Transcutaneous Diaphragm Electrical Stimulation in Critically Ill Patients

NCT04171024 | Completed Phase 4

• 1 other identifier: 2019-A00782-55
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Critical Illness; Mechanical Ventilation; Intensive Care Unit

Keywords

Diaphragm dysfunction; Transcutaneous Electrical Stimulation; Intensive care unit; Mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Diaphragm Thickening fraction

  Diaphragm ultrasound was conducted using a 4-12-MHz linear array transducer. Diaphragm thickness was measured at end-expiration (Tdi,ee) and end inspiration (Tdi,ei), and thickening fraction (TFdi) was calculated offline as (Tdi,ei-Tdi,ee)/Tdi,ee.

  Once, At the start of the spontaneous breathing trial

Secondary Outcomes (4)

• Diaphragm atrophy

  Once a day under mechanical ventilation, throughout the study

• Inspiratory strength

  Once, At the start of the spontaneous breathing trial

• Cough strength

  Once, At the start of the spontaneous breathing trial

• Proportion of patients successfully liberated from the ventilator

  After 3 days of spontaneous breathing

Study Arms (2)

Sham Group

SHAM COMPARATOR

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);

Device: Sham electrical stimulation

Transcutaneous diaphragm electrical stimulation group

EXPERIMENTAL

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

Device: Transcutaneous diaphragm electrical stimulation

Interventions

Sham electrical stimulation DEVICE

A non invasive sham diaphragm electrical stimulation using transcutaneous thoracic probes

Sham Group

Transcutaneous diaphragm electrical stimulation DEVICE

A non invasive diaphragm electrical stimulation using transcutaneous thoracic probes

Transcutaneous diaphragm electrical stimulation group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients intubated and ventilated for at least 24 h

You may not qualify if:

• 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

Sponsors & Collaborators

• Groupe Hospitalier du Havre: lead

Study Sites (1)

Medrinal

Le Havre, 76600, France

Location

Related Publications (1)

• Medrinal C, Machefert M, Lamia B, Bonnevie T, Gravier FE, Hilfiker R, Prieur G, Combret Y. Transcutaneous electrical diaphragmatic stimulation in mechanically ventilated patients: a randomised study. Crit Care. 2023 Aug 30;27(1):338. doi: 10.1186/s13054-023-04597-1.

  PMID: 37649092 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 20, 2019
• Study Start: December 10, 2019
• Primary Completion: August 2, 2022
• Study Completion: August 3, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-08

Locations

FR (1)