Back to resultsMeasuring Hand Edema in Burn Patients
Primary Purpose
Edema
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
figure-of-eight hand measurements
water volumetry hand measurements
Sponsored by
About this trial
This is an interventional diagnostic trial for Edema focused on measuring Hand Edema, Figure of eight method, Measuring edema in burn patients
Eligibility 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
Sites / Locations
- U.S. Army Institute of Surgical Research
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00137228
First Posted
August 25, 2005
Last Updated
December 24, 2007
Sponsor
United States Army Institute of Surgical Research
1. Study Identification
Unique Protocol Identification Number
NCT00137228
Brief Title
Measuring Hand Edema in Burn Patients
Official Title
The Reliability and Concurrent Validity of the Figure-of-Eight Method of Measuring Hand Edema in Patients With Burn Injuries
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
United States Army Institute of Surgical Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edema
Keywords
Hand Edema, Figure of eight method, Measuring edema in burn patients
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
figure-of-eight hand measurements
Intervention Type
Procedure
Intervention Name(s)
water volumetry hand measurements
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Dewey, PT, CHT, OCS
Organizational Affiliation
US Army Institute of Surgical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
U.S. Army Institute of Surgical Research
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15233395
Citation
Leard JS, Breglio L, Fraga L, Ellrod N, Nadler L, Yasso M, Fay E, Ryan K, Pellecchia GL. Reliability and concurrent validity of the figure-of-eight method of measuring hand size in patients with hand pathology. J Orthop Sports Phys Ther. 2004 Jun;34(6):335-40. doi: 10.2519/jospt.2004.34.6.335.
Results Reference
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Measuring Hand Edema in Burn Patients
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