TEDS in Prolonged Mechanical Ventilation

Mechanical Ventilation Clinical Trial

— TEDS  

Official title:

Effect of Transcutaneous Electrical Diaphragmatic Stimulation in Prolonged Mechanical Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04741724
• Other study ID #: 201700096A3
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: August 2023
• Source: Chang Gung University
• 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: March 1, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mechanical Ventilation

Intervention

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

Locations

Country	Name	City	State
Taiwan	Dept of Respiratory therapy, Chang Gung University	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	breathing frequency	The pulmonary function as assessed by the measurement of respiratory rate	through study completion, an average of 2 weeks
Primary	Pimax	The pulmonary function as assessed by the measurement of max inspiratory pressure	through study completion, an average of 2 weeks
Primary	Vt	The pulmonary function as assessed by the measurement of tidal volume	through study completion, an average of 2 weeks
Secondary	RCC days	The total days that participants stay in the respiratory care center	through study completion, an average of 6 weeks
Secondary	weaning rate	the status of ventilator use	through study completion, an average of 6 weeks