NCT05396066

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

June 15, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

July 11, 2024

Status Verified

July 1, 2024

Enrollment Period

1.5 years

First QC Date

March 10, 2022

Last Update Submit

July 10, 2024

Conditions

ICU Acquired Weakness

Keywords

ICU acquired weaknessMuscle strengthfatigabilityrespiratory muscleQuadriceps muscle

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    One day

Interventions

Muscle evaluationDIAGNOSTIC_TEST

Repeated maximal voluntary contraction

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients weaned from mechanical ventilation and developping ICU muscle weakness diagnosed by a maximal inspiratory pressure and a MRC score

You may qualify if:

  • Mechanically ventilated at least at 24 Hours
  • Maximal inspiratory pressure \< 30 centimeter of water
  • MRC score \< 48/60

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier du Havre

Montivilliers, Groupe Hospitalier Du Havre, 76290, France

Location

Related Publications (1)

  • 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.

    PMID: 40114068DERIVED

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2022

First Posted

May 31, 2022

Study Start

June 15, 2022

Primary Completion

December 31, 2023

Study Completion

February 1, 2024

Last Updated

July 11, 2024

Record last verified: 2024-07

Locations

FR(1)