Study of Intensive Care Unit (ICU)-Acquired Weakness (Handgrip Strength Study)

Clinical Determinants of Handgrip Strength in Critically Ill Adults: Pilot Study

To better understand ICU-acquired weakness in patients requiring mechanical ventilation in the Intensive Care Unit.

Study Overview

• Status: Completed
• Conditions: Peripheral Muscle Strength

Detailed Description

We have generated the hypothesis that handgrip strength can be used to develop our understanding of the effects of critical illness on peripheral muscle strength.

To begin to develop this hypothesis, a better understanding of the determinants of handgrip strength needs to be developed. As a result we propose to perform a prospective observational study examining the clinical factors that are associated with handgrip strength. Several clinical factors are known to be associated with increased risk of developing ICUAP while hospitalized: multiple organ failure, severe sepsis, female gender and treatments like steroids. As many of these risk factors are not modifiable, the opportunity to intervene is unclear. However, by attempting to better describe the spectrum of strength deficits experienced by critically ill patients we may better be able to dissect and prevent ICUAP.

• Study Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

subjects requiring prolonged mechanical ventilation in the ICU

Description

Inclusion Criteria:

• • Adult patients admitted to the Medical ICU

  • Age ≥ 18 years of age at ICU admit.
  • Requiring mechanical ventilation for at least 24 hours

Exclusion Criteria:

• • Moribund or in the process of withdrawal of life support

  • Patient, family or physicians not in favor of continued support until awakening.
  • Profound neurologic injury associated with little or no chance of awakening.
  • Active consideration of a diagnosis of brain death by treating physicians.
  • Known history of chronic neurological disease resulting in muscle weakness in more than two limbs.
  • Inability to perform handgrip dynamometry prior to acute illness.
  • Subject is a Non-english speaker
  • Subject or surrogate unable to provide informed consent.
  • ICU stay of greater than 24 hours within the last thirty days or at any point during the current hospitalization
  • Greater than seven days of hospital care prior to hospital admission.
  • Greater than five days since inclusion criteria met.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1.; Those with ICU-acquired weakness

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the feasibility of performing serial assessments of strength (handgrip and limb muscle strength) in a broad population of critically ill patients.	duration of ICU stay-up to 10 days

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine the acute medical illnesses associated with weakness	duration of ICU stay-up to 10 days
To determine the modifiable risk factors associated with weakness	duration of ICU stay-up to 10 days
To determine if there is an association between handgrip strength and ICUAP risk	duration of ICU stay-up to 10 days
To generate a set of normative data for handgrip strength in critically ill patients adjusting for important non-modifiable risk factors	duration of ICU stay-up to 10 days

Collaborators and Investigators

• Sponsor: Naeem Ali, MD
• Investigators: Principal Investigator: Naeem A. Ali, M.D., Ohio State University

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: June 17, 2008
• First Submitted That Met QC Criteria: June 18, 2008
• First Posted (Estimate): June 19, 2008

Study Record Updates

• Last Update Posted (Estimate): January 18, 2016
• Last Update Submitted That Met QC Criteria: January 15, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: ICU acquired paresis
• Other Study ID Numbers: 2008H0081