Transcutaneous Electrical Diaphragmatic Stimulation in PMV Patients

NCT04281810 | Completed

• 1 other identifier: 201700096A3D001
• 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; respiratory muscle

Outcome Measures

Primary Outcomes (8)

• tidal volume

  The tidal volume was measured by a spirometer

  1st day of intervention

• tidal volume

  The tidal volume was measured by a spirometer

  through study completion,an average of 4 weeks

• rapid shallow breathing index

  respiratory rate/tidal volume

  1st day of intervention

• rapid shallow breathing index

  respiratory rate/tidal volume

  through study completion,an average of 4 weeks

• respiratory muscle strength (maximal inspiratory pressure)

  pressure gauge

  the 1st day of intervention

• respiratory muscle strength (maximal expiratory pressure)

  pressure gauge

  the 1st day of intervention

• respiratory muscle strength (maximal inspiratory pressure)

  pressure gauge

  through study completion,an average of 4 weeks

• respiratory muscle strength (maximal expiratory pressure)

  pressure gauge

  through study completion,an average of 4 weeks

Secondary Outcomes (2)

• weaning rate

  through study completion,an average of 7 weeks

• length of stay in respiratory care center

  through study completion,an average of 7 weeks

Study Arms (2)

TEDS

EXPERIMENTAL

Subjects received transcutaneous electrical diaphragm stimulation (TEDS) for 30min/ day till the end of the weaning trial

Device: transcutaneous electric diaphragm stimulation

Control

NO INTERVENTION

Subjects received similar medical treatment except for the TEDS program.

Interventions

transcutaneous electric diaphragm stimulation DEVICE

The electrodes were placed on the parasternal region beside the xiphoid process; and the sixth and seventh intercostal spaces in line with the mid-axillary line. TEDS was set as biphasic waves, frequency of 30 Hz, pulse width of 400 μs, and rise time of 0.7s.

TEDS

Eligibility Criteria

• Age: 20 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 (PaO2 ≥ 60 mmHg at 40% FiO2, absence of signs and symptoms of infection, and hemodynamic stability).

You may not qualify if:

• Acute lung or systemic infection, hemodynamic instability, patients with pacemakers, abdominal distention, and pregnancy.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung University

Taoyuan, Tao-Yuan, 333, Taiwan

Location

Study Officials

• Yi-Fei Hsin

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Yen-Huey Chen

  Chang Gung University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects were not informed of the results of allocation
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 24, 2020
• Study Start: April 20, 2017
• Primary Completion: September 29, 2018
• Study Completion: July 25, 2019
• Last Updated: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)