Handgrip Strength Value in Predicting Mechanical Ventilation Weaning

NCT ID: NCT02946502

Last Updated: 2020-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 261 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-17
• Study Completion Date: 2020-07-31

Brief Summary

The purpose of this study is to test the association between ICU acquired weakness as evaluated by dominant handheld dynamometry (handgrip) and the mechanical ventilation weaning outcome

Detailed Description

Previous studies have evidenced that Intensive Care Unit acquired peripheral muscle weakness may lead to delayed mechanical ventilation weaning (i.e difficult or prolonged weaning according to guidelines). Nevertheless, no study has ever tested the association between handgrip strength and extubation outcome. The investigators have generated the hypothesis that ICU acquired weakness, as tested by handgrip strength might be associated with extubation outcome. The investigators have planned to include 240 patients. Handgrip strength will be monitored, along with a full muscular assessment through Medical Research Council score by the attending physiotherapist. Physicians in charge of the patients will be blinded to these values and the weaning protocol will continue according to guidelines.

Conditions

Ventilator Weaning; Hand Strength; Respiration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Handheld dynamometry (handgrip strength)

All included patients will have a blinded evaluation of handgrip strength before weaning process.

Group Type: EXPERIMENTAL

Handheld dynamometry (handgrip strength)

Intervention Type: PROCEDURE

Patients will perform handgrip strength dynamometry through holding the device in their dominant hand with the maximum strength, with standardized arm and body positions, as well as incentives

Interventions

Handheld dynamometry (handgrip strength)

Patients will perform handgrip strength dynamometry through holding the device in their dominant hand with the maximum strength, with standardized arm and body positions, as well as incentives

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• adult patients
• under mechanical ventilation for at least 48 hours
• meeting readiness to wean criteria according to international guidelines
• with social security
• informed consent given by the patient or a proxy

Exclusion Criteria

• baseline pre existing rheumatologic or neurologic condition preventing the patient to use the tested device
• confusion (as assessed by Confusion Assessment Method for the Intensive Care Unit )
• Patients whose extubation is a terminal extubation, or with prior decision not to resort a reintubation in case of post-extubation respiratory distress.
• known pregnancy
• Inability to deliver clear patient information (language barrier without an interpreter, for example)
• Participation in another intervention research

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Benjamin Sztrymf

Clamart, , France

Countries

France

References

Cottereau G, Messika J, Megarbane B, Guerin L, da Silva D, Bornstain C, Santos M, Ricard JD, Sztrymf B. Handgrip strength to predict extubation outcome: a prospective multicenter trial. Ann Intensive Care. 2021 Oct 2;11(1):144. doi: 10.1186/s13613-021-00932-3.

Reference Type: DERIVED

PMID: 34601639 (View on PubMed)

Other Identifiers

P150948

Identifier Type: -

Identifier Source: org_study_id