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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

Tracking Information
First Submitted Date February 14, 2017
First Posted Date February 17, 2017
Last Update Posted Date March 25, 2020
Actual Study Start Date February 17, 2017
Actual Primary Completion Date February 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 16, 2017)
Operator Satisfaction [ Time Frame: 15 minutes ]
Operator satisfaction (0-10 scale; 0=totally dissatisfied, 10=totally satisfied)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 16, 2017)
  • Arterial puncture incidence [ Time Frame: 15 minutes ]
    Incidence of arterial puncture
  • Implement used at time of arterial puncture, if any [ Time Frame: 15 minutes ]
    Incidence of artery puncture with either needle, guidewire, or catheter
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Compass Device CVC Trial
Official Title Central Venous Catheterization in Obese Patients With Compass Device
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.
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Blood Pressure
Intervention 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
Study Groups/Cohorts Enrolled Patients
Procedure: Central venous catheter placement with extravascular blood pressure transducer
Intervention: Device: Extravascular blood pressure transducer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 24, 2020)
20
Original Estimated Enrollment
 (submitted: February 16, 2017)
40
Actual Study Completion Date February 10, 2020
Actual Primary Completion Date February 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • BMI ≥35

Exclusion Criteria:

  • Pregnant women
  • Adults unable to consent
  • Non-English speakers
  • Prisoners
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03056859
Other Study ID Numbers Compass Device Trial
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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
Responsible Party Neal Gerstein, University of New Mexico
Study Sponsor University of New Mexico
Collaborators Centurion Medical Products
Investigators
Principal Investigator: Neal Gerstein, MD University of New Mexico School of Medicine
PRS Account University of New Mexico
Verification Date March 2020