Prostate CancerNCT05669443
Effect of Optimized PEEP on Mechanical Ventilation During Robot Assisted Laparoscopic Prostatectomy
A study testing conventional PEEP and optimized PEEP in people with Prostate Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
Steep trendelenburg posture or pneumoperitoneum for surgery causes ventilation problems during surgery, so finding a way to overcome is a challenging task for anesthesiologists. In this study, for patients undergoing robot assisted laparoscopic prostatectomy under general anesthesia, anesthesia is going to perform by… Read more about this study
- Who is it for?
- Ages 20 to 70 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- conventional PEEP and optimized PEEP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Apr 2023to 10 Nov 2024
- Phase
- Interventional
- 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 20 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 - 70 years of age who are scheduled for robotic assisted laparoscopic prostatectomy at the Department of Urology, Gangnam Severance Hospital,
- ASA-PS (American Society of Anesthesiology Body Rating) I-IlI,
- Patients with a BMI of 35 kg/m2 or less
Who cannot join
- Patients with lung disease
- BMI >35kg/m2
- Patients for whom positive end-tidal pressure cannot be applied (large bullae, severe cardiac disease)
- patient refusal
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gangnam Severacne Hospital Yonsei University College of Medicine
Seoul
Jiwon Lee, 82-2-2019-4601, BELIEF705@yuhs.ac
About this study
Official title: Application of Individualized Positive End-expiratory Pressure Using Electrical Impedance Tomography (EIT) in Patients Undergoing Robot Assisted Laparoscopic Prostatectomy : a Randomized Controlled Study
Steep trendelenburg posture or pneumoperitoneum for surgery causes ventilation problems during surgery, so finding a way to overcome is a challenging task for anesthesiologists. In this study, for patients undergoing robot assisted laparoscopic prostatectomy under general anesthesia, anesthesia is going to perform by applying conventional positive end-expiratory pressure (PEEP 5cmH2O) or individually determined positive end-expiratory pressure values for each patient using electrical impedance tomography. We plan to compare intraoperative ventilation through arterial blood gas analysis to find out the way to improve intraoperative ventilation.
- Conditions
- Prostate Cancer
- Being tested
- conventional PEEP, optimized PEEP
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional PEEPDevice
Maintain positive end expiratory pressure at 5 cmH2O throughout the surgery.
optimized PEEPDevice
Immediately after induction of anesthesia, the patient remains unapplied to PEEP. After pneumoperitoneum + Trendelenburg posture, an appropriate PEEP value is derived using electrical impedance tomography (airtom®). And then derived value ( = optimized PEEP value) is applied until the end of the operation.
| Study group | Role | What they receive |
|---|---|---|
| conventional PEEP | Experimental | Apply of PEEP 5 Receives: Device: conventional PEEP |
| optimized PEEP | Active comparator | Apply of optimized PEEP derived using EIT (airtom®) Receives: Device: optimized PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2/FiO2
PaO2/FiO2 is the ratio of arterial oxygen partial pressure (PaO2) to oxygen fraction (FiO2), and is a commonly used indicator for evaluating pulmonary ventilation and diagnosing lung damage. Using this index, it is possible to determine whether oxygen obtained through the lungs is well delivered to the blood or not. It can be easily obtained by arterial blood gas analysis without complicated formulas or graphs.
Measured: end of surgery (before extubation)
Secondary outcomes (6)
PaO2/FiO2
partial pressure (PaO2) to oxygen fraction (FiO2), and is a commonly used indicator for evaluating pulmonary ventilation and diagnosing lung damage. Using this index, it is possible to determine whether oxygen obtained through the lungs is well delivered to the blood or not. It can be easily obtained by arterial blood gas analysis without complicated formulas or graphs.
Measured: 15 minutes after intubation, 1 hour after pnemoperitoneum
ROI (region of interests)
region of interest using EIT
Measured: 15 minutes after intubation, 1 hour after pnemoperitoneum, end of surgery (before extubation)
inhomogeneity index
inhomogeneity index : this index calculated from tidal EIT images representing the difference in impedance between the end of inspiration and the end of expiration.
