TEDS in Prolonged Mechanical Ventilation (TEDS)

Effect of Transcutaneous Electrical Diaphragmatic Stimulation in 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: TEDS

Detailed Description

Subjects on ventilation for ≥21 days were randomly assigned to TEDS or control groups. The TEDS group received muscle electrical stimulation for 30 min/session/day throughout the intervention. Weaning parameters 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
  • Taoyuan, Taiwan, 333
    • Dept of Respiratory therapy, Chang Gung University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. age ≥ 20 years;
2. MV for > 6 h/day for > 21 days;
3. medical stability

Exclusion Criteria:

1. acute lung or systemic infection,
2. hemodynamic instability,
3. abdominal distention,
4. pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: transcutaneous electrical diaphragmatic stimulation (TEDS); Subjects received daily TEDS (30min/day, 5days/week ) until the end of the weaning trial. During TEDS, rectangular electrodes were placed on the parasternal region beside the xiphoid process; the sixth and seventh intercostal spaces in line with the mid-axillary line. TEDS was performed by applying biphasic waves at a stimulation frequency of 30 Hz, pulse width of 400 μs. TEDS intensity was gradually increased until visible muscle contraction was observed. Each session lasts for 30 min day.	Device: TEDS; An non-invasive intervention. During the intervention, the electrode was placed on the skin stimulated muscle.; Other Names: transcutaneous electrical diaphragmatic stimulation
No Intervention: Control group; Subjects in the control group did not received TEDS program. Subjects in the control group received the same pre- and post-measurement as those in TEDS group. The control group received medical treatment as those in TEDS group. The pulmonary function was measured at the beginning and end of the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
breathing frequency	The pulmonary function as assessed by the measurement of respiratory rate	through study completion, an average of 2 weeks
Pimax	The pulmonary function as assessed by the measurement of max inspiratory pressure	through study completion, an average of 2 weeks
Vt	The pulmonary function as assessed by the measurement of tidal volume	through study completion, an average of 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RCC days	The total days that participants stay in the respiratory care center	through study completion, an average of 6 weeks
weaning rate	the status of ventilator use	through study completion, an average of 6 weeks

Collaborators and Investigators

• Sponsor: Chang Gung University
• Investigators: Study Director: Yen-Huey Chen, PhD, Chang Gung University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: electrical stimulation; weaning; diaphragmatic
• Other Study ID Numbers: 201700096A3

Drug and device information, study documents

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