Noninvasive Beat-to-Beat ClearSight Blood Pressure Monitoring

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ClearSight device

Patients having orthopedic, urologic or general surgery will have blood pressure monitored by the ClearSight device second by second throughout surgery.

Group Type EXPERIMENTAL

Orthopedic, urologic or general surgery

Intervention Type PROCEDURE

Patients having orthopedic, urologic or general surgery may have the ClearSight device; patients having orthopedic, urologic or general surgery may have the non-ClearSight device to monitor subject blood pressure during surgery

Non-ClearSight

Patients having orthopedic, urologic or general surgery will have blood pressure monitored by the Non-ClearSight (the clinical team) every 5 minutes throughout surgery.

Group Type SHAM_COMPARATOR

Orthopedic, urologic or general surgery

Intervention Type PROCEDURE

Patients having orthopedic, urologic or general surgery may have the ClearSight device; patients having orthopedic, urologic or general surgery may have the non-ClearSight device to monitor subject blood pressure during surgery

Interventions

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Orthopedic, urologic or general surgery

Patients having orthopedic, urologic or general surgery may have the ClearSight device; patients having orthopedic, urologic or general surgery may have the non-ClearSight device to monitor subject blood pressure during surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No