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Completed

NCT Number: NCT04281810

Transcutaneous Electrical Diaphragmatic Stimulation in PMV Patients

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.

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Key information

Conditions

Mechanical Ventilation

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung University

Taoyuan City, Tao-Yuan, 333, Taiwan

About this study

Patients on ventilation for ≥21 days were randomly assigned to TEDS and control groups. The TEDS group received muscle electrical stimulation for 30 min/session/day throughout the intervention. Weaning parameters (tidal volume, respiratory rate, and rapid shallow breathing index) and respiratory muscle strength (Pimax, Pemax) were assessed. The hospitalization outcome, including weaning rate and length of stay, was followed up until discharge.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. tidal volume

    Time frame: 1st day of intervention

    The tidal volume was measured by a spirometer

  2. tidal volume

    Time frame: through study completion,an average of 4 weeks

    The tidal volume was measured by a spirometer

  3. rapid shallow breathing index

    Time frame: 1st day of intervention

    respiratory rate/tidal volume

  4. rapid shallow breathing index

    Time frame: through study completion,an average of 4 weeks

    respiratory rate/tidal volume

  5. respiratory muscle strength (maximal inspiratory pressure)

    Time frame: the 1st day of intervention

    pressure gauge

  6. respiratory muscle strength (maximal expiratory pressure)

    Time frame: the 1st day of intervention

    pressure gauge

  7. respiratory muscle strength (maximal inspiratory pressure)

    Time frame: through study completion,an average of 4 weeks

    pressure gauge

  8. respiratory muscle strength (maximal expiratory pressure)

    Time frame: through study completion,an average of 4 weeks

    pressure gauge

Secondary outcomes

  1. weaning rate

    Time frame: through study completion,an average of 7 weeks

    ventilator weaning results (weaning successful/failure)

  2. length of stay in respiratory care center

    Time frame: through study completion,an average of 7 weeks

    the total days of stay in respiratory care center

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Effects of Transcutaneous Electrical Diaphragmatic Stimulation on Respiratory Function in Patients With Prolonged Mechanical Ventilation

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Feb 24, 2020
Registry last updated
Feb 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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