NCT03056859

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

February 17, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2020

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

June 27, 2024

Completed
Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

3 years

First QC Date

February 14, 2017

Results QC Date

January 4, 2024

Last Update Submit

June 25, 2024

Conditions

Keywords

Operator satisfaction with device

Outcome Measures

Primary Outcomes (1)

  • Operator Satisfaction

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

    15 minutes

Secondary Outcomes (2)

  • Arterial Puncture Incidence

    15 minutes

  • Implement Used at Time of Arterial Puncture, if Any

    15 minutes

Study Arms (1)

Enrolled Patients

Procedure: Central venous catheter placement with extravascular blood pressure transducer

Device: Extravascular blood pressure transducer

Interventions

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

Also known as: Compass Vascular Access
Enrolled Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • BMI ≥35

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico Hospital

Albuquerque, New Mexico, 87106, United States

Location

Results Point of Contact

Title
Research Officer
Organization
University of New Mexico Anesthesiology Department

Study Officials

  • Neal Gerstein, MD

    University of New Mexico School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 14, 2017

First Posted

February 17, 2017

Study Start

February 17, 2017

Primary Completion

February 10, 2020

Study Completion

February 10, 2020

Last Updated

June 27, 2024

Results First Posted

June 27, 2024

Record last verified: 2024-06

Locations