An interventional study of Orthopedic, urologic or general surgery in Hypotension, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2018-10-05.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Prevention
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.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's enrollment of 320 is above the median of 80 across 675 interventional studies indexed under Hypotension.
Browse Hypotension studies →The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.
Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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
Time- weighted average (TWA) MAP
Time frame: 2 hours
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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