Lung CollapseNCT06909630
Individualized PEEP and Driving Pressure Ventilation on Postoperative Lung Complications in Robot Prostatectomy Surgery
A study testing Driving pressure group in people with Lung Collapse, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
In the case of robotic prostate cancer surgery under general anesthesia, the surgical posture is extreme Trendelenburg. Therefore, airway pressure is very high during mechanical ventilation, and there is a possibility of postoperative pulmonary complications. Read more about this study
- Who is it for?
- Ages 19 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Lung Collapse
- What is being tested?
- Driving pressure group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Jan 2023to 14 Jun 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 19 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- elective RALP surgery under genenal anesthesia
- ASA 1-2
- 19 years of age or older
- Consented to participate in the study
Who cannot join
- Do not consent to participate in the study
- ≥ BMI 40 kg/m2
- Moderate or severe obstructive/restrictive pulmonary disease on pulmonary function tests
- Preoperative serious cardiovascular disease
- Required postoperative ventilator care at ICU care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Individualized PEEP Using Driving Pressure Ventilation on Postoperative Lung Complications in Robot Prostatectomy Surgery: Prospective Randomized Clinical Trial
In the case of robotic prostate cancer surgery under general anesthesia, the surgical posture is extreme Trendelenburg. Therefore, airway pressure is very high during mechanical ventilation, and there is a possibility of postoperative pulmonary complications. In order to prevent postoperative pulmonary complications, we tried to apply end-tidal pressure suitable for each individual to set the most tidal volume that can reduce the burden on the lungs during the perioperative period.
Read the detailed description
This study is conducted on patients who are scheduled for prostate surgery under general anesthesia with robot assistance. Subjects who consented to the consent form the day before the surgery were conducted with people aged 19 years or older who belonged to the American Society of Anesthesiologists (ASA) class I or II. In the drive group, the ventilator setting is fixed at tidal volume 6-8ml/kg and respiratory rate 15 breathes/min, and then the recruitment maneuver (RM, alveolar recruitment) is performed within the range that does not cause hemodynamic instability. After that, the PEEP is gradually raised from 5 cmH2O to 20 cmH2O. Driving pressure finds the lowest value. If there is no significant change even when the pressure change raises the PEEP, select the lowest PEEP. In the control group, PEEP is maintained in 5 cmH2O until the end of surgery. The primary outcome of the study is to confirm the presence or absence of postoperative pulmonary complications using Chest X-rays, vital signs, and blood tests. It is the individualized PEEP value as a secondary outcome. The related driving pressure and compliance will also be observed. In addition, anesthesia/surgical time, use of vasopressors, amount of blood loss, amount of fluid, and amount of urine will be measured.
- Conditions
- Lung Collapse
- Being tested
- Driving pressure group
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Driving pressure groupOther
individual PEEP
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | PEEP is maintained in 5 cmH2O until the end of surgery. |
| Driving pressure group | Experimental | Individual PEEP is applied according to the driving pressure. Receives: Other: Driving pressure group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pulmonary complication(PPC)
Post operative lung complication
Measured: up to PostOperative Day(POD) #3
Secondary outcomes (2)
Individual ventilatory setting
PEEP in cmH2O at mechanical ventilation setting static lung compliance in liters/cmH2O at measured mechanical ventilation and calculated driving pressure in cmH20 Driving pressure (DP or ΔP) is defined as the distending pressure above the applied positive end-expiratory pressure (PEEP) required to generate tidal volume (VT)
- C stat= tidal volume/ Driving pressure
- Driving pressure= tidal volume/C stat
Measured: during opertaion
blood pressure(hypotension)
Types and dosages of vasopressor agents used when the mean blood pressure is ≤ 60 mmHg.
