ED Decision Making Among Hypotensive Patients

NCT ID: NCT02221908

Last Updated: 2015-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-04-30

Brief Summary

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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

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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.

Conditions

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Hypotension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients brought to Hahnemann Hospital ED

Mespere Venus 1000 CVP System

Intervention Type DEVICE

Interventions

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Mespere Venus 1000 CVP System

Intervention Type DEVICE

Eligibility Criteria

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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.
* Pregnant females will be excluded.
* Subjects under the age of 18 years will be excluded
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mespere Lifesciences Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neal Handly, MD

Role: PRINCIPAL_INVESTIGATOR

Drexel University

Locations

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Hahnemann Hospital

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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IRB1401002513

Identifier Type: -

Identifier Source: org_study_id

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