Transcutaneous Electrical Diaphragmatic Stimulation in PMV Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Mechanical Ventilation

Intervention / Treatment
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* Device: transcutaneous electric diaphragm stimulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TEDS<br>Subjects received transcutaneous electrical diaphragm stimulation (TEDS) for 30min/ day till the end of the weaning trial | Device: transcutaneous electric diaphragm stimulation<br>* 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.<br>|
| No Intervention: Control<br>Subjects received similar medical treatment except for the TEDS program. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weaning rate | ventilator weaning results (weaning successful/failure) | through study completion,an average of 7 weeks | 
| length of stay in respiratory care center | the total days of stay in respiratory care center | through study completion,an average of 7 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electrical stimulation, diaphragmatic, weaning, respiratory muscle