Noninvasive Beat-to-Beat ClearSight Blood Pressure Monitoring



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:45 - Any
Updated:10/7/2018
Start Date:October 2016
End Date:September 2018

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The Role of Noninvasive Beat-to-Beat ClearSight Blood Pressure Monitoring During Non-cardiac Surgery

Subjects will first have a blood pressure reading recorded on both arms using a non-invasive
blood pressure monitoring (NIBP) cuff in the preoperative area. Then blood pressure will be
recorded using the ClearSight monitor on each hand over a one-minute period. If mean arterial
pressure (MAP) as assessed by either the noninvasive blood pressure (NIBP) monitoring cuff or
the ClearSight system differs by more than 10% from arm to arm, the subject will be excluded
from the study.

Before induction of anesthesia, the subject will be randomized to either:

ClearSight group + usual clinical care: Information from ClearSight monitor will be available
to the clinicians. According to ASA guidelines, usual blood pressure monitoring includes
non-invasive blood pressure measurements every 5 minutes during a surgical case.

Non-ClearSight group (blinded) + usual clinical care: Information from ClearSight monitor
will not be available to the clinicians.

Both patient groups will have continuous ClearSight monitoring and non-invasive blood
pressure monitoring every 5 minutes. The difference will be in the intervention group data
from the monitor will be available to the clinicians in the operating room, but in the
control group data from the ClearSight monitor will not be available (blinded) to the
clinicians. Regardless of the study group assignment, second-by-second ClearSight monitor
continuous blood pressure data will be recorded for each study patient and will be used for
analysis.

The morning of post-operative day 3 the subject will be given the QoR-15 questionnaire and
will complete POMS morbidity surveys.


Inclusion Criteria:

- Written informed consent

- Age > 45 years

- ASA Physical Status 3 or 4

- Moderate- or high-risk non-cardiac surgical procedures (i.e., orthopedic, spine,
urology, and general surgery) in patients in whom invasive blood pressure monitoring
is not planned

- Anticipated surgical duration >2 hours

Exclusion Criteria:

- Any contraindications to the proposed interventions

- Patient with invasive blood pressure monitoring

- Patients with contraindications to oscillometric blood pressure monitoring on one arm
and ClearSite monitoring on the other

- Preoperative discrepancy in mean arterial pressure >10% between the arms
We found this trial at
1
site
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Kamal Maheshwari, MD MPH
Phone: 216-444-9950
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