DETECT: Ultrasound Measurement of Quadriceps Shortening During Neuromuscular Electrical Stimulation in Critically Ill Patients

• Sponsor: Groupe Hospitalier du Havre (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04722445
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Anticipated Duration (Months): 13.5
• Patients Per Site Per Month: 5.9

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
ICU Acquired Weakness; Quadriceps Muscle Atrophy	Diagnostic Test: Early ultrasound measurement of quadriceps shortening during neuromuscular electrical stimulation (NMES)

Study Design

• Study Type: Observational
• Anticipated Enrollment: 80 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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)
• Actual Study Start Date: Aug 16, 2021
• Anticipated Primary Completion Date: Aug 16, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Outcome Measures

Primary Outcome Measures

1. ICU-Aw diagnosis [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)

Secondary Outcome Measures

1. Respiratory muscles strength [In the 30 minutes before extubation (during spontaneous breathing trial)]

   Maximal Inspiratory Pressure and Maximal Expiratory Pressure

2. Cough capacity [In the 30 minutes before extubation (during spontaneous breathing trial)]

   Peak Cough Flow

3. Extubation failure/success [Within 48 hours after extubation]

   Reintubation or death

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Mechanical ventilation for at least 24 hours

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Groupe Hospitalier du Havre	Montivilliers		France	76290

Sponsors and Collaborators

• Groupe Hospitalier du Havre

Investigators

• Principal Investigator: Yann Combret, PhD, PT, Groupe Hospitalier du Havre

Study Documents (Full-Text)

None provided.

More Information

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). pii: 1902482. doi: 10.1183/13993003.02482-2019. Print 2020 Oct.

• Responsible Party: Groupe Hospitalier du Havre
• ClinicalTrials.gov Identifier: NCT04722445
• Other Study ID Numbers: 2020-A01690-39
• First Posted: Jan 25, 2021
• Last Update Posted: Aug 25, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Muscular Atrophy; Asthenia

Study Results

No Results Posted as of Aug 25, 2021