TEDS in Prolonged Mechanical Ventilation

NCT ID: NCT04741724

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2019-03-01

Brief 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.

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.

Conditions

Mechanical Ventilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

TEDS

Intervention Type: DEVICE

An non-invasive intervention. During the intervention, the electrode was placed on the skin stimulated muscle.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

TEDS

An non-invasive intervention. During the intervention, the electrode was placed on the skin stimulated muscle.

Intervention Type: DEVICE

Other Intervention Names

transcutaneous electrical diaphragmatic stimulation

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung University

OTHER

Sponsor Role: lead

Responsible Party

Chen Yen-Huey

Associate lecture

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yen-Huey Chen, PhD

Role: STUDY_DIRECTOR

Chang Gung University

Locations

Dept of Respiratory therapy, Chang Gung University

Taoyuan District, , Taiwan

Countries

Taiwan

Other Identifiers

201700096A3

Identifier Type: -

Identifier Source: org_study_id