Measuring Hand Edema in Burn Patients

Study Overview
=================
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.

Official Title
-----------------
The Reliability and Concurrent Validity of the Figure-of-Eight Method of Measuring Hand Edema in Patients With Burn Injuries

Conditions
-----------------
Edema

Intervention / Treatment
-----------------
* Procedure: figure-of-eight hand measurements
* Procedure: water volumetry hand measurements


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: figure-of-eight hand measurements|nan|
|Procedure: water volumetry hand measurements|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The figure-of-eight method for measuring hand edema in burn patients is just as reliable and valid as water volumetry measurement. |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hand Edema, Figure of eight method, Measuring edema in burn patients