Compass Device CVC Trial

Completed

• Conditions: Blood Pressure
• Interventions: Device: Extravascular blood pressure transducer

• Registration Number: NCT03056859
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-02-14
• Study First Submitted QC: 2017-02-16
• Study Start: 2017-02-17
• Study First Posted: 2017-02-17
• Primary Completion: 2020-02-10
• Study Completion: 2020-02-10
• Results First Submitted: 2024-01-04
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-25
• Last Update Submitted: 2024-06-25
• Results First Posted: 2024-06-27
• Last Update Posted: 2024-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• BMI ≥35

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Enrolled Patients	Extravascular blood pressure transducer	Procedure: Central venous catheter placement with extravascular blood pressure transducer

Primary Outcome Measures

Name	Time	Method
Operator Satisfaction	15 minutes	Operator satisfaction (0-10 scale; 0=totally dissatisfied, 10=totally satisfied)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of New Mexico Hospital; 🇺🇸 Albuquerque, New Mexico, United States