ED Decision Making Among Hypotensive Patients

The goal of this study is to assess decision making skills of emergency physicians when dealing with hypotensive patients. The hypothesis is that decisions made based on physical exam and vital signs regarding fluid resuscitation by emergency physicians are not statistically equivalent to those that would be made based on the use of a non-invasive CVP measurement

Study Overview

• Status: Unknown
• Conditions: Hypotension
• Intervention / Treatment: Device: Mespere Venus 1000 CVP System

Detailed Description

If physicians can make appropriate decisions about the need for fluid resuscitation without CVP measurement, then this skill is worth being passed to physicians in training. Previously it was not possible gather enough information about the response of patients' because of the risk of using indwelling CVP sensors. But now because there is a low risk tool (Venus 1000 System), this study is now practical and safe.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
      • Hahnemann Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients brough to Hahnemann Hospital ED

Description

Inclusion Criteria:

• All patients >=18 years of age who enter the Emergency Department at Hahnemann Hospital with Systolic Blood pressure < 100 mm Hg

Exclusion Criteria:

• Those patients who are suffering from traumatic injury requiring Level I or Level II trauma evaluations. Example conditions include penetrating injuries to head, torso and proximal extremities.
• Additional exclusion criteria include the presence of an internal jugular or a subclavian central venous line or both external jugular veins being cannulated (attempted or successful) with peripheral IVs.
• Pregnant females will be excluded.
• Subjects under the age of 18 years will be excluded

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients brought to Hahnemann Hospital ED	Device: Mespere Venus 1000 CVP System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The correspondence of resuscitation decision and CVP value	The non-invasive CVP will be measured at the time of initial ordering decision by the ED physician. Afterwards, its relationship to the decision about whether to start intravenous fluid resuscitation will be analyzed.	At patient admission to ED

Collaborators and Investigators

• Sponsor: Mespere Lifesciences Inc.
• Investigators: Principal Investigator: Neal Handly, MD, Drexel University

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): March 1, 2016
• Study Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: August 18, 2014
• First Submitted That Met QC Criteria: August 20, 2014
• First Posted (Estimate): August 21, 2014

Study Record Updates

• Last Update Posted (Estimate): September 28, 2015
• Last Update Submitted That Met QC Criteria: September 25, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Systolic Blood pressure < 100 mm Hg
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: IRB1401002513