Perfusion IndexNCT06351241
Hemodynamic Effects of Steep Trendelenburg Position and Pneumoperitoneum
An observational study of Perfusion Index and Pleth Variability Index, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
BACKGROUND: The steep Trendelenburg position and pneumoperitoneum are used to improve surgical visibility in robot-assisted laparoscopic radical prostatectomy (RALRP). However, these procedures can lead to hemodynamic changes. Read more about this study
- Who is it for?
- Ages 25 to 80 years, men only
- Conditions the study is for
- Perfusion Index, Pleth Variability Index
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Nov 2022to 14 Apr 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 25 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients belonging to ASA classes I-II, aged between 25 and 80 years, and scheduled for elective robot-assisted laparoscopic radical prostatectomy under general anesthesia were included in the study. Patients deemed suitable for the study were explained about the study, and written voluntary informed consent for participation was obtained.
Who may be able to join
- Patients belonging to ASA classes I-II
- Aged between 25 and 80 years
- Elective robot-assisted laparoscopic radical prostatectomy under general anesthesia
Who cannot join
- conversion to open surgery
- patients with an ASA score above III
- unsuitable for robotic surgery
- who developed hemodynamic instability or respiratory complications during the intraoperative period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemodynamic Effects of Steep Trendelenburg Position and Pneumoperitoneum in Urologic Robotic Surgery: a Prospective Study
BACKGROUND: The steep Trendelenburg position and pneumoperitoneum are used to improve surgical visibility in robot-assisted laparoscopic radical prostatectomy (RALRP). However, these procedures can lead to hemodynamic changes. This study aimed to investigate the effects of these interventions on the perfusion index (PI) and the Pleth variability index (PVI) in patients undergoing RALRP under general anesthesia.
METHODS: Fifty-three patients scheduled for RALRP underwent standard monitoring; PI and PVI values were monitored using a finger probe. PI, PVI, hemodynamic and respiratory parameters, and intraabdominal pressure were recorded before and after anesthesia induction, after adopting the Trendelenburg position, after pneumoperitoneum, after pneumoperitoneum and the Trendelenburg position, at 15 min, 30 min, in the supine position, after carbon dioxide (CO2) desufflation, and after extubation.
Read the detailed description
Introduction Robot-assisted laparoscopic radical prostatectomy (RYLRP) is currently the most frequently performed surgical procedure using the Da Vinci Robotic System. In this procedure, the steep Trendelenburg position (30° - 45° head down) and pneumoperitoneum (insufflation of the intraabdominal space with CO2) are used to enhance surgical visibility in the retroperitoneal area. However, the patient position and pneumoperitoneum used in robotic surgery can lead to fluctuations in hemodynamic parameters resulting from physiological changes in the cardiovascular and respiratory systems. Consequently, proper hemodynamic monitoring and optimal fluid management can reduce the risk of complications and improve outcomes in patients.
Perfusion index (PI) is a hemodynamic parameter calculated by looking at the absorption of infrared light by pulse oximetry to evaluate continuous tissue perfusion for a specific time interval. In contrast, the Pleth variability index (PVI), a dynamic variable used for regulating fluid management, is computed based on changes in PI caused by ventilation over at least one respiratory cycle. Both parameters are key non-invasive methods for hemodynamic monitoring during patient follow-up as they provide accurate information about tissue perfusion. However, only a few studies have evaluated the effects of patient position and pneumoperitoneum on PI and PVI in laparoscopic surgeries. Therefore, this study aimed to prospectively investigate the effects of the steep Trendelenburg position and pneumoperitoneum on PVI and PI in patients scheduled for RYLRP under general anesthesia.
Materials and methods This prospective observational study was approved by the Ege University Faculty of Medicine Clinical Research Ethics Committee (approval number: E222840/280; dated July 7, 2021). Patients belonging to ASA classes I-II, aged between 25 and 80 years, and scheduled for elective RYLRP under general anesthesia were included in the study. Patients deemed suitable for the study were explained about the study, and written voluntary informed consent for participation was obtained. Two patients were eventually dropped from the study because of conversion to open surgery. Additionally, patients with an ASA score above III, those unsuitable for robotic surgery, and those who developed hemodynamic instability or respiratory complications during the intraoperative period were excluded.
Preanesthetic evaluations of the patients were performed at least 24 hour before the operation. Preoperative data, including age, weight, height, body mass index, ASA classification, and additional medical history, were recorded for each patient.
