Heart performance during steep head-down positioning for robotic pelvic surgery
Effects of Steep Trendelenburg and Pneumoperitoneum on Cardiac Performance During Robotic-assisted Surgery in Patients With Normal and Low Ejection Fraction.
Karlstad Central Hospital · NCT06336746
This test looks at how heart function changes during steep head-down tilt in people having robotic pelvic surgery, including those with and without systolic heart failure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karlstad Central Hospital (other) |
| Locations | 1 site (Karlstad, Värmland County) |
| Trial ID | NCT06336746 on ClinicalTrials.gov |
What this trial studies
Consecutive adults scheduled for robotic pelvic procedures with steep Trendelenburg positioning will have a preoperative echocardiogram to classify systolic function and then be monitored perioperatively. Hemodynamic monitoring uses an esophageal Doppler while regional cerebral saturation is tracked with optical spectrophotometry during insufflation and head-down tilt. Patients with normal systolic function will be compared to patients with known systolic heart failure to describe circulatory responses. This is an observational single-center protocol at Karlstad Central Hospital without interventional treatment changes driven by the study.
Who should consider this trial
Good fit: Adults scheduled for robotic pelvic surgery requiring steep Trendelenburg positioning who can give written informed consent, including those with known systolic heart failure and those with normal heart function.
Not a fit: People under 18, those unable to give written consent, patients not undergoing robotic Trendelenburg procedures, or patients with only diastolic dysfunction are unlikely to benefit from the results directly.
Why it matters
Potential benefit: If successful, the findings could help anesthesiologists better anticipate and manage heart stress during robotic surgery and reduce perioperative cardiac complications.
How similar studies have performed: Very few prior studies exist and they were limited to healthy ASA 1–2 patients, so application in patients with systolic heart failure is largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1\. Consecutive Patients Scheduled for Robotic Surgery with Trendelenburg positioning. \- Exclusion Criteria: 1. Age \<18; 2. Dementia, 3. Not able to give written consent -
Where this trial is running
Karlstad, Värmland County
- Dpt of Anesthesiology&Intensive Care; Central Hospital of Karlstad — Karlstad, Värmland County, Sweden (RECRUITING)
Study contacts
- Study coordinator: Ragnar N Henningsson, Associate Professor
- Email: ragnar.henningsson@regionvarmland.se
- Phone: +46108317434
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.
Conditions: Heart Failure, Systolic, Robotic Surgery