TEDS in Prolonged Mechanical Ventilation

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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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.

Official Title
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Effect of Transcutaneous Electrical Diaphragmatic Stimulation in Prolonged Mechanical Ventilation

Conditions
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Mechanical Ventilation

Intervention / Treatment
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* Device: TEDS


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 Exclusion Criteria: acute lung or systemic infection, hemodynamic instability, abdominal distention, pregnancy.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 100 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transcutaneous electrical diaphragmatic stimulation (TEDS)<br>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<br>* An non-invasive intervention. During the intervention, the electrode was placed on the skin stimulated muscle.<br>* Other names: transcutaneous electrical diaphragmatic stimulation;|
| No Intervention: Control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RCC days | The total days that participants stay in the respiratory care center | through study completion, an average of 6 weeks | 
| weaning rate | the status of ventilator use | through study completion, an average of 6 weeks | 

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