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Compass Device CVC Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03056859
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : March 25, 2020
Centurion Medical Products
Information provided by (Responsible Party):
Neal Gerstein, University of New Mexico

Brief Summary:
This is a single-arm observational trial of a device (Compass Vascular Access, Centurion Medical Products, Williamston MI). The device is a compact, sterile, single-use extravascular blood pressure transducer. This pressure measurement aids in confirmation of appropriate venous access. The investigators plan to enroll 40 consenting patients with BMI ≥35 who require central venous catheterization for clinical reasons independent of the existence of this study. The primary outcome is operator satisfaction.

Condition or disease Intervention/treatment
Blood Pressure Device: Extravascular blood pressure transducer

Detailed Description:
Forty (40) consenting patients meeting inclusion/exclusion criteria for this single-arm observational trial will be prepared as usual for central venous catheter (CVC) placement. The Compass pressure measurement device will be included in the CVC placement apparatus as per the manufacturer's directions. Data will be recorded on the placement procedure, operator satisfaction, routine patient demographics, and incidence of inadvertent arterial puncture.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Central Venous Catheterization in Obese Patients With Compass Device
Actual Study Start Date : February 17, 2017
Actual Primary Completion Date : February 10, 2020
Actual Study Completion Date : February 10, 2020

Group/Cohort Intervention/treatment
Enrolled Patients
Procedure: Central venous catheter placement with extravascular blood pressure transducer
Device: Extravascular blood pressure transducer
Listed device is included in central venous catheter placement apparatus for consenting patients, according to manufacturer directions
Other Name: Compass Vascular Access

Primary Outcome Measures :
  1. Operator Satisfaction [ Time Frame: 15 minutes ]
    Operator satisfaction (0-10 scale; 0=totally dissatisfied, 10=totally satisfied)

Secondary Outcome Measures :
  1. Arterial puncture incidence [ Time Frame: 15 minutes ]
    Incidence of arterial puncture

  2. Implement used at time of arterial puncture, if any [ Time Frame: 15 minutes ]
    Incidence of artery puncture with either needle, guidewire, or catheter

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting at University of New Mexico main/adult operating rooms who require central venous catheter (CVC) placement for perioperative care.

Inclusion Criteria:

  • BMI ≥35

Exclusion Criteria:

  • Pregnant women
  • Adults unable to consent
  • Non-English speakers
  • Prisoners

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03056859

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United States, New Mexico
University of New Mexico Hospital
Albuquerque, New Mexico, United States, 87106
Sponsors and Collaborators
University of New Mexico
Centurion Medical Products
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Principal Investigator: Neal Gerstein, MD University of New Mexico School of Medicine
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Responsible Party: Neal Gerstein, Associate Professor, University of New Mexico Identifier: NCT03056859    
Other Study ID Numbers: Compass Device Trial
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Deidentified study data may be shared with other researchers, pending final decision by study PI and sponsor
Keywords provided by Neal Gerstein, University of New Mexico:
Operator satisfaction with device