After being admitted to the operating room, standard monitoring (electrocardiogram, non-invasive blood pressure, peripheral oxygen saturation) was performed. In addition, non-invasive hemoglobin, PI, and PVI monitoring were conducted using a finger probe (Masimo Radikal 7, Masimo Corp., Irvine, CA, USA) which was placed on the fourth digit of the hand without the non-invasive blood pressure cuff. A 16-G or 18-G intravenous (IV) cannula was inserted, and an Isolyte-S infusion was initiated.
After 3 min of pre-oxygenation with 100% O2, standard anesthesia induction (using 0.5 mg atropine, 1 mg/kg lidocaine, 2 - 3 mg/kg propofol, 1-3 µg/kg fentanyl, and 0.6 mg/kg rocuronium bromide) was performed. Following adequate mask ventilation, the patients were intubated with an endotracheal tube with an internal diameter of 7.5 - 8.5 mm. The endotracheal tube placement was verified by confirming equal ventilation in both lungs and observing the end-tidal carbon dioxide (ETCO2) waveform in the capnograph. Patients were then placed on volume-controlled mechanical ventilation with a tidal volume of 6-8 mL/kg and ETCO2 maintained at 35 - 40 mmHg. Invasive arterial blood pressure measurements were performed via radial artery cannulation throughout the operation. Anesthesia maintenance included a mixture of 50 % O2 and air with 2 % MAC sevoflurane (Sevoflurane Liquid 250 ml®, Abbott, UK) and remifentanil infusion.
After anesthesia induction and intubation, the patients were placed in a 45° steep Trendelenburg position. Five minutes after positioning, hemodynamic and respiratory parameters were recorded, and the patients were returned to the supine position. After returning to the supine position, pneumoperitoneum was established with CO2, and hemodynamic and respiratory parameters were recorded again 5 min later.
Measurements were taken at the following time points: before anesthesia induction (T0), 5 min after induction (T1), 5 min after the steep Trendelenburg position was applied (T2), 5 min after establishing pneumoperitoneum (T3), 5 min (T4), 15 min (T5) and 30 min (T6) after pneumoperitoneum and the steep Trendelenburg position were applied together, upon returning to the supine position (T7), after CO2 desufflation (T8), and after extubation (T9). The following parameters were recorded: hemodynamic parameters (systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, PI, and PDI), respiratory parameters (tidal volume, respiratory rate, peak airway pressure, mean airway pressure, PEEP, ETCO2, oxygen saturation (SpO2), and compliance), intraabdominal pressure, non-invasive hemoglobin, and body temperature. At the end of the surgery, the operation time, anesthesia time, pneumoperitoneum duration, intraoperative fluid volume administered, urine output, and intraoperative bleeding amount were recorded (Figure 1).
The data so collected were analyzed using IBM SPSS (version 23.0; IBM Corp., Armonk, NY). Frequency and percentage were computed for categorical data, whereas mean, standard deviation (SD), median, and range were presented as descriptive values for continuous data. Friedman's two-way analysis of variance by rank was employed to assess the differences between dependent measurements at different time points. A p-value of 0.05 was considered statistically significant.
- Conditions
- Perfusion Index, Pleth Variability Index
- Keywords
- Perfusion index, Pleth variability index, Robotic surgery, Pneumoperitoneum, Steep trendelenburg position
- Medical subject headings
- Pneumoperitoneum
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic effects of steep trendelenburg position and pneumoperitoneum in urologic robotic surgery
Can steep trendelenburg position and pneumoperitoneum cause hemodynamic changes in urologic robotic surgery? Hemodynamic measurements were taken at specific time points during the operation. The following hemodinamic parameters, Perfusion index (PI) and Pleth variability index, were recorded.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start29 Nov 2022
- Primary completion14 Apr 2023
- Study completion14 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perfusion IndexStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nursen Karaca, Ege University
- Investigators
- Işık Alper, Study director, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351241
- Sponsor's protocol ID
- E.222840/280
- Status last verified
- Apr 2024
- First submitted
- 18 Mar 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects of Steep Trendelenburg Position and Pneumoperitoneum in Urologic Robotic Surgery: a Prospective Study
- ClinicalTrials.gov ID
- NCT06351241
- Acronym / sponsor ID
- E.222840/280
- Conditions
- Perfusion Index, Pleth Variability Index
- Keywords
- Perfusion index, Pleth variability index, Robotic surgery, Pneumoperitoneum, Steep trendelenburg position
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 14 Apr 2023 (actual)
- Study completion
- 14 Apr 2023 (actual)
- First posted
- 8 Apr 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.
