Assessment of Neural Inspiratory Time Through sEMG and EMGdi

Copd Clinical Trial

Official title:

Assessment of Neural Inspiratory Time Through Transesophageal and Surface Electromyography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04211038
• Other study ID #: GIRH-201278
• Status: Recruiting
• Phase: N/A
• Start date: December 27, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: February 2021
• Source: Guangzhou Medical University
• Contact: Zhenfeng He
• Phone: +8613678935748
• Email: zfhe_2019[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Copd
• Rehabilitation
• Respiratory Aspiration
• Ventilation

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangzhou Medical University.	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Zhenfeng He	Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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