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Completed

NCT Number: NCT04741724

TEDS in Prolonged Mechanical Ventilation

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–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept of Respiratory therapy, Chang Gung University

Taoyuan, 333, Taiwan

About this study

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.

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

Exclusion criteria

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

Treatment and study plan

TEDS

Device

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

Other names: transcutaneous electrical diaphragmatic stimulation

Primary outcomes

  1. breathing frequency

    Time frame: through study completion, an average of 2 weeks

    The pulmonary function as assessed by the measurement of respiratory rate

  2. Pimax

    Time frame: through study completion, an average of 2 weeks

    The pulmonary function as assessed by the measurement of max inspiratory pressure

  3. Vt

    Time frame: through study completion, an average of 2 weeks

    The pulmonary function as assessed by the measurement of tidal volume

Secondary outcomes

  1. RCC days

    Time frame: through study completion, an average of 6 weeks

    The total days that participants stay in the respiratory care center

  2. weaning rate

    Time frame: through study completion, an average of 6 weeks

    the status of ventilator use

Sponsors and collaborators

Lead sponsor

Chang Gung University

Other

Registry information

Official study title

Effect of Transcutaneous Electrical Diaphragmatic Stimulation in Prolonged Mechanical Ventilation

Acronym: TEDS

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Feb 5, 2021
Registry last updated
Aug 30, 2023

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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