Clinical Trials Directory

Trials / Terminated

TerminatedNCT03296085

Bedside Evaluation of Edema

A Simple Technique for Quantitative Evaluation of an Important Clinical Sign

Status
Terminated
Phase
Study type
Observational
Enrollment
1 (actual)
Sponsor
Geisinger Clinic · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Edema, commonly called swelling, is a common medical condition, with many causes. Clinicians generally find edema by pressing against a patient's skin, usually on the feet or shins, and observing how much dimpling there is in the skin. Most clinicians estimate the amount on a scale of mild to severe, or perhaps state the amount as 1 to 4. There is little agreement between observers, and it is hard to judge different clinicians' use of these scales. The first part of this experiment will demonstrate this inconsistency. After clinicians are shown a new technique for measuring edema, the second part of the study will show more accurate and consistent measurements. This will help clinicians to measure edema better, and to communicate their findings to other clinicians more effectively.

Detailed description

The research team will recruit as many clinicians who are conveniently available for the study. Clinicians will include attending physicians from any specialty, residents, medical students, physician assistants, physician assistant students, nurses, certified nurse practitioners, and certified nurse practitioner students. Once patients and clinicians have been recruited, the research team will maintain a list of the patients and a grid of which clinicians are to examine which patients. Each clinician will be given a data collection sheet, listing the patients' room numbers, and a grid for recording results for each of the patient's affected limb(s). The first data collection sheet (before instruction on the quantitative method) will just show a blank free text field so that clinicians can record their results as they normally do. After instruction in the novel quantitative technique, the clinicians will receive another data collection sheet now indicating the intent to have the clinicians record their findings in millimeters. The expectation is that a minimum of 6 examiners will determine the extent of edema on at least 38 limbs. If possible, the research will continue until approximately 100 limbs have been examined by a total of at least 10 to 20 clinicians.

Conditions

Interventions

TypeNameDescription
PROCEDUREExam for quantity of edemaThere is no intervention

Timeline

Start date
2017-11-30
Primary completion
2022-12-12
Completion
2022-12-30
First posted
2017-09-28
Last updated
2023-06-28

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03296085. Inclusion in this directory is not an endorsement.