Bedside Evaluation of Edema (EDEMA)

A Simple Technique for Quantitative Evaluation of an Important Clinical Sign

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.

Study Overview

• Status: Terminated
• Conditions: Edema
• Intervention / Treatment: Procedure: Exam for quantity of edema

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.

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • Geisinger Holy Spirit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients with edema

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter-observer correlation of edema measurement before instruction in novel technique	Observe the variation in edema documentation based on standard examination technique	one day
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

Collaborators and Investigators

• Sponsor: Geisinger Clinic
• Investigators: Principal Investigator: Richard Schreiber, MD, Geisinger Holy Spirit

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2017
• Primary Completion (Actual): December 12, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: September 25, 2017
• First Submitted That Met QC Criteria: September 25, 2017
• First Posted (Actual): September 28, 2017

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Edema
• Other Study ID Numbers: 2017-0434

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No