- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05396066
Respiratory and Quadriceps Muscle Fatigability After an ICU Acquired Weakness
July 10, 2024 updated by: Groupe Hospitalier du Havre
Comparison Between Respiratory and Quadriceps Muscle Fatigability During a Maximal Loading for ICU Weakness Patients
Muscle dysfunction can be lead to poor outcomes moreover ICU muscle weakness recovery are not correctly described.
The investigators aimed to assess the ability for quadriceps or respiratory muscles to repeat an effort at a maximal loading.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Groupe Hospitalier Du Havre
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Montivilliers, Groupe Hospitalier Du Havre, France, 76290
- Groupe Hospitalier Du Havre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients weaned from mechanical ventilation and developping ICU muscle weakness diagnosed by a maximal inspiratory pressure and a MRC score
Description
Inclusion Criteria:
- Mechanically ventilated at least at 24 Hours
- Maximal inspiratory pressure < 30 centimeter of water
- MRC score < 48/60
Exclusion Criteria:
- Age < 18 years
- Patients with neurological pathology or pre existing neuromuscular dysfunction
- Patient unable to walk 50 meters before ICU admission
- Patient with a thoracic or abdominal surgery
- Inability to carry out maximal voluntary contraction
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Respiratory muscle strength
Time Frame: One day
|
Respiratory muscle strength will be assessed by Maximal Inspiratory pressure in centimeter of water.
The measure will carry out by an electronical manometer
|
One day
|
|
Change in quadriceps muscle strength
Time Frame: One day
|
Quadriceps muscle strength will be assessed by Maximal Voluntary contraction of the quadriceps in Newton.
The measure will carry out by an electronical dynamometer
|
One day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2022
Primary Completion (Actual)
December 31, 2023
Study Completion (Actual)
February 1, 2024
Study Registration Dates
First Submitted
March 10, 2022
First Submitted That Met QC Criteria
May 24, 2022
First Posted (Actual)
May 31, 2022
Study Record Updates
Last Update Posted (Actual)
July 11, 2024
Last Update Submitted That Met QC Criteria
July 10, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-A02816-35
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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