Comparing two methods of blood pressure monitoring during surgery
Continuous Invasive Versus 1-min Interval Oscillometric Arterial Pressure Monitoring and Hypotension During Induction of Anesthesia: a Bicenter, Randomized, Noninferiority Trial
This study tests whether continuous blood pressure monitoring during surgery can help prevent low blood pressure better than checking it every minute in adults having non-cardiac surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 244 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 2 sites (Seoul and 1 other locations) |
| Trial ID | NCT05792436 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of continuous arterial blood pressure monitoring versus a 1-minute interval oscillometric method during the induction of general anesthesia in adult patients undergoing non-cardiac surgery. It aims to address the common occurrence of hypotension during surgery, particularly from anesthesia induction to skin incision. By comparing these two monitoring techniques, the study seeks to determine if continuous monitoring can significantly reduce the incidence of hypotension compared to intermittent measurements. The study involves adult patients who will receive either method of blood pressure monitoring during their surgical procedure.
Who should consider this trial
Good fit: Ideal candidates are adult patients aged 19 or older undergoing scheduled non-cardiac surgery with general anesthesia requiring continuous invasive arterial blood pressure monitoring.
Not a fit: Patients who may not benefit include those requiring arterial access before anesthesia induction or those undergoing emergency surgeries.
Why it matters
Potential benefit: If successful, this study could lead to improved management of blood pressure during surgery, potentially reducing the risk of hypotension-related complications.
How similar studies have performed: Previous studies have shown that continuous arterial pressure monitoring can significantly reduce hypotension during anesthesia induction, suggesting a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients aged 19 or older undergoing scheduled non-cardiac surgery with general anesthesia and continuous invasive arterial blood pressure monitoring via the radial artery Exclusion Criteria: * Arterial access is clinically necessary before induction of anesthesia (e.g., moderate or higher degree of aortic stenosis, moderate or higher degree of heart failure, coronary artery disease requiring revascularization, intracranial aneurysm with a significant risk of rupture, etc.) * Emergency surgery * American Society of Anesthesiologists (ASA) physical status 5 or 6 * Arterial access is required in a different artery other than the radial artery (e.g., the femoral artery) * Electrocardiogram other than sinus rhythm * Refusal to participate in the study
Where this trial is running
Seoul and 1 other locations
- Seoul National University Hospital — Seoul, Korea, Republic of (Recruiting)
- Korea University Guro Hospital — Seoul, Korea, Republic of (Not_yet_recruiting)
Study contacts
- Study coordinator: Karam Nam, MD
- Email: karamnam@gmail.com
- Phone: 82-2-2072-0643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.