SMART TRENDS Study (NCT05957406) | Clinical Trial Compass
CompletedNot Applicable
SMART TRENDS Study
United States296 participantsStarted 2023-07-11
Plain-language summary
A multicenter, interventional, feasibility comparison with historical controls
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Signed informed consent
* Age ≥ 18 years
* ASA Physical Status ≥ 2
* Elective noncardiac surgery with expected surgery duration ≥ 3 hours and expected post-operative length of stay of ≥ 3 days
* Planned monitoring with an arterial catheter; Cohort 2: without planned arterial catheter insertion
* General anesthesia with tracheal intubation and positive pressure ventilation
Exclusion Criteria:
* Inability to comply with the study intra-operative hemodynamic management algorithm such as surgeon request for relative hypotension or fluid restriction or avoidance of vasopressors
* Planned vasopressor or inotrope infusion during surgery
* Contraindication to intra-arterial blood pressure monitoring
* Has previously participated in the SMART TRENDS study
* Serum creatine \> 2.0 mg/dL (\> 175 μmol/L) or CKD stage \> 3A
* Scheduled for intracranial or cardiac surgery
* Patient who is known to be pregnant
* Patients on mechanical circulatory support
* Emergency surgery
* Planned beach-chair positioning
Additional Exclusion Criteria for Cohort 2 only:
* Extreme contraction of the smooth muscle in the arteries and arterioles of the lower arm and hand, such as may be present in patients with Raynaud's disease
* Finger or hand deformity that prevents proper placement of finger cuff by visual inspection
* Inability to place Acumen IQ finger cuffs due to subject anatomy, condition, or obstructive paraphernalia (such as false nails)
What they're measuring
1
HPI Smart Alert
Timeframe: From start to end of non-cardiac surgery