Transcutaneous Diaphragm Electrical Stimulation in Critically Ill Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-10

Study Completion Date

2022-08-03

Brief Summary

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This study evaluates the effect of a transcutaneous electrical stimulation in critically ill patients compared to a sham electrical stimulation to decrease the incidence of diaphragm dysfunction before mechanical ventilation weaning.

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Detailed Description

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Conditions

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Critical Illness Mechanical Ventilation Intensive Care Unit

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sham Group

Two channels with two electrodes each were placed above and below the right and left sides of the xiphoid process within the seventh and eighth anterior intercostal space. In addition, two channels with two electrodes each were placed on the right and left midaxillary line of the seventh and eighth anterior intercostal space.

Transcutaneous electrical stimulation settings: Frequency (2 hertz); wave length (300 µs);

Group Type SHAM_COMPARATOR

Sham electrical stimulation

Intervention Type DEVICE

A non invasive sham diaphragm electrical stimulation using transcutaneous thoracic probes

Transcutaneous diaphragm electrical stimulation group

Two channels with two electrodes each were placed above and below the right and left sides of the xiphoid process within the seventh and eighth anterior intercostal space. In addition, two channels with two electrodes each were placed on the right and left midaxillary line of the seventh and eighth anterior intercostal space.

Transcutaneous electrical stimulation settings: Frequency (35 hertz); wave length (300 µs); Intensity to achieve a visual contraction

Group Type EXPERIMENTAL

Transcutaneous diaphragm electrical stimulation

Intervention Type DEVICE

A non invasive diaphragm electrical stimulation using transcutaneous thoracic probes

Interventions

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Sham electrical stimulation

A non invasive sham diaphragm electrical stimulation using transcutaneous thoracic probes

Intervention Type DEVICE

Transcutaneous diaphragm electrical stimulation

A non invasive diaphragm electrical stimulation using transcutaneous thoracic probes

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients intubated and ventilated for at least 24 h
* Patients who were expected to have at least 48h after inclusion

Exclusion Criteria

* Patient with pacemaker
* Patient under neuro muscular blocker
* Patient post thoracic or abdominal surgery
* Patient with BMI more than 35 kg/m²
* Patient with degenerative neurological pathology
* Patient with cutaneous lesion may be interfered with probes
* Patient with chronic loss of autonomy
* Patient hospitalized more than 72 hours before ICU admission
* Patient with severe chronic obstructive pulmonary disease (FEV1 \< 30%)
* Patient with decision to withhold life-sustaining treatment

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No