Respiratory and Quadriceps Muscle Fatigability After an ICU Acquired Weakness

• Sponsor: Groupe Hospitalier du Havre (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05396066
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Anticipated Duration (Months): 6.6
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ICU Acquired Weakness	Diagnostic Test: Muscle evaluation

Study Design

• Study Type: Observational
• Anticipated Enrollment: 20 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Comparison Between Respiratory and Quadriceps Muscle Fatigability During a Maximal Loading for ICU Weakness Patients
• Actual Study Start Date: Jun 15, 2022
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Jan 1, 2023

Outcome Measures

Primary Outcome Measures

1. Change in Respiratory muscle strength [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

2. Change in quadriceps muscle strength [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Mechanically ventilated at least at 24 Hours

• Maximal inspiratory pressure < 30 centimeter of water

• MRC score < 48/60

Exclusion Criteria:

• 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

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Groupe Hospitalier du Havre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Groupe Hospitalier du Havre
• ClinicalTrials.gov Identifier: NCT05396066
• Other Study ID Numbers: 2021-A02816-35
• First Posted: May 31, 2022
• Last Update Posted: Aug 8, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Groupe Hospitalier du Havre: ICU acquired weakness; Muscle strength; fatigability; respiratory muscle; Quadriceps muscle
• Additional relevant MeSH terms: Asthenia

Study Results

No Results Posted as of Aug 8, 2022