Handgrip Strength Value in Predicting Mechanical Ventilation Weaning

Not Applicable

Completed

• Conditions: Ventilator Weaning; Respiration; Hand Strength
• Interventions: Procedure: Handheld dynamometry (handgrip strength)

• Registration Number: NCT02946502
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2016-10-18
• Study First Submitted QC: 2016-10-25
• Study First Posted: 2016-10-27
• Study Start: 2017-01-17
• Primary Completion: 2019-11
• Status Verified: 2020-07
• Study Completion: 2020-07
• Last Update Submitted: 2020-07-01
• Last Update Posted: 2020-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 261

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Handheld dynamometry (handgrip strength)	Handheld dynamometry (handgrip strength)	All included patients will have a blinded evaluation of handgrip strength before weaning process.

Primary Outcome Measures

Name	Time	Method
extubation outcome according to handgrip strength value	7 days	Each mechanical ventilation weaning trial

Secondary Outcome Measures

Name	Time	Method
Association between handgrip strength and cough strength as assessed through peak expiratory flow evaluated with a portable spirometer	7 days	Each mechanical ventilation weaning trial
Association between handgrip strength and maximal inspiratory strength during a brief inspiratory valve occlusion on the ventilator	7 days	Each mechanical ventilation weaning trial
Association between handgrip strength defined Intensive Care Unit acquired weakness and Intensive Care Unit and hospital survival	18 months
Association between handgrip strength and difficulty of weaning according to guidelines	7 days	Each mechanical ventilation weaning trial
Association between handgrip strength and peripheral muscular strength evaluated by the Medical Research Council score	7 days	Each mechanical ventilation weaning trial
Association between handgrip strength and the peripheral muscular strength evaluated by the Medical Research Council score. (Global score and its components)	7 days	Each mechanical ventilation weaning trial
Association between handgrip strength defined Intensive Care Unit acquired weakness and Intensive Care Unit and hospital length of stay	18 months

Trial Locations

Locations (1)

Benjamin Sztrymf; 🇫🇷 Clamart, France