Compass Device CVC Trial

Central Venous Catheterization in Obese Patients With Compass Device

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • University of New Mexico Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

Inclusion Criteria:

• BMI ≥35

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: Compass Vascular Access

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operator Satisfaction	Operator satisfaction (0-10 scale; 0=totally dissatisfied, 10=totally satisfied)	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial Puncture Incidence	Incidence of arterial puncture	15 minutes
Implement Used at Time of Arterial Puncture, if Any	If arterial puncture occurred, list catheterization implement being manipulated at the time	15 minutes

Collaborators and Investigators

• Sponsor: University of New Mexico
• Collaborators: Centurion Medical Products
• Investigators: Principal Investigator: Neal Gerstein, MD, University of New Mexico School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2017
• Primary Completion (Actual): February 10, 2020
• Study Completion (Actual): February 10, 2020

Study Registration Dates

• First Submitted: February 14, 2017
• First Submitted That Met QC Criteria: February 16, 2017
• First Posted (Actual): February 17, 2017

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Operator satisfaction with device
• Other Study ID Numbers: Compass Device Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Deidentified study data may be shared with other researchers, pending final decision by study PI and sponsor