Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06336746
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2023-12-12
Brief Title:
Effects of Steep Trendelenburg and Pneumoperitoneum on Cardiac Performance
Sponsor:
Karlstad Central Hospital
Organization:
Karlstad Central Hospital
Study Overview
Official Title:
Effects of Steep Trendelenburg and Pneumoperitoneum on Cardiac Performance During Robotic-assisted Surgery in Patients With Normal and Low Ejection Fraction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The field of robotic-assisted laparoscopic surgery increases all the time Older and more fragile patients which are not suitable for major open surgery could be scheduled for robotic- assisted surgery The peroperative anesthesiological challenges and stresses during this type of surgery could anyway be even more prominent
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
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
Detailed Description:
BACKGROUND
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 ie 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 variationPPV stroke Volume variation SVV Peak Velocity PVand 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
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 ie 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 variationPPV stroke Volume variation SVV Peak Velocity PVand 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None