Assessment of Neural Inspiratory Time Through sEMG and EMGdi

NCT04211038 | Unknown

• 1 other identifier: GIRH-201278
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Copd; Ventilation; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

healthy subjects

EXPERIMENTAL

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

COPD subjects

EXPERIMENTAL

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

Interventions

inspiratory threshold load device 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.

Also known as: cycle ergometer

COPD subjects; healthy subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• systemic application of corticosteroids nearly 4 weeks

Sponsors & Collaborators

• Zhenfeng He: lead
• Guangzhou Medical University: collaborator

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University.

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Central Study Contacts

Zhenfeng He

CONTACT

+8613678935748; zfhe_2019@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: December 22, 2019
• First Posted: December 26, 2019
• Study Start: December 27, 2019
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: February 23, 2021

Record last verified: 2021-02

Locations

CN (1)