Handgrip Strength Value in Predicting Mechanical Ventilation Weaning

Ventilator Weaning Clinical Trial

— GRIPWEAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02946502
• Other study ID #: P150948
• Status: Completed
• Phase: N/A
• Start date: January 17, 2017
• Est. completion date: July 2020

Study information

• Verified date: July 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: July 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hand Strength
• Respiration
• Ventilator Weaning

Intervention

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

Locations

Country	Name	City	State
France	Benjamin Sztrymf	Clamart

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	extubation outcome according to handgrip strength value	Each mechanical ventilation weaning trial	7 days
Secondary	Association between handgrip strength and difficulty of weaning according to guidelines	Each mechanical ventilation weaning trial	7 days
Secondary	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
Secondary	Association between handgrip strength and maximal inspiratory strength during a brief inspiratory valve occlusion on the ventilator	Each mechanical ventilation weaning trial	7 days
Secondary	Association between handgrip strength and peripheral muscular strength evaluated by the Medical Research Council score	Each mechanical ventilation weaning trial	7 days
Secondary	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
Secondary	Association between handgrip strength defined Intensive Care Unit acquired weakness and Intensive Care Unit and hospital length of stay		18 months
Secondary	Association between handgrip strength defined Intensive Care Unit acquired weakness and Intensive Care Unit and hospital survival		18 months