TEDS in Prolonged Mechanical Ventilation

Not Applicable

Completed

• Conditions: Mechanical Ventilation
• Interventions: Device: TEDS

• Registration Number: NCT04741724
• Lead Sponsor: Chang Gung University

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.

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2018-12-31
• Study Completion: 2019-03-01
• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-03
• Study First Posted: 2021-02-05
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transcutaneous electrical diaphragmatic stimulation (TEDS)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dept of Respiratory therapy, Chang Gung University; 🇨🇳 Taoyuan, Taiwan