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Compass Device CVC Trial

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ClinicalTrials.gov Identifier: NCT03056859
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : March 25, 2020
Sponsor:
Collaborator:
Centurion Medical Products
Information provided by (Responsible Party):
Neal Gerstein, University of New Mexico

Study Description
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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.
Study Design
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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
Groups and Cohorts
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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


Outcome Measures
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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


Eligibility Criteria
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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.
Criteria

Inclusion Criteria:

  • BMI ≥35

Exclusion Criteria:

  • Pregnant women
  • Adults unable to consent
  • Non-English speakers
  • Prisoners
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03056859


Locations
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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
Investigators
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Principal Investigator: Neal Gerstein, MD University of New Mexico School of Medicine
More Information
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Responsible Party: Neal Gerstein, Associate Professor, University of New Mexico
ClinicalTrials.gov 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