Measuring Hand Edema in Burn Patients

This study has been completed.
Sponsor:
Information provided by:
United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:
NCT00137228
First received: August 25, 2005
Last updated: December 24, 2007
Last verified: December 2007
  Purpose

The purpose of this study is to determine the reliability and concurrent validity of the figure-of-eight method of measuring hand edema in the burn patient population. Establishing the reliability and validity would enable a more time efficient assessment than the currently accepted methods.


Condition Intervention
Edema
Procedure: figure-of-eight hand measurements
Procedure: water volumetry hand measurements

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Reliability and Concurrent Validity of the Figure-of-Eight Method of Measuring Hand Edema in Patients With Burn Injuries

Resource links provided by NLM:


Further study details as provided by United States Army Institute of Surgical Research:

Primary Outcome Measures:
  • The figure-of-eight method for measuring hand edema in burn patients is just as reliable and valid as water volumetry measurement. [ Time Frame: 24 hours ]

Enrollment: 20
Study Start Date: January 2005
Study Completion Date: November 2006
Detailed Description:

A prospective study involving 33 burn patients admitted to the US Army Burn Center. Two raters will perform three separate blinded measurements for hand edema using the figure-of-eight measurement technique. A third rater will then perform two blinded measurements using water volumetry. All measurements will be read and recorded by an independent recorder. The three measurements of rater 1 and 2 will be analyzed to determine intratester reliability. The average of the three figure-of-eight measurements will be compared to measure intertester reliability. The two volumetry measurements will be compared to determine intratester reliability. The average of the 2 volumetry measurements and the average fo the three figure-of-eight measurements will be used to determine concurrent validity.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female 18-89 years old
  • Admitted to the United States (U.S.) Army Burn Intensive Care Unit (ICU) or ward with burn injury and the presence of bilateral or unilateral hand edema

Exclusion Criteria:

  • Subject unable to be placed in test position for volumetry testing or the presence of a medical condition, as defined by a physician, that precludes the safe use of volumetry.
  • Subject is unable to tolerate his/her hand(s) being immersed in room temperature water for volumetry testing.
  • Subject does not have any of the bony landmarks (due to amputation, previous surgery) required to perform the figure-of-eight measurement
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00137228

Locations
United States, Texas
U.S. Army Institute of Surgical Research
Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
United States Army Institute of Surgical Research
Investigators
Principal Investigator: Scott Dewey, PT, CHT, OCS US Army Institute of Surgical Research
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00137228     History of Changes
Other Study ID Numbers: H-04-030
Study First Received: August 25, 2005
Last Updated: December 24, 2007
Health Authority: United States: Federal Government

Keywords provided by United States Army Institute of Surgical Research:
Hand Edema
Figure of eight method
Measuring edema in burn patients

Additional relevant MeSH terms:
Edema
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014