ICU Acquired WeaknessDETECTNCT04722445
Ultrasound Measurement of Quadriceps Shortening During Neuromuscular Electrical Stimulation in Critically Ill Patients
An observational study of ICU Acquired Weakness and Quadriceps Muscle Atrophy, run by Groupe Hospitalier du Havre at 1 site in France.
Trial summary
ICU-Aw is highly prevalent (50%) among critically ill patients. Its diagnosis is usually delayed as it requires patients' awakening and collaboration to provide accurate measurement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Acquired Weakness, Quadriceps Muscle Atrophy
- What is being tested?
- Early ultrasound measurement of quadriceps shortening during neuromuscular electrical stimulation (NMES)
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 16 Aug 2021to 30 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients admitted in ICU departement and mechanically ventilated for at least 24 hours without counterindications to provide NMES.
Who may be able to join
- Mechanical ventilation for at least 24 hours
Who cannot join
- Decision to withhold life-sustaining treatment
- Pregnancy
- Degenerative neurological pathology with disabling muscle weakness
- Pace Maker
- Inability to communicate
- Chronic loss of autonomy described by the patient's family
- Guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Accuracy of Early ulTrasound Measurement of Quadriceps Thickness During Neuromuscular EleCTrical Stimulation for the Diagnosis of ICU-acquired Weakness : an Observational Study (DETECT)
ICU-Aw is highly prevalent (50%) among critically ill patients. Its diagnosis is usually delayed as it requires patients' awakening and collaboration to provide accurate measurement.
This study aims to investigate the accuracy of an early ultrasound measurement of quadriceps shortening during neuromuscular electrical stimulation to diagnose future ICU-Aw in critically ill patients.
- Conditions
- ICU Acquired Weakness, Quadriceps Muscle Atrophy
- Being tested
- Early ultrasound measurement of quadriceps shortening during neuromuscular electrical stimulation (NMES)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early ultrasound measurement of quadriceps shortening during neuromuscular electrical stimulation (NMES)Diagnostic test
NMES will be applied to the quadriceps muscle to generate muscle contraction. Ultrasound measurement of the quadriceps thickness will be provided during contraction and rest, and the shortening of the quadriceps muscle will be measured. A second measurement using Shear-wave elastography measurement will also be undertaken. The measures will be undertaken at day 1 of neuromuscular blockers liberation (if any) as well as at day 3 and day 7 for the patients that will still be received mechanical ventilation at that time.
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU-Aw diagnosis
Measured with the Medical Research Council score (scored 0 (minimum) to 60 (maximum); with a score < 48 meaning ICU-acquired weakness)
Measured: In the 24 hours following extubation
Secondary outcomes (3)
Respiratory muscles strength
Maximal Inspiratory Pressure and Maximal Expiratory Pressure
Measured: In the 30 minutes before extubation (during spontaneous breathing trial)
Cough capacity
Peak Cough Flow
Measured: In the 30 minutes before extubation (during spontaneous breathing trial)
Extubation failure/success
Reintubation or death
Measured: Within 48 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start16 Aug 2021
- Primary completion16 Oct 2023
- Study completion30 Dec 2023
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier du Havre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yann Combret, PhD, PT, Principal investigator, Groupe Hospitalier du Havre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722445
- Sponsor's protocol ID
- 2020-A01690-39
- Acronym
- DETECT
- Status last verified
- Jul 2024
- First submitted
- 22 Oct 2020
- Last updated
- 11 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
Medrinal C, Combret Y, Hilfiker R, Prieur G, Aroichane N, Gravier FE, Bonnevie T, Contal O, Lamia B. ICU outcomes can be predicted by noninvasive muscle evaluation: a meta-analysis. Eur Respir J. 2020 Oct 1;56(4):1902482. doi: 10.1183/13993003.02482-2019. Print 2020 Oct.
PubMed 32366493
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
- Diagnostic Accuracy of Early ulTrasound Measurement of Quadriceps Thickness During Neuromuscular EleCTrical Stimulation for the Diagnosis of ICU-acquired Weakness : an Observational Study (DETECT)
- ClinicalTrials.gov ID
- NCT04722445
- Acronym / sponsor ID
- DETECT / 2020-A01690-39
- Conditions
- ICU Acquired Weakness, Quadriceps Muscle Atrophy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Groupe Hospitalier du HavreUniversity, hospital or other
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 25 Jan 2021 (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.
ICU-Aw is highly prevalent (50%) among critically ill patients. Its diagnosis is usually delayed as it requires patients' awakening and collaboration to provide accurate measurement.
This study aims to investigate the accuracy of an early ultrasound measurement of quadriceps shortening during neuromuscular electrical stimulation to diagnose future ICU-Aw in critically ill patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients admitted in ICU departement and mechanically ventilated for at least 24 hours without counterindications to provide NMES.
Key inclusion criteria (1 listed)
- Mechanical ventilation for at least 24 hours
Key exclusion criteria (7 listed)
- Decision to withhold life-sustaining treatment
- Pregnancy
- Degenerative neurological pathology with disabling muscle weakness
- Pace Maker
- Inability to communicate
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 |
|---|---|---|
| Early ultrasound measurement of quadriceps shortening during neuromuscular electrical stimulation (NMES)NMES will be applied to the quadriceps muscle to generate muscle contraction. Ultrasound measurement of the quadriceps thickness will be provided during contraction and rest, and the shortening of the quadriceps muscle will be measured. A second measurement using Shear-wave elastography measurement will also be undertaken. The measures will be undertaken at day 1 of neuromuscular blockers liberation (if any) as well as at day 3 and day 7 for the patients that will still be received mechanical ventilation at that time. | Diagnostic test | – |
Primary outcome
ICU-Aw diagnosis
Time frame: In the 24 hours following extubation
Measured with the Medical Research Council score (scored 0 (minimum) to 60 (maximum); with a score < 48 meaning ICU-acquired weakness)
3 secondary outcomes
Respiratory muscles strength
Time frame: In the 30 minutes before extubation (during spontaneous breathing trial)
Cough capacity
Time frame: In the 30 minutes before extubation (during spontaneous breathing trial)
Extubation failure/success
Time frame: Within 48 hours after extubation
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.
- Background: PubMed 32366493Medrinal C, Combret Y, Hilfiker R, Prieur G, Aroichane N, Gravier FE, Bonnevie T, Contal O, Lamia B. ICU outcomes can be predicted by noninvasive muscle evaluation: a meta-analysis. Eur Respir J. 2020 Oct 1;56(4):1902482. doi: 10.1183/13993003.02482-2019. Print 2020 Oct.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Yann Combret, PhD, PT principal investigator
Groupe Hospitalier du Havre
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 and Quadriceps Muscle Atrophy, 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 1 inclusion and 7 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?
ICU-Aw diagnosis (time frame: In the 24 hours following extubation). 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 NCT04722445, 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.