Ultrasound Evaluation of Abdominal Muscle Thickness During Mechanical Ventilation

Not Applicable

Completed

• Conditions: Ventilation Therapy; Complications
• Interventions: Device: Ultrasound

• Registration Number: NCT04939298
• Lead Sponsor: Centre Hospitalier de Roanne

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.

Detailed Description

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. Weakness of expiratory muscles is also frequent after 7 days of mechanical ventilation, however his cause is not clear: is it present at admission notably in elderly patients, or acquired on mechanical ventilation ? Ultrasound allows to measure the thickness of abdominal muscles which correlates with their strength. This study aims to evaluate with ultrasound the variation of thickness of abdominal muscles after 7 days of mechanical ventilation.

Study Timeline

• Study First Submitted: 2021-06-11
• Study First Submitted QC: 2021-06-17
• Study First Posted: 2021-06-25
• Study Start: 2021-07-15
• Primary Completion: 2023-11-16
• Study Completion: 2023-11-16
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients under mechanical ventilation	Ultrasound	Ultrasound evaluation of the variation of thickness of abdominal muscles after 7 days of mechanical ventilation

Primary Outcome Measures

Name	Time	Method
Thickness of the abdominal muscles (mm)	Day 7	It is the sum of the thickness of rectus abdominal muscle + external oblique + internal oblique + transverse muscles.

Secondary Outcome Measures

Name	Time	Method
Duration of curarization (Day)	At intensive care unit discharge
Thickness of the rectus abdominal muscle (mm)	Immediately after the successful extubation of the patient	Rectus abdominal muscle by ultrasound measurement
Thickness of the rectus abdominal muscles (mm)	Day 7	Thickness of the rectus abdominal muscles (mm) by ultrasound measurement.
Diaphragmatic thickness (mm)	Immediately after the successful extubation of the patient	Diaphragmatic thickness (mm) measured by ultrasound
Thickness of the transverse abdominal muscle (mm)	Immediately after the successful extubation of the patient	Transverse abdominal muscle by ultrasound measurement
Thickness of the external oblique abdominal muscles (mm)	Day 7	Thickness of the external oblique abdominal muscles (mm) by ultrasound measurement
Number of day with a contraction of the transverse abdominal muscle	From day 1 to day 7	Ultrasound search for a contraction of the transverse abdominal muscle during the morning clinical examination each day from D1 to D7
Thickness of the external oblique abdominal muscle (mm)	Immediately after the successful extubation of the patient	External oblique abdominal muscle by ultrasound measurement
Thickness of the internal oblique abdominal muscle (mm)	Immediately after the successful extubation of the patient	Internal oblique abdominal muscle by ultrasound measurement
Number of day between day 7 and successful extubation day (days)	From Day 7 to the day when the patient will be extubated successfully
Thickness of the transverse abdominal muscles (mm)	Day 7	Thickness of the transverse abdominal muscles (mm) by ultrasound measurement
Maximum expiratory pressure (l/min)	Day 7	Only for conscious patients, responding to the simple command and tolerating minimal respiratory support maximum expiratory pressure (PE max) measurement
Thickness of the internal oblique abdominal muscles (mm)	Day 7	Thickness of the internal oblique abdominal muscles (mm) by ultrasound measurement
Caught peak expiratory flow (CPEF) (cmH2O)	Day 7	Only for conscious patients, responding to the simple command and tolerating minimal respiratory support (inspiratory support 7 cmH20, Pep 0 cmH20) caught peak expiratory flow (CPEF) measurement
Duration of sedation (Day)	At intensive care unit discharge

Trial Locations

Locations (1)

Centre Hospitalier de Roanne; 🇫🇷 Roanne, France