BACKGROUND: The steep Trendelenburg position and pneumoperitoneum are used to improve surgical visibility in robot-assisted laparoscopic radical prostatectomy (RALRP). However, these procedures can lead to hemodynamic changes. This study aimed to investigate the effects of these interventions on the perfusion index (PI) and the Pleth variability index (PVI) in patients undergoing RALRP under general anesthesia.
METHODS: Fifty-three patients scheduled for RALRP underwent standard monitoring; PI and PVI values were monitored using a finger probe. PI, PVI, hemodynamic and respiratory parameters, and intraabdominal pressure were recorded before and after anesthesia induction, after adopting the Trendelenburg position, after pneumoperitoneum, after pneumoperitoneum and the Trendelenburg position, at 15 min, 30 min, in the supine position, after carbon dioxide (CO2) desufflation, and after extubation.
Detailed description
Introduction Robot-assisted laparoscopic radical prostatectomy (RYLRP) is currently the most frequently performed surgical procedure using the Da Vinci Robotic System. In this procedure, the steep Trendelenburg position (30° - 45° head down) and pneumoperitoneum (insufflation of the intraabdominal space with CO2) are used to enhance surgical visibility in the retroperitoneal area. However, the patient position and pneumoperitoneum used in robotic surgery can lead to fluctuations in hemodynamic parameters resulting from physiological changes in the cardiovascular and respiratory systems. Consequently, proper hemodynamic monitoring and optimal fluid management can reduce the risk of complications and improve outcomes in patients.
Perfusion index (PI) is a hemodynamic parameter calculated by looking at the absorption of infrared light by pulse oximetry to evaluate continuous tissue perfusion for a specific time interval. In contrast, the Pleth variability index (PVI), a dynamic variable used for regulating fluid management, is computed based on changes in PI caused by ventilation over at least one respiratory cycle. Both parameters are key non-invasive methods for hemodynamic monitoring during patient follow-up as they provide accurate information about tissue perfusion. However, only a few studies have evaluated the effects of patient position and pneumoperitoneum on PI and PVI in laparoscopic surgeries. Therefore, this study aimed to prospectively investigate the effects of the steep Trendelenburg position and pneumoperitoneum on PVI and PI in patients scheduled for RYLRP under general anesthesia.
Materials and methods This prospective observational study was approved by the Ege University Faculty of Medicine Clinical Research Ethics Committee (approval number: E222840/280; dated July 7, 2021). Patients belonging to ASA classes I-II, aged between 25 and 80 years, and scheduled for elective RYLRP under general anesthesia were included in the study. Patients deemed suitable for the study were explained about the study, and written voluntary informed consent for participation was obtained. Two patients were eventually dropped from the study because of conversion to open surgery. Additionally, patients with an ASA score above III, those unsuitable for robotic surgery, and those who developed hemodynamic instability or respiratory complications during the intraoperative period were excluded.
Preanesthetic evaluations of the patients were performed at least 24 hour before the operation. Preoperative data, including age, weight, height, body mass index, ASA classification, and additional medical history, were recorded for each patient.
After being admitted to the operating room, standard monitoring (electrocardiogram, non-invasive blood pressure, peripheral oxygen saturation) was performed. In addition, non-invasive hemoglobin, PI, and PVI monitoring were conducted using a finger probe (Masimo Radikal 7, Masimo Corp., Irvine, CA, USA) which was placed on the fourth digit of the hand without the non-invasive blood pressure cuff. A 16-G or 18-G intravenous (IV) cannula was inserted, and an Isolyte-S infusion was initiated.
After 3 min of pre-oxygenation with 100% O2, standard anesthesia induction (using 0.5 mg atropine, 1 mg/kg lidocaine, 2 - 3 mg/kg propofol, 1-3 µg/kg fentanyl, and 0.6 mg/kg rocuronium bromide) was performed. Following adequate mask ventilation, the patients were intubated with an endotracheal tube with an internal diameter of 7.5 - 8.5 mm. The endotracheal tube placement was verified by confirming equal ventilation in both lungs and observing the end-tidal carbon dioxide (ETCO2) waveform in the capnograph. Patients were then placed on volume-controlled mechanical ventilation with a tidal volume of 6-8 mL/kg and ETCO2 maintained at 35 - 40 mmHg. Invasive arterial blood pressure measurements were performed via radial artery cannulation throughout the operation. Anesthesia maintenance included a mixture of 50 % O2 and air with 2 % MAC sevoflurane (Sevoflurane Liquid 250 ml®, Abbott, UK) and remifentanil infusion.
