Blood PressureNCT03056859
Compass Device CVC Trial
An observational study of Blood Pressure, run by University of New Mexico at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Extravascular blood pressure transducer
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2017to 10 Feb 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting at University of New Mexico main/adult operating rooms who require central venous catheter (CVC) placement for perioperative care.
Who may be able to join
- BMI ≥35
Who cannot join
- Pregnant women
- Adults unable to consent
- Non-English speakers
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Hospital
Albuquerque, New Mexico, 87106
About this study
Official title: 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.
Read the 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.
- Conditions
- Blood Pressure
- Being tested
- Extravascular blood pressure transducer
- Keywords
- Operator satisfaction with device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extravascular blood pressure transducerDevice
Also called Compass Vascular Access
Listed device is included in central venous catheter placement apparatus for consenting patients, according to manufacturer directions
| Study group | Role | What they receive |
|---|---|---|
| Enrolled Patients | Procedure: Central venous catheter placement with extravascular blood pressure transducer Receives: Device: Extravascular blood pressure transducer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operator Satisfaction
Operator satisfaction (0-10 scale; 0=totally dissatisfied, 10=totally satisfied)
Measured: 15 minutes
Secondary outcomes (2)
Arterial Puncture Incidence
Incidence of arterial puncture
Measured: 15 minutes
Implement Used at Time of Arterial Puncture, if Any
If arterial puncture occurred, list catheterization implement being manipulated at the time
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study start17 Feb 2017
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Centurion Medical Products
- Responsible party
- Principal investigator, Neal Gerstein, University of New Mexico
- Investigators
- Neal Gerstein, MD, Principal investigator, University of New Mexico School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056859
- Sponsor's protocol ID
- Compass Device Trial
- Status last verified
- Jun 2024
- First submitted
- 14 Feb 2017
- Last updated
- 27 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Deidentified study data may be shared with other researchers, pending final decision by study PI and sponsor
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Venous Catheterization in Obese Patients With Compass Device
- ClinicalTrials.gov ID
- NCT03056859
- Acronym / sponsor ID
- Compass Device Trial
- Conditions
- Blood Pressure
- Keywords
- Operator satisfaction with device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- Centurion Medical Products
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 17 Feb 2017 (actual)
- Results
- Posted 27 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled Patients | – | Device: Extravascular blood pressure transducerProcedure: Central venous catheter placement with extravascular blood pressure transducer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting at University of New Mexico main/adult operating rooms who require central venous catheter (CVC) placement for perioperative care.
Key inclusion criteria (1 listed)
- BMI ≥35
Key exclusion criteria (4 listed)
- Pregnant women
- Adults unable to consent
- Non-English speakers
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extravascular blood pressure transducerAlso: Compass Vascular AccessListed device is included in central venous catheter placement apparatus for consenting patients, according to manufacturer directions | Device | Enrolled Patients |
Primary outcome
Operator Satisfaction
Time frame: 15 minutes
Operator satisfaction (0-10 scale; 0=totally dissatisfied, 10=totally satisfied)
2 secondary outcomes
Arterial Puncture Incidence
Time frame: 15 minutes
Implement Used at Time of Arterial Puncture, if Any
Time frame: 15 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Deidentified study data may be shared with other researchers, pending final decision by study PI and sponsor
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neal Gerstein, MD principal investigator
University of New Mexico School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operator Satisfaction (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024; AzTrials last refreshed its copy on 29 Oct 2026.