Effects of Steep Trendelenburg and Pneumoperitoneum on Cardiac Performance.
NCT ID: NCT06336746
Last Updated: 2024-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
80 participants
OBSERVATIONAL
2024-09-01
2025-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The extreme positioning of patients during robotic surgery in the pelvis, often 30 degrees head down tilting (Trendelenburg positioning), should increase the work load of the heart significantly. There are no studies concerning fragile patients with heart failure during these conditions.
In this study the circulatory effects in patients with normal heart function and preexisting heart failure will be studied during robotic surgery in extreme Trendelenburg positioning
During surgery the work load and performance of the heart will be monitored using an esophageal doppler and optical spectrophotometry measuring regional saturation of the brain. This study can identify patients at risk of developing critical circulatory failure during this type of surgery.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Positive End-expiratory Pressure-induced Increase in Central Venous Pressure as a Predictor of Fluid Responsiveness in Robot-assisted Laparoscopic Surgery
NCT02977143
Postspinal Hypotension and Cardiac Performance in the Elderly
NCT02978066
The Influence of Pneumoperitoneum on Minimal Invasive Cardiac Output Measurements
NCT01854307
Extravascular Lung Water and Pulmonary Vascular Permeability After Minimally Invasive Cardiac Surgery
NCT02155387
Assessment of Hemodynamic Response During Intubation Between Rigid Laryngoscopy and Track Light in Coronary Patients
NCT01682707
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The development of robotic-assisted laparoscopic surgery is rapid. It is at least more gentle than open surgery to the patient. During certain types of robotic-surgery i.e. prostatectomies and hysterectomies deep down in the small pelvis the surgeons need to tilt the patient in a steep Trendelenburg (30 degrees head down) position and insufflate CO2 (carbon dioxide) gas into the stomach to reach and visualize the organs properly.
According to the law of gravity this entails that the blood inside the vessels is pressed backwards against the pumping heart and afterload increases. To be able to withhold the flow of blood to our vital organs the performance of our heart is challenged. Besides carbon dioxide is blown into the stomach, which even more increases the workload of the heart. There is a substantial risk of acute heart failure during these manoeuvres especially in patients with preexisting heart failure.
There are very few studies investigating these problems. Earlier studies have only investigated the effects in healthy ASA (American Society of Anesthesiologists) 1-2 patients.
AIM:
This study will investigate how patients with known systolic heart failure manage this strain which is included in this new developing type of robotic surgery compared to patients with normal heart function.
METHOD:
1. Included patients undergo an echocardiographic investigation before surgery and will be classified in 2 groups: a) Normal systolic function b) Decreased systolic function defined as Ejection Fraction (EF) 45% or lower.
2. After start of anesthesia all patients receive an esophageal doppler and the output values of cardiac stroke volume (SV); cardiac Index (CI), systemic vascular resistance (SVR); pulse pressure variation(PPV), stroke Volume variation (SVV) Peak Velocity (PV)and Flow Time Corrected (FTc) are recorded as well as standard routine parameters during anesthesia. With INVOS (In Vivo Optical Spectroscopy) regional oxygen saturation of the front lobes of the brain is measured.
3. This procedure is repeated after start of Trendelenburg position 30 degrees head down, at the start of pneumoperitoneum and at the return to supine position.
4. The effects of robotic assisted surgery between patients with normal EF compared to patients with EF 45% or lower will be compared.
THE IMPORTANCE OF THIS STUDY:
The increasing field of robotic-assisted surgery, which often results in shorter and less complicated postoperative care will enable older and more fragile patients to be available for surgery. In contrast these patients encounter new cardiovascular challenges during the anesthesia and extreme positioning surgery.
It is therefore most important to be aware of these physiological challenges and how to handle them. This study will also show which patients are not suitable for robotic surgery.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients with Preoperative EF: 50% or higher
Patients included will be examined with Transthoracic Echocardiography preoperatively and Ejection Fraction (EF) measured.
Esophageal Doppler
Esophageal Doppler: measuring cardiac performance. INVOS: measuring regional saturation of the brain.
Patients with Preoperative EF: 45% or lower
Patients included will be examined with Transthoracic Echocardiography preoperatively and Ejection Fraction (EF) measured.
Esophageal Doppler
Esophageal Doppler: measuring cardiac performance. INVOS: measuring regional saturation of the brain.
Patients without intrathecal bupivacain and morphine.
The routine is that all patient receive an intrathecal injection of morphine and bupivacain before start of anesthesia. Patients who have contraindications for spinal anesthesia will be collected in this group.
Esophageal Doppler
Esophageal Doppler: measuring cardiac performance. INVOS: measuring regional saturation of the brain.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Esophageal Doppler
Esophageal Doppler: measuring cardiac performance. INVOS: measuring regional saturation of the brain.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
\-
Exclusion Criteria
2. Dementia,
3. Not able to give written consent -
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Karlstad Central Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ragnar Henningsson
Associate Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dpt of Anesthesiology&Intensive Care; Central Hospital of Karlstad
Karlstad, Värmland County, Sweden
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RHenningsson
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.