Bedside Evaluation of Edema

NCT03296085 | Terminated

• 1 other identifier: 2017-0434
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Edema

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Exam for quantity of edema PROCEDURE

There is no intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients with edema

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (1)

Geisinger Holy Spirit

Camp Hill, Pennsylvania, 17011, United States

Location

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard Schreiber, MD

  Geisinger Holy Spirit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Medical Informatics Officer

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: September 28, 2017
• Study Start: November 30, 2017
• Primary Completion: December 12, 2022
• Study Completion: December 30, 2022
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)