ED Decision Making Among Hypotensive Patients

• Conditions: Hypotension
• Interventions: Device: Mespere Venus 1000 CVP System

• Registration Number: NCT02221908
• Lead Sponsor: Mespere Lifesciences Inc.

Brief Summary

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

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 Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-18
• Study First Submitted QC: 2014-08-20
• Study First Posted: 2014-08-21
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-25
• Last Update Posted: 2015-09-28
• Primary Completion: 2016-03
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients brought to Hahnemann Hospital ED	Mespere Venus 1000 CVP System	-

Primary Outcome Measures

Name	Time	Method
The correspondence of resuscitation decision and CVP value	At patient admission to ED	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.

Trial Locations

Locations (1)

Hahnemann Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States