Bedside Evaluation of Edema

Edema Clinical Trial

— EDEMA  

Official title:

A Simple Technique for Quantitative Evaluation of an Important Clinical Sign

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03296085
• Other study ID #: 2017-0434
• Status: Terminated
• Start date: November 30, 2017
• Est. completion date: December 30, 2022

Study information

• Verified date: June 2023
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 30, 2022
• Est. primary completion date: December 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Currently admitted patients

• Patient who can understand the purpose of the study and sign a consent form

• Patient has a measurable amount of edema

• Patient will likely be available during the time the clinicians can examine the patient

Exclusion Criteria:

• Unable or unwilling to sign the consent form

• No measurable edema

• Currently in isolation for infection control purposes

• Patients in the Behavioral Health section of the hospital

• Maternity patients (due to availability of infant rooming-in)

• Prisoners

• Age below 18 years

• Patients with bilateral lower extremity amputation

Related Conditions & MeSH terms

• Edema

Intervention

Procedure:
• Exam for quantity of edema
There is no intervention

Locations

Country	Name	City	State
United States	Geisinger Holy Spirit	Camp Hill	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Geisinger Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inter-observer correlation of edema measurement before instruction in novel technique	Observe the variation in edema documentation based on standard examination technique	one day
Primary	Inter-observer correlation of edema measurement after instruction in novel technique	Observe the variation in edema documentation based on the novel examination technique	one day

External Links

•   Preprint of intraobserver reliability data at doi:10.21203/rs.3.rs-2362872/v1