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Noninvasive Beat-to-Beat ClearSight Blood Pressure Monitoring

Primary Purpose

Hypotension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Orthopedic, urologic or general surgery
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypotension

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

ClearSight device

Non-ClearSight

Arm Description

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

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

Outcomes

Primary Outcome Measures

Time- weighted average (TWA) MAP

Secondary Outcome Measures

Full Information

First Posted
August 16, 2016
Last Updated
October 4, 2018
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02872896
Brief Title
Noninvasive Beat-to-Beat ClearSight Blood Pressure Monitoring
Official Title
The Role of Noninvasive Beat-to-Beat ClearSight Blood Pressure Monitoring During Non-cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ClearSight device
Arm Type
Experimental
Arm Description
Patients having orthopedic, urologic or general surgery will have blood pressure monitored by the ClearSight device second by second throughout surgery.
Arm Title
Non-ClearSight
Arm Type
Sham Comparator
Arm Description
Patients having orthopedic, urologic or general surgery will have blood pressure monitored by the Non-ClearSight (the clinical team) every 5 minutes throughout surgery.
Intervention Type
Procedure
Intervention Name(s)
Orthopedic, urologic or general surgery
Intervention Description
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
Primary Outcome Measure Information:
Title
Time- weighted average (TWA) MAP
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Sessler, M.D.
Organizational Affiliation
Department Chair
Official's Role
Study Chair
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31989416
Citation
Maheshwari K, Buddi S, Jian Z, Settels J, Shimada T, Cohen B, Sessler DI, Hatib F. Performance of the Hypotension Prediction Index with non-invasive arterial pressure waveforms in non-cardiac surgical patients. J Clin Monit Comput. 2021 Feb;35(1):71-78. doi: 10.1007/s10877-020-00463-5. Epub 2020 Jan 27.
Results Reference
derived
PubMed Identifier
29916861
Citation
Maheshwari K, Khanna S, Bajracharya GR, Makarova N, Riter Q, Raza S, Cywinski JB, Argalious M, Kurz A, Sessler DI. A Randomized Trial of Continuous Noninvasive Blood Pressure Monitoring During Noncardiac Surgery. Anesth Analg. 2018 Aug;127(2):424-431. doi: 10.1213/ANE.0000000000003482.
Results Reference
derived

Learn more about this trial

Noninvasive Beat-to-Beat ClearSight Blood Pressure Monitoring

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