Heart Failure, SystolicNCT06336746
Cardiac Performance During Steep Trendelenburg Position in Patients Undergoing Robotic Surgery Surgery.
An observational study of Heart Failure, Systolic and Robotic Surgery, run by Karlstad Central Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Systolic, Robotic Surgery
- What is being tested?
- Esophageal Doppler
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- 21 Nov 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutive Patients scheduled for robotic surgery in Tendelenburg positioning.
Who may be able to join
- 1. Consecutive Patients Scheduled for Robotic Surgery with Trendelenburg positioning.
- -
Who cannot join
- Age <18;
- Dementia,
- Not able to give written consent -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ann-Sofie Lorentzon, ND contact
Sweden1 site, 1 recruiting
- Recruiting
Dpt of Anesthesiology&Intensive Care; Central Hospital of Karlstad
Karlstad, Värmland County, 65230
Ragnar N Henningsson, Associate Professor, +461083317434, ragnar.henningsson@regionvarmland.se
About this study
Official title: Effects of Steep Trendelenburg and Pneumoperitoneum on Cardiac Performance During Robotic-assisted Surgery in Patients With Normal and Low Ejection Fraction.
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.
Read more
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.
Read the 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 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:
- 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.
- 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.
- 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.
- 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
- Heart Failure, Systolic, Robotic Surgery
- Being tested
- Esophageal Doppler
- Medical subject headings
- Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal DopplerDevice
Also called InVivo Optical Spectroscopy INVOS
Esophageal Doppler: measuring cardiac performance. INVOS: measuring regional saturation of the brain.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Preoperative EF: 50% or higher | Patients included will be examined with Transthoracic Echocardiography preoperatively and Ejection Fraction (EF) measured. Receives: Device: Esophageal Doppler | |
| Patients with Preoperative EF: 45% or lower | Patients included will be examined with Transthoracic Echocardiography preoperatively and Ejection Fraction (EF) measured. Receives: Device: Esophageal Doppler | |
| 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. Receives: Device: Esophageal Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Stroke Volume during Trendelenburg position and pneumoperitoneum.
Esophageal Doppler Monitoring
Measured: During 15 minutes after reaching position.
Secondary outcomes (2)
% Change of Systemic Vascular Resistance;PulsePressureVariation; Peak Velocity; Stroke Volume Variation and FlowTimeCorrected
Esophageal Doppler Monitoring
Measured: During 15 minutes after reaching position
% change in regional brain saturation rSO2 during Trendelenburg position and pneumooperitoneum.
INVivoOpticalSpectroscopy
Measured: During 15 min after reaching position.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start21 Nov 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, SystolicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karlstad Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ragnar Henningsson, Karlstad Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336746
- Sponsor's protocol ID
- RHenningsson
- Status last verified
- Feb 2026
- First submitted
- 12 Dec 2023
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Steep Trendelenburg and Pneumoperitoneum on Cardiac Performance During Robotic-assisted Surgery in Patients With Normal and Low Ejection Fraction.
- ClinicalTrials.gov ID
- NCT06336746
- Acronym / sponsor ID
- RHenningsson
- Conditions
- Heart Failure, Systolic, Robotic Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Karlstad Central HospitalUniversity, hospital or other
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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:
- 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.
- 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.
- 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.
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with Preoperative EF: 50% or higher | – | Device: Esophageal DopplerPatients included will be examined with Transthoracic Echocardiography preoperatively and Ejection Fraction (EF) measured. |
| Patients with Preoperative EF: 45% or lower | – | Device: Esophageal DopplerPatients included will be examined with Transthoracic Echocardiography preoperatively and Ejection Fraction (EF) measured. |
| Patients without intrathecal bupivacain and morphine. | – | Device: Esophageal DopplerThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive Patients scheduled for robotic surgery in Tendelenburg positioning.
Key inclusion criteria (2 listed)
- 1. Consecutive Patients Scheduled for Robotic Surgery with Trendelenburg positioning.
- -
Key exclusion criteria (3 listed)
- Age <18;
- Dementia,
- Not able to give written consent -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esophageal DopplerAlso: InVivo Optical Spectroscopy INVOSEsophageal Doppler: measuring cardiac performance. INVOS: measuring regional saturation of the brain. | Device | Patients with Preoperative EF: 45% or lower, Patients with Preoperative EF: 50% or higher, Patients without intrathecal bupivacain and morphine. |
Primary outcome
Change of Stroke Volume during Trendelenburg position and pneumoperitoneum.
Time frame: During 15 minutes after reaching position.
Esophageal Doppler Monitoring
2 secondary outcomes
% Change of Systemic Vascular Resistance;PulsePressureVariation; Peak Velocity; Stroke Volume Variation and FlowTimeCorrected
Time frame: During 15 minutes after reaching position
% change in regional brain saturation rSO2 during Trendelenburg position and pneumooperitoneum.
Time frame: During 15 min after reaching position.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ann-Sofie Lorentzon, ND contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, Systolic and Robotic Surgery, run by Karlstad Central Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ragnar N Henningsson, Associate Professor (+46108317434, ragnar.henningsson@regionvarmland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Stroke Volume during Trendelenburg position and pneumoperitoneum. (time frame: During 15 minutes after reaching position.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.