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Completed

NCT Number: NCT04939298

Ultrasound Evaluation of Abdominal Muscle Thickness During Mechanical Ventilation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de Roanne

Roanne, 42328, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound

Device

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

Primary outcomes

  1. Thickness of the abdominal muscles (mm)

    Time frame: Day 7

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

Secondary outcomes

  1. Thickness of the rectus abdominal muscles (mm)

    Time frame: Day 7

    Thickness of the rectus abdominal muscles (mm) by ultrasound measurement.

  2. Thickness of the external oblique abdominal muscles (mm)

    Time frame: Day 7

    Thickness of the external oblique abdominal muscles (mm) by ultrasound measurement

  3. Thickness of the internal oblique abdominal muscles (mm)

    Time frame: Day 7

    Thickness of the internal oblique abdominal muscles (mm) by ultrasound measurement

  4. Thickness of the transverse abdominal muscles (mm)

    Time frame: Day 7

    Thickness of the transverse abdominal muscles (mm) by ultrasound measurement

  5. Diaphragmatic thickness (mm)

    Time frame: Day 7

    Diaphragmatic thickness (mm) measured by ultrasound

  6. Diaphragmatic thickness (mm)

    Time frame: Immediately after the successful extubation of the patient

    Diaphragmatic thickness (mm) measured by ultrasound

  7. Number of day with a contraction of the transverse abdominal muscle

    Time frame: 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

  8. Caught peak expiratory flow (CPEF) (cmH2O)

    Time frame: 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

  9. Maximum expiratory pressure (l/min)

    Time frame: Day 7

    Only for conscious patients, responding to the simple command and tolerating minimal respiratory support maximum expiratory pressure (PE max) measurement

  10. Thickness of the external oblique abdominal muscle (mm)

    Time frame: Immediately after the successful extubation of the patient

    External oblique abdominal muscle by ultrasound measurement

  11. Thickness of the internal oblique abdominal muscle (mm)

    Time frame: Immediately after the successful extubation of the patient

    Internal oblique abdominal muscle by ultrasound measurement

  12. Thickness of the transverse abdominal muscle (mm)

    Time frame: Immediately after the successful extubation of the patient

    Transverse abdominal muscle by ultrasound measurement

  13. Thickness of the rectus abdominal muscle (mm)

    Time frame: Immediately after the successful extubation of the patient

    Rectus abdominal muscle by ultrasound measurement

  14. Number of day between day 7 and successful extubation day (days)

    Time frame: From Day 7 to the day when the patient will be extubated successfully

  15. Duration of sedation (Day)

    Time frame: At intensive care unit discharge

  16. Duration of curarization (Day)

    Time frame: At intensive care unit discharge

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Roanne

Other

Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne

Registry information

Acronym: ABDO-VM

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 25, 2021
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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