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Completed

NCT Number: NCT03056859

Compass Device CVC Trial

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.

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Key information

Conditions

Blood Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of New Mexico Hospital

Albuquerque, New Mexico, 87106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI ≥35

Exclusion criteria

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

Treatment and study plan

Extravascular blood pressure transducer

Device

Listed device is included in central venous catheter placement apparatus for consenting patients, according to manufacturer directions

Other names: Compass Vascular Access

Primary outcomes

  1. Operator Satisfaction

    Time frame: 15 minutes

    Operator satisfaction (0-10 scale; 0=totally dissatisfied, 10=totally satisfied)

Secondary outcomes

  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

    If arterial puncture occurred, list catheterization implement being manipulated at the time

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Collaborators

  • Centurion Medical Products

Registry information

Official study title

Central Venous Catheterization in Obese Patients With Compass Device

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 17, 2017
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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