Noninvasive Beat-to-Beat ClearSight Blood Pressure Monitoring

October 4, 2018 updated by: Kamal Maheshwari, MD MPH, The Cleveland Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ClearSight device
Patients having orthopedic, urologic or general surgery will have blood pressure monitored by the ClearSight device second by second throughout surgery.
Procedure: 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
Sham Comparator: 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.
Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time- weighted average (TWA) MAP
Time Frame: 2 hours
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

August 16, 2016

First Submitted That Met QC Criteria

August 16, 2016

First Posted (Estimate)

August 19, 2016

Study Record Updates

Last Update Posted (Actual)

October 5, 2018

Last Update Submitted That Met QC Criteria

October 4, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-845

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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