Measured: 15 minutes after intubation, 1 hour after pnemoperitoneum, end of surgery (before extubation)
total amount of fluid administered during surgery
Measured: end or surgery
total dose of vasopressor administered during surgery
Measured: end of surgery
length of hospitalization after surgery
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start3 Apr 2023
- Primary completion10 Nov 2024 (estimated)
- Study completion10 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chul Ho Chang, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669443
- Sponsor's protocol ID
- 3-2022-0361
- Status last verified
- Apr 2024
- First submitted
- 9 Dec 2022
- 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
- Application of Individualized Positive End-expiratory Pressure Using Electrical Impedance Tomography (EIT) in Patients Undergoing Robot Assisted Laparoscopic Prostatectomy : a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05669443
- Acronym / sponsor ID
- 3-2022-0361
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 10 Nov 2024 (estimated)
- Study completion
- 10 Nov 2024 (estimated)
- First posted
- 30 Dec 2022 (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.
Steep trendelenburg posture or pneumoperitoneum for surgery causes ventilation problems during surgery, so finding a way to overcome is a challenging task for anesthesiologists. In this study, for patients undergoing robot assisted laparoscopic prostatectomy under general anesthesia, anesthesia is going to perform by applying conventional positive end-expiratory pressure (PEEP 5cmH2O) or individually determined positive end-expiratory pressure values for each patient using electrical impedance tomography. We plan to compare intraoperative ventilation through arterial blood gas analysis to find out the way to improve intraoperative ventilation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional PEEP | Experimental | Device: conventional PEEPApply of PEEP 5 |
| optimized PEEP | Active comparator | Device: optimized PEEPApply of optimized PEEP derived using EIT (airtom®) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 20 - 70 years of age who are scheduled for robotic assisted laparoscopic prostatectomy at the Department of Urology, Gangnam Severance Hospital,
- ASA-PS (American Society of Anesthesiology Body Rating) I-IlI,
- Patients with a BMI of 35 kg/m2 or less
Key exclusion criteria (4 listed)
- Patients with lung disease
- BMI >35kg/m2
- Patients for whom positive end-tidal pressure cannot be applied (large bullae, severe cardiac disease)
- patient refusal
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 |
|---|---|---|
| conventional PEEPMaintain positive end expiratory pressure at 5 cmH2O throughout the surgery. | Device | conventional PEEP |
| optimized PEEPImmediately after induction of anesthesia, the patient remains unapplied to PEEP. After pneumoperitoneum + Trendelenburg posture, an appropriate PEEP value is derived using electrical impedance tomography (airtom®). And then derived value ( = optimized PEEP value) is applied until the end of the operation. | Device | optimized PEEP |
Primary outcome
PaO2/FiO2
Time frame: end of surgery (before extubation)
PaO2/FiO2 is the ratio of arterial oxygen partial pressure (PaO2) to oxygen fraction (FiO2), and is a commonly used indicator for evaluating pulmonary ventilation and diagnosing lung damage. Using this index, it is possible to determine whether oxygen obtained through the lungs is well delivered to the blood or not. It can be easily obtained by arterial blood gas analysis without complicated formulas or graphs.
6 secondary outcomes
PaO2/FiO2
Time frame: 15 minutes after intubation, 1 hour after pnemoperitoneum
ROI (region of interests)
Time frame: 15 minutes after intubation, 1 hour after pnemoperitoneum, end of surgery (before extubation)
inhomogeneity index
Time frame: 15 minutes after intubation, 1 hour after pnemoperitoneum, end of surgery (before extubation)
total amount of fluid administered during surgery
Time frame: end or surgery
total dose of vasopressor administered during surgery
Time frame: end of surgery
length of hospitalization after surgery
Time frame: 1 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional PEEP and optimized PEEP in people with Prostate Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.
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: status not confirmed, 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chul-Ho Chang (82-2-2019-4601, ANEZZANG@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PaO2/FiO2 (time frame: end of surgery (before extubation)). 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.