Clinical trial NCT02946502: Handgrip Strength Value in Predicting Mechanical Ventilation Weaning
Official title: Prognostic Value of Dominant Hand Held Dynamometry in Mechanical Ventilation Weaning: a Prospective, Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator Weaning
Hand Strength
Respiration
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-10-27
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: extubation outcome according to handgrip strength value
timeFrame: 7 days
Secondary outcomes:
measure: Association between handgrip strength and difficulty of weaning according to guidelines
timeFrame: 7 days
measure: Association between handgrip strength and cough strength as assessed through peak expiratory flow evaluated with a portable spirometer
timeFrame: 7 days
measure: Association between handgrip strength and maximal inspiratory strength during a brief inspiratory valve occlusion on the ventilator
timeFrame: 7 days
measure: Association between handgrip strength and peripheral muscular strength evaluated by the Medical Research Council score
timeFrame: 7 days
measure: Association between handgrip strength and the peripheral muscular strength evaluated by the Medical Research Council score. (Global score and its components)
timeFrame: 7 days
measure: Association between handgrip strength defined Intensive Care Unit acquired weakness and Intensive Care Unit and hospital length of stay
timeFrame: 18 months
measure: Association between handgrip strength defined Intensive Care Unit acquired weakness and Intensive Care Unit and hospital survival
timeFrame: 18 months
Other outcomes:
Locations:
city: Clamart
country: France
facility: Benjamin Sztrymf
Study officials:
References:
citation: 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.