Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centurion Medical Products | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enrolled Patients | Procedure: Central venous catheter placement with extravascular blood pressure transducer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extravascular blood pressure transducer | Device | Listed device is included in central venous catheter placement apparatus for consenting patients, according to manufacturer directions |
| Measure | Description | Time Frame |
|---|---|---|
| Operator Satisfaction | Operator satisfaction (0-10 scale; 0=totally dissatisfied, 10=totally satisfied) | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial Puncture Incidence | Incidence of arterial puncture | 15 minutes |
| Implement Used at Time of Arterial Puncture, if Any | If arterial puncture occurred, list catheterization implement being manipulated at the time |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients presenting at University of New Mexico main/adult operating rooms who require central venous catheter (CVC) placement for perioperative care.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Neal Gerstein, MD | University of New Mexico School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico Hospital | Albuquerque | New Mexico | 87106 | United States |
Deidentified study data may be shared with other researchers, pending final decision by study PI and sponsor
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Enrolled Patients | Procedure: Central venous catheter placement with extravascular blood pressure transducer |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Enrolled Patients | Procedure: Central venous catheter placement with extravascular blood pressure transducer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Operator Satisfaction | Operator satisfaction (0-10 scale; 0=totally dissatisfied, 10=totally satisfied) | Posted | Median | Inter-Quartile Range | score on a scale | 15 minutes |
|
|
One hour
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enrolled Patients | Procedure: Central venous catheter placement with extravascular blood pressure transducer |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Officer | University of New Mexico Anesthesiology Department | 505-272-2610 | HSC-Anesthesiology@salud.unm.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 14, 2017 | Jun 25, 2024 | Prot_000.pdf |
Not provided
Not provided
Not provided
Not provided
|
| 15 minutes |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Median | Inter-Quartile Range | kg/m^2 |
|
|
| Secondary | Arterial Puncture Incidence | Incidence of arterial puncture | Posted | Count of Participants | Participants | 15 minutes |
|
|
|
| Secondary | Implement Used at Time of Arterial Puncture, if Any | If arterial puncture occurred, list catheterization implement being manipulated at the time | There were no arterial punctures observed during the study. | Posted | 15 minutes |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
Not provided
Not provided
Not provided