NCT03991702

Brief Summary

The handgrip strength (HGS) will be measured with a digital dynamometer. Three measurements will be taken, whose average of the three measurements will be collected. Muscle weakness will be diagnosed based on previously published ICU acquired weakness (ICU-AW) scores (for males \<11 kg and females \<7 kg). The overall motor function of the patient will be assessed using the Medical Research Council (MRC) scale. The maximum score of the scale is 60 points, adding the degree of muscle strength of all muscle groups tested. If the patient is unable to have one of the limbs tested, it is assumed that the limb would have the same force as the contralateral limb. A score of 48 points or less is indicative of muscle weakness. Individuals who scored between 48 and 37 points on the MRC scale are considered to have significant weaknesses; those with 36 points or less are classified as severely weak. The HGS and the MRC scale will be compared as predictors of weaning duration of mechanical ventilation

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 19, 2019

Completed
Last Updated

June 19, 2019

Status Verified

June 1, 2019

Enrollment Period

1.1 years

First QC Date

May 29, 2019

Last Update Submit

June 18, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • mechanical ventilation weaning time

    to evaluate the hand grip strength as a predictor of spontaneous breathing test failure and the duration of mechanical ventilation weaning.

    30 days

  • Duration of mechanical ventilation

    to evaluate the Medical Research Council scale as a predictor of spontaneous breathing test failure and the duration of mechanical ventilation. The MRC score is obtained by evaluating 12 muscle groups in the upper extremities (wrist extensors, elbow flexors and abductors of the shoulder) and lower extremities (dorsal ankle flexors, knee extensors, and hip flexors). For each muscle group will be assigned a score between 0 (complete paralysis) and 5 (normal force), and the total score can vary between 0 up to 60 points.

    30 days

Secondary Outcomes (1)

  • HGS cut-off points indicative of ICU acquired Weakness

    30 days

Interventions

diagnostic testDIAGNOSTIC_TEST

The overall motor function of the patient will be assessed using the Medical Research Council (MRC) scale and Palmar dynamometer strength

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients on invasive mechanical ventilation for more than 48 hours and ready to perform the spontaneous breathing test.

You may qualify if:

  • age over 18 years
  • being on invasive mechanical ventilation for more than 48 hours
  • fulfill the pre-defined criteria for performing the spontaneous breathing test

You may not qualify if:

  • \- patients unable to perform the hand grip strength test and the MRC scale (any rheumatologic conditions, neuromuscular, amputation, cachexia, neuropsychiatric symptoms: such as confusion and delirium)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035007, Brazil

Location

MeSH Terms

Interventions

Diagnostic Tests, Routine

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Gilberto Friedman, Prof

    Hospital de Clinicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2019

First Posted

June 19, 2019

Study Start

March 1, 2016

Primary Completion

March 30, 2017

Study Completion

April 30, 2017

Last Updated

June 19, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations