Bariatric Surgery
Conditions
Brief summary
This study will compare accuracy of a newly developed monitor for continuous non-invasive blood pressure monitoring (CNAP™ Monitor 500; CNSystems Medizintechnik AG, Graz, Austria) that provides beat-to-beat BP readings with two of the current and more commonly used intermittently oscillometric non-invasive blood pressure device (NIBP), and the invasive arterial line (IBP).
Interventions
DEVICECNAP monitor
Patients undergoing bariatric surgery and being monitored using the CNAP monitor.
Sponsors
Joseph D. Tobias
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients who are scheduled for laparoscopic bariatric surgery for the treatment of obesity * Patients in whom an indwelling arterial cannula will be placed for the surgical procedure
Exclusion criteria
* Patients with history of a peripheral neurologic or neuropathic disorder * Patients in whom an invasive arterial cannula cannot be placed * Patients with vascular implants at the sites of non-invasive blood pressure measurement (fingers and upper arm of the examined arm) * Edematous patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Absolute Difference in Mean Arterial Pressure Between the Arterial Catheter and the CNAP. | Participants will be followed for the duration of surgery, an expected average of 2 hours. | To avoid biasing the data, the absolute, not directional, difference was used. For example, if the reading from the CNAP device was 10 mmHg above or below the reading from the AC, a value of 10 mmHg was used, not -10 or +10 mmHg. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CNAP Monitor Subjects undergoing bariatric surgery and monitored using the CNAP monitor.
CNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor. | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | CNAP Monitor |
|---|---|
| Age, Categorical <=18 years | 12 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age, Continuous | 17.55 years STANDARD_DEVIATION 2.53 |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
The Absolute Difference in Mean Arterial Pressure Between the Arterial Catheter and the CNAP.
To avoid biasing the data, the absolute, not directional, difference was used. For example, if the reading from the CNAP device was 10 mmHg above or below the reading from the AC, a value of 10 mmHg was used, not -10 or +10 mmHg.
Time frame: Participants will be followed for the duration of surgery, an expected average of 2 hours.
Population: The initial study cohort included 21 patients; however, the finger cuff was expired in 1 patient, resulting in no data collection, and the data from 2 other patients were lost in the download to the electronic medical record system.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CNAP Monitor | The Absolute Difference in Mean Arterial Pressure Between the Arterial Catheter and the CNAP. | 7.7 mmHg | Standard Deviation 4.9 |