Ultrasound Evaluation of Abdominal Muscle Thickness During Mechanical Ventilation

NCT04939298 | Completed

• 2 other identifiers: 2020/012020-A03186-33
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Weakness of respiratory muscles is frequent after several days of mechanical ventilation. Thereby an acquired diaphragm weakness has been demonstrated, linked to an atrophy which may be identified by a decrease of muscle thickness in echography. This study aims to evaluate with ultrasound the variation of thickness of abdominal muscles after 7 days of mechanical ventilation.

Conditions

Ventilation Therapy; Complications

Keywords

abdominal muscles; ultrasound

Outcome Measures

Primary Outcomes (1)

• Thickness of the abdominal muscles (mm)

  It is the sum of the thickness of rectus abdominal muscle + external oblique + internal oblique + transverse muscles.

  Day 7

Secondary Outcomes (16)

• Thickness of the rectus abdominal muscles (mm)

  Day 7

• Thickness of the external oblique abdominal muscles (mm)

  Day 7

• Thickness of the internal oblique abdominal muscles (mm)

  Day 7

• Thickness of the transverse abdominal muscles (mm)

  Day 7

• Diaphragmatic thickness (mm)

  Day 7

Study Arms (1)

Patients under mechanical ventilation

EXPERIMENTAL

Ultrasound evaluation of the variation of thickness of abdominal muscles after 7 days of mechanical ventilation

Device: Ultrasound

Interventions

Ultrasound DEVICE

Ultrasound evaluation of the variation of thickness of abdominal muscles after 7 days of mechanical ventilation.

Patients under mechanical ventilation

Eligibility Criteria

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

You may qualify if:

• Patient affiliated or entitled to a social security plan
• Expected duration of mechanical ventilation \> 7 days
• Trusted person/relative who has signed a consent to participate in the study

You may not qualify if:

• Patient with a pre-existing neuromuscular pathology
• No access to ultrasound Windows (dressing, drainages...)
• Patient transferred from another intensive care unit
• Patient Under guardianship or curators

Sponsors & Collaborators

• Centre Hospitalier de Roanne: lead
• Centre Hospitalier Universitaire de Saint Etienne: collaborator

Study Sites (1)

Centre Hospitalier de Roanne

Roanne, 42328, France

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Pascal Beuret, MD

  HOPITAL DE ROANNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 25, 2021
• Study Start: July 15, 2021
• Primary Completion: November 16, 2023
• Study Completion: November 16, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)