Transcutaneous Electrical Diaphragmatic Stimulation in PMV Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation
• Intervention / Treatment: Device: transcutaneous electric diaphragm stimulation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tao-Yuan
    • TaoYuan City, Tao-Yuan, Taiwan, 333
      • Chang Gung University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TEDS; Subjects received transcutaneous electrical diaphragm stimulation (TEDS) for 30min/ day till the end of the weaning trial	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.
No Intervention: Control; Subjects received similar medical treatment except for the TEDS program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tidal volume	The tidal volume was measured by a spirometer	1st day of intervention
tidal volume	The tidal volume was measured by a spirometer	through study completion,an average of 4 weeks
rapid shallow breathing index	respiratory rate/tidal volume	1st day of intervention
rapid shallow breathing index	respiratory rate/tidal volume	through study completion,an average of 4 weeks
respiratory muscle strength (maximal inspiratory pressure)	pressure gauge	the 1st day of intervention
respiratory muscle strength (maximal expiratory pressure)	pressure gauge	the 1st day of intervention
respiratory muscle strength (maximal inspiratory pressure)	pressure gauge	through study completion,an average of 4 weeks
respiratory muscle strength (maximal expiratory pressure)	pressure gauge	through study completion,an average of 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weaning rate	ventilator weaning results (weaning successful/failure)	through study completion,an average of 7 weeks
length of stay in respiratory care center	the total days of stay in respiratory care center	through study completion,an average of 7 weeks

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Yi-Fei Hsin, Chang Gung Memorial Hospital; Study Director: Yen-Huey Chen, Chang Gung University

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2017
• Primary Completion (Actual): September 29, 2018
• Study Completion (Actual): July 25, 2019

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: February 21, 2020
• First Posted (Actual): February 24, 2020

Study Record Updates

• Last Update Posted (Actual): February 24, 2020
• Last Update Submitted That Met QC Criteria: February 21, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: electrical stimulation; weaning; respiratory muscle; diaphragmatic
• Other Study ID Numbers: 201700096A3D001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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