copd
• Intervention / Treatment: Device: inspiratory threshold load device

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital of Guangzhou Medical University.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the onset and duration of neural inspiratory time	Correlation between onsets and duration of measured from espphageal pressure, transdiaphragmatie pressure and EMG.	through study completion, an average of 5 hours

Collaborators and Investigators

• Sponsor: Zhenfeng He
• Collaborators: Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 27, 2019
• Primary Completion (ANTICIPATED): December 30, 2021
• Study Completion (ANTICIPATED): December 30, 2021

Study Registration Dates

• First Submitted: December 22, 2019
• First Submitted That Met QC Criteria: December 22, 2019
• First Posted (ACTUAL): December 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 20, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: GIRH-201278

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No