ICU Acquired WeaknessNCT05396066
Respiratory and Quadriceps Muscle Fatigability After an ICU Acquired Weakness
An observational study of ICU Acquired Weakness, run by Groupe Hospitalier du Havre at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ICU Acquired Weakness
- What is being tested?
- Muscle evaluation
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2022to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients weaned from mechanical ventilation and developping ICU muscle weakness diagnosed by a maximal inspiratory pressure and a MRC score
Who may be able to join
- Mechanically ventilated at least at 24 Hours
- Maximal inspiratory pressure < 30 centimeter of water
- MRC score < 48/60
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier du Havre
Montivilliers, Groupe Hospitalier Du Havre, 76290
About this study
Official title: 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.
- Conditions
- ICU Acquired Weakness
- Being tested
- Muscle evaluation
- Keywords
- ICU acquired weakness, Muscle strength, fatigability, respiratory muscle, Quadriceps muscle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle evaluationDiagnostic test
Repeated maximal voluntary contraction
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Respiratory muscle strength
Respiratory muscle strength will be assessed by Maximal Inspiratory pressure in centimeter of water. The measure will carry out by an electronical manometer
Measured: One day
Change in quadriceps muscle strength
Quadriceps muscle strength will be assessed by Maximal Voluntary contraction of the quadriceps in Newton. The measure will carry out by an electronical dynamometer
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start15 Jun 2022
- Primary completion31 Dec 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ICU Acquired WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier du Havre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396066
- Sponsor's protocol ID
- 2021-A02816-35
- Status last verified
- Jul 2024
- First submitted
- 10 Mar 2022
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Machefert M, Prieur G, Aubry S, Combret Y, Medrinal C. Respiratory and limb muscles' ability to repeatedly generate maximal isometric strength in patients with intensive care unit-acquired weakness: an observational study. BMC Anesthesiol. 2025 Mar 20;25(1):134. doi: 10.1186/s12871-025-03008-y.
PubMed 40114068
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Respiratory and Quadriceps Muscle Fatigability During a Maximal Loading for ICU Weakness Patients
- ClinicalTrials.gov ID
- NCT05396066
- Acronym / sponsor ID
- 2021-A02816-35
- Conditions
- ICU Acquired Weakness
- Keywords
- ICU acquired weakness, Muscle strength, fatigability, respiratory muscle, Quadriceps muscle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Groupe Hospitalier du HavreUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients weaned from mechanical ventilation and developping ICU muscle weakness diagnosed by a maximal inspiratory pressure and a MRC score
Key inclusion criteria (3 listed)
- Mechanically ventilated at least at 24 Hours
- Maximal inspiratory pressure < 30 centimeter of water
- MRC score < 48/60
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle evaluationRepeated maximal voluntary contraction | Diagnostic test | – |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Derived from this study: PubMed 40114068Machefert M, Prieur G, Aubry S, Combret Y, Medrinal C. Respiratory and limb muscles' ability to repeatedly generate maximal isometric strength in patients with intensive care unit-acquired weakness: an observational study. BMC Anesthesiol. 2025 Mar 20;25(1):134. doi: 10.1186/s12871-025-03008-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ICU Acquired Weakness, run by Groupe Hospitalier du Havre at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Respiratory muscle strength (time frame: One day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05396066, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.