Handgrip Strength Value in Predicting Mechanical Ventilation Weaning (GRIPWEAN)

Prognostic Value of Dominant Hand Held Dynamometry in Mechanical Ventilation Weaning: a Prospective, Multicenter Study

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

Study Overview

• Status: Completed
• Conditions: Respiration; Ventilator Weaning; Hand Strength
• Intervention / Treatment: Procedure: Handheld dynamometry (handgrip strength)

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 Type: Interventional
• Enrollment (Actual): 261
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clamart, France
    • Benjamin Sztrymf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Handheld dynamometry (handgrip strength); All included patients will have a blinded evaluation of handgrip strength before weaning process.	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
extubation outcome according to handgrip strength value	Each mechanical ventilation weaning trial	7 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 17, 2017
• Primary Completion (ACTUAL): November 1, 2019
• Study Completion (ACTUAL): July 1, 2020

Study Registration Dates

• First Submitted: October 18, 2016
• First Submitted That Met QC Criteria: October 25, 2016
• First Posted (ESTIMATE): October 27, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 2, 2020
• Last Update Submitted That Met QC Criteria: July 1, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: P150948

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO