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OpenTrials
Completed

NCT Number: NCT02872896

Noninvasive Beat-to-Beat ClearSight Blood Pressure Monitoring

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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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orthopedic, urologic or general surgery

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

Primary outcomes

  1. Time- weighted average (TWA) MAP

    Time frame: 2 hours

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 19, 2016
Registry last updated
Oct 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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