TEDS in Prolonged Mechanical Ventilation

NCT04741724 | Completed

• 1 other identifier: 201700096A3
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation

Keywords

electrical stimulation; diaphragmatic; weaning

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• RCC days

  through study completion, an average of 6 weeks

• weaning rate

  through study completion, an average of 6 weeks

Study Arms (2)

transcutaneous electrical diaphragmatic stimulation (TEDS)

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

TEDS DEVICE

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

Also known as: transcutaneous electrical diaphragmatic stimulation

transcutaneous electrical diaphragmatic stimulation (TEDS)

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 20 years;
• MV for \> 6 h/day for \> 21 days;
• medical stability

You may not qualify if:

• acute lung or systemic infection,
• hemodynamic instability,
• abdominal distention,
• pregnancy.

Sponsors & Collaborators

• Chang Gung University: lead

Study Sites (1)

Dept of Respiratory therapy, Chang Gung University

Taoyuan District, 333, Taiwan

Location

Study Officials

• Yen-Huey Chen, PhD

  Chang Gung University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate lecture

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 5, 2021
• Study Start: July 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: March 1, 2019
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

TW (1)