After anesthesia induction and intubation, the patients were placed in a 45° steep Trendelenburg position. Five minutes after positioning, hemodynamic and respiratory parameters were recorded, and the patients were returned to the supine position. After returning to the supine position, pneumoperitoneum was established with CO2, and hemodynamic and respiratory parameters were recorded again 5 min later.
Measurements were taken at the following time points: before anesthesia induction (T0), 5 min after induction (T1), 5 min after the steep Trendelenburg position was applied (T2), 5 min after establishing pneumoperitoneum (T3), 5 min (T4), 15 min (T5) and 30 min (T6) after pneumoperitoneum and the steep Trendelenburg position were applied together, upon returning to the supine position (T7), after CO2 desufflation (T8), and after extubation (T9). The following parameters were recorded: hemodynamic parameters (systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, PI, and PDI), respiratory parameters (tidal volume, respiratory rate, peak airway pressure, mean airway pressure, PEEP, ETCO2, oxygen saturation (SpO2), and compliance), intraabdominal pressure, non-invasive hemoglobin, and body temperature. At the end of the surgery, the operation time, anesthesia time, pneumoperitoneum duration, intraoperative fluid volume administered, urine output, and intraoperative bleeding amount were recorded (Figure 1).
The data so collected were analyzed using IBM SPSS (version 23.0; IBM Corp., Armonk, NY). Frequency and percentage were computed for categorical data, whereas mean, standard deviation (SD), median, and range were presented as descriptive values for continuous data. Friedman's two-way analysis of variance by rank was employed to assess the differences between dependent measurements at different time points. A p-value of 0.05 was considered statistically significant.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 25 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients belonging to ASA classes I-II, aged between 25 and 80 years, and scheduled for elective robot-assisted laparoscopic radical prostatectomy under general anesthesia were included in the study. Patients deemed suitable for the study were explained about the study, and written voluntary informed consent for participation was obtained.
Key inclusion criteria (3 listed)
- Patients belonging to ASA classes I-II
- Aged between 25 and 80 years
- Elective robot-assisted laparoscopic radical prostatectomy under general anesthesia
Key exclusion criteria (4 listed)
- conversion to open surgery
- patients with an ASA score above III
- unsuitable for robotic surgery
- who developed hemodynamic instability or respiratory complications during the intraoperative period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hemodynamic effects of steep trendelenburg position and pneumoperitoneum in urologic robotic surgery
Time frame: 1 year
Can steep trendelenburg position and pneumoperitoneum cause hemodynamic changes in urologic robotic surgery? Hemodynamic measurements were taken at specific time points during the operation. The following hemodinamic parameters, Perfusion index (PI) and Pleth variability index, were recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
Related trials for Perfusion Index
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
Recruiting
Perfusion Index for Postoperative Pain Assessment in Pediatric Adenotonsillectomy
Postoperative Pain, Adenotonsillectomy
Not yet recruiting
Perfusion Index in Monitoring Recovery From Brachial Plexus Block After Forearm Surgery
Forearm Surgeries, Brachial Plexus Blockade
RecruitingObservational study
The Role of Preoperative Internal Jugular Vein Collapsibility and Perfusion Index in Predicting Hypotension After Spinal Anesthesia in Elective Cesarean Sections: A Prospective Observational Study
Postspinal Hypotension, Cesarean Birth
Not yet recruitingObservational study
Continuous Assessment of Brain Blood Perfusion in Subarachnoid Hemorrhage Patients Using Near-Infrared Spectroscopy (NIRS)
Subarachnoid Hemorrhage, Aneurysmal
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. This study is not recruiting at the moment.
Işık Alper study director
Ege University
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 Perfusion Index and Pleth Variability Index, run by Ege University at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 8 Apr 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamic effects of steep trendelenburg position and pneumoperitoneum in urologic robotic surgery (time frame: 1 year). 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 8 Apr 2024.