Predicting low blood pressure during shoulder surgery in beach chair position
Effect of the Hypotension Prediction Index on the Prevalence of Intra-operative Hypotension During Shoulder Surgery in Beach Chair: A Prospective Randomized Clinical Trial.
This study is testing a new software that helps doctors predict low blood pressure during shoulder surgeries done while sitting in a beach chair position to keep patients safe and comfortable.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT06120296 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the Acumen Hypotension Prediction Index (HPI) software in predicting hypotension during shoulder surgeries performed in the beach chair position. The HPI aims to alert anesthesiologists to potential drops in blood pressure before they occur, allowing for timely interventions. The study will involve patients undergoing general anesthesia combined with an interscalene block, with specific inclusion and exclusion criteria to ensure participant safety. The goal is to improve patient outcomes by preventing hypotension during these procedures.
Who should consider this trial
Good fit: Ideal candidates include patients with a BMI under 40, who can provide informed consent and are classified as ASA I-IV.
Not a fit: Patients with pre-existing hypotension, a history of stroke, or contraindications for the required anesthesia techniques may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of hypotension during shoulder surgeries, enhancing patient safety and recovery.
How similar studies have performed: Previous studies have shown the effectiveness of the HPI in various surgical settings, but this specific application in shoulder surgery has not yet been tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * BMI \< 40 kg/m2 * Patient can give informed consent * ASA I-IV * Invasive blood monitoring * General anesthesia combined with interscalene block Exclusion Criteria: * - Refusal of participation * Hypotension before surgery (MAP\< 65 mmHg) * History of stroke * Dementia * Contra-indication for interscalene block * Contra-indication for general anesthesia * Dialysis
Where this trial is running
Leuven
- Anesthesie Research — Leuven, Belgium (Recruiting)
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.