Transcutaneous Electrical Diaphragmatic Stimulation in PMV Patients

Mechanical Ventilation Clinical Trial

Official title:

Effects of Transcutaneous Electrical Diaphragmatic Stimulation on Respiratory Function in Patients With Prolonged Mechanical Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04281810
• Other study ID #: 201700096A3D001
• Status: Completed
• Phase: N/A
• Start date: April 20, 2017
• Est. completion date: July 25, 2019

Study information

• Verified date: February 2020
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Muscle atrophy and diaphragm dysfunction are common with prolonged mechanical ventilation (PMV). Electrical stimulation has been shown to be beneficial in severe chronic heart failure and chronic obstructive pulmonary disease. However, its effect on PMV is unclear. This study examined the effects of transcutaneous electrical diaphragmatic stimulation (TEDS) on respiratory muscle strength and weaning outcomes in patients with PMV.

Description:

Patients on ventilation for ≥21 days were randomly assigned to TEDS and control groups. The TEDS group received muscle electrical stimulation for 30 min/session/day throughout the intervention. Weaning parameters (tidal volume, respiratory rate, and rapid shallow breathing index) and respiratory muscle strength (Pimax, Pemax) were assessed. The hospitalization outcome, including weaning rate and length of stay, was followed up until discharge.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: July 25, 2019
• Est. primary completion date: September 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Age = 20 years;

• MV for > 6 h/day for > 21 days;

• Medical stability (PaO2 = 60 mmHg at 40% FiO2, absence of signs and symptoms of infection, and hemodynamic stability).

Exclusion Criteria:

• Acute lung or systemic infection, hemodynamic instability, patients with pacemakers, abdominal distention, and pregnancy.

Related Conditions & MeSH terms

• Mechanical Ventilation

Intervention

Device:
• transcutaneous electric diaphragm stimulation
The electrodes were placed on the parasternal region beside the xiphoid process; and the sixth and seventh intercostal spaces in line with the mid-axillary line. TEDS was set as biphasic waves, frequency of 30 Hz, pulse width of 400 µs, and rise time of 0.7s.

Locations

Country	Name	City	State
Taiwan	Chang Gung University	TaoYuan City	Tao-Yuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tidal volume	The tidal volume was measured by a spirometer	1st day of intervention
Primary	tidal volume	The tidal volume was measured by a spirometer	through study completion,an average of 4 weeks
Primary	rapid shallow breathing index	respiratory rate/tidal volume	1st day of intervention
Primary	rapid shallow breathing index	respiratory rate/tidal volume	through study completion,an average of 4 weeks
Primary	respiratory muscle strength (maximal inspiratory pressure)	pressure gauge	the 1st day of intervention
Primary	respiratory muscle strength (maximal expiratory pressure)	pressure gauge	the 1st day of intervention
Primary	respiratory muscle strength (maximal inspiratory pressure)	pressure gauge	through study completion,an average of 4 weeks
Primary	respiratory muscle strength (maximal expiratory pressure)	pressure gauge	through study completion,an average of 4 weeks
Secondary	weaning rate	ventilator weaning results (weaning successful/failure)	through study completion,an average of 7 weeks
Secondary	length of stay in respiratory care center	the total days of stay in respiratory care center	through study completion,an average of 7 weeks