Ultrasound Evaluation of Abdominal Muscle Thickness During Mechanical Ventilation

Ventilation Therapy; Complications Clinical Trial

— ABDO-VM  

Official title:

Ultrasound Evaluation of Abdominal Muscle Thickness During Mechanical Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04939298
• Other study ID #: 2020/01
• Secondary ID: 2020-A03186-33
• Status: Completed
• Phase: N/A
• Start date: July 15, 2021
• Est. completion date: November 16, 2023

Study information

• Verified date: February 2024
• Source: Centre Hospitalier de Roanne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 16, 2023
• Est. primary completion date: November 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ventilation Therapy; Complications

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier de Roanne	Roanne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier de Roanne	Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

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