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

July 10, 2024 updated by: Groupe Hospitalier du Havre

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

80

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

  • France
      • Montivilliers, 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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Critically ill patients admitted in ICU departement and mechanically ventilated for at least 24 hours without counterindications to provide NMES.

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
In the 24 hours following extubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory muscles strength
Time Frame: In the 30 minutes before extubation (during spontaneous breathing trial)
Maximal Inspiratory Pressure and Maximal Expiratory Pressure
In the 30 minutes before extubation (during spontaneous breathing trial)
Cough capacity
Time Frame: In the 30 minutes before extubation (during spontaneous breathing trial)
Peak Cough Flow
In the 30 minutes before extubation (during spontaneous breathing trial)
Extubation failure/success
Time Frame: Within 48 hours after extubation
Reintubation or death
Within 48 hours after extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier du Havre

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 16, 2021

Primary Completion (Actual)

October 16, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

October 22, 2020

First Submitted That Met QC Criteria

January 22, 2021

First Posted (Actual)

January 25, 2021

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

  • 2020-A01690-39

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

IPD Sharing Time Frame

Beginning after publication and ending 60 months following article publication.

IPD Sharing Access Criteria

For individual participant data meta-analysis. Proposals should be directed to yann.combret@gmail.com. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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