Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 114 for:    centurion

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03056859
Recruitment Status : Recruiting
First Posted : February 17, 2017
Last Update Posted : November 12, 2018
Sponsor:
Collaborator:
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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 40 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
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : August 2019

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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


Contacts
Layout table for location contacts
Contact: Neal Gerstein, MD 5052722610 ngerstein@salud.unm.edu

Locations
Layout table for location information
United States, New Mexico
University of New Mexico Hospital Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Neal Gerstein, MD    505-272-2610    ngerstein@salud.unm.edu   
Sponsors and Collaborators
University of New Mexico
Centurion Medical Products
Investigators
Layout table for investigator information
Principal Investigator: Neal Gerstein, MD University of New Mexico School of Medicine

Layout table for additonal information
Responsible Party: Neal Gerstein, Associate Professor, University of New Mexico
ClinicalTrials.gov Identifier: NCT03056859     History of Changes
Other Study ID Numbers: Compass Device Trial
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 2018
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