Blood Pressure
Conditions
Keywords
Operator satisfaction with device
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.
Interventions
DEVICEExtravascular blood pressure transducer
Listed device is included in central venous catheter placement apparatus for consenting patients, according to manufacturer directions
Sponsors
Centurion Medical Products
University of New Mexico
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* BMI ≥35
Exclusion criteria
* Pregnant women * Adults unable to consent * Non-English speakers * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operator Satisfaction | 15 minutes | Operator satisfaction (0-10 scale; 0=totally dissatisfied, 10=totally satisfied) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enrolled Patients Procedure: Central venous catheter placement with extravascular blood pressure transducer | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Enrolled Patients | — |
|---|---|---|
| Age, Continuous | 64 years | — |
| Body Mass Index | 39.6 kg/m^2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 20 participants | — |
| Sex: Female, Male Female | 10 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Operator Satisfaction
Operator satisfaction (0-10 scale; 0=totally dissatisfied, 10=totally satisfied)
Time frame: 15 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enrolled Patients | Operator Satisfaction | 8 score on a scale |
Secondary
Arterial Puncture Incidence
Incidence of arterial puncture
Time frame: 15 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enrolled Patients | Arterial Puncture Incidence | 0 Participants |
Secondary
Implement Used at Time of Arterial Puncture, if Any
If arterial puncture occurred, list catheterization implement being manipulated at the time
Time frame: 15 minutes
Population: There were no arterial punctures observed during the study.