Compass Device CVC Trial

Blood Pressure Clinical Trial

Official title:

Central Venous Catheterization in Obese Patients With Compass Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03056859
• Other study ID #: Compass Device Trial
• Status: Completed
• Start date: February 17, 2017
• Est. completion date: February 10, 2020

Study information

• Verified date: March 2020
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 10, 2020
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• BMI =35

Exclusion Criteria:

• Pregnant women

• Adults unable to consent

• Non-English speakers

• Prisoners

Related Conditions & MeSH terms

• 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

Locations

Country	Name	City	State
United States	University of New Mexico Hospital	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	Centurion Medical Products

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operator Satisfaction	Operator satisfaction (0-10 scale; 0=totally dissatisfied, 10=totally satisfied)	15 minutes
Secondary	Arterial puncture incidence	Incidence of arterial puncture	15 minutes
Secondary	Implement used at time of arterial puncture, if any	Incidence of artery puncture with either needle, guidewire, or catheter	15 minutes