** vasopressor agents: Ephedrine, phenylepherine, Norepinepherine
- Ephedrine single intravenous injection: 5mg
- phenylepherine single intravenous injection: 20mcg continueous infusion: mcg/kg/min at 100mcg/cc
- Norepinepherine continueous infusion: mcg/kg/min at 10mcg/cc
Measured: during opertaion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start6 Jan 2023
- Primary completion12 Jun 2024
- Study completion14 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CollapseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the drive group, the ventilator setting is fixed at tidal volume 6-8ml/kg and respiratory rate 15 breathes/min, and then the recruitment maneuver (RM, alveolar recruitment) is performed within the range that does not cause hemodynamic instability. After that, the PEEP is gradually raised from 5 cmH2O to 20 cmH2O. Driving pressure finds the lowest value. If there is no significant change even when the pressure change raises the PEEP, select the lowest PEEP. In the control group, PEEP is maintained in 5 cmH2O until the end of surgery.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu kyung Bae, Principal investigator, SNUBH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909630
- Sponsor's protocol ID
- B-2202-737-002
- Status last verified
- Jun 2024
- First submitted
- 11 Jan 2023
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Individualized PEEP Using Driving Pressure Ventilation on Postoperative Lung Complications in Robot Prostatectomy Surgery: Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06909630
- Acronym / sponsor ID
- B-2202-737-002
- Conditions
- Lung Collapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- 14 Jun 2024 (actual)
- First posted
- 3 Apr 2025 (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.
In the case of robotic prostate cancer surgery under general anesthesia, the surgical posture is extreme Trendelenburg. Therefore, airway pressure is very high during mechanical ventilation, and there is a possibility of postoperative pulmonary complications. In order to prevent postoperative pulmonary complications, we tried to apply end-tidal pressure suitable for each individual to set the most tidal volume that can reduce the burden on the lungs during the perioperative period.
Detailed description
This study is conducted on patients who are scheduled for prostate surgery under general anesthesia with robot assistance. Subjects who consented to the consent form the day before the surgery were conducted with people aged 19 years or older who belonged to the American Society of Anesthesiologists (ASA) class I or II. In the drive group, the ventilator setting is fixed at tidal volume 6-8ml/kg and respiratory rate 15 breathes/min, and then the recruitment maneuver (RM, alveolar recruitment) is performed within the range that does not cause hemodynamic instability. After that, the PEEP is gradually raised from 5 cmH2O to 20 cmH2O. Driving pressure finds the lowest value. If there is no significant change even when the pressure change raises the PEEP, select the lowest PEEP. In the control group, PEEP is maintained in 5 cmH2O until the end of surgery. The primary outcome of the study is to confirm the presence or absence of postoperative pulmonary complications using Chest X-rays, vital signs, and blood tests. It is the individualized PEEP value as a secondary outcome. The related driving pressure and compliance will also be observed. In addition, anesthesia/surgical time, use of vasopressors, amount of blood loss, amount of fluid, and amount of urine will be measured.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- In the drive group, the ventilator setting is fixed at tidal volume 6-8ml/kg and respiratory rate 15 breathes/min, and then the recruitment maneuver (RM, alveolar recruitment) is performed within the range that does not cause hemodynamic instability. After that, the PEEP is gradually raised from 5 cmH2O to 20 cmH2O. Driving pressure finds the lowest value. If there is no significant change even when the pressure change raises the PEEP, select the lowest PEEP. In the control group, PEEP is maintained in 5 cmH2O until the end of surgery.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –PEEP is maintained in 5 cmH2O until the end of surgery. |
| Driving pressure group | Experimental | Other: Driving pressure groupIndividual PEEP is applied according to the driving pressure. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- elective RALP surgery under genenal anesthesia
- ASA 1-2
- 19 years of age or older
- Consented to participate in the study
Key exclusion criteria (5 listed)
- Do not consent to participate in the study
- ≥ BMI 40 kg/m2
- Moderate or severe obstructive/restrictive pulmonary disease on pulmonary function tests
- Preoperative serious cardiovascular disease
- Required postoperative ventilator care at ICU care
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 |
|---|---|---|
| Driving pressure groupindividual PEEP | Other | Driving pressure group |
Primary outcome
Post operative pulmonary complication(PPC)
Time frame: up to PostOperative Day(POD) #3
Post operative lung complication
2 secondary outcomes
Individual ventilatory setting
Time frame: during opertaion
blood pressure(hypotension)
Time frame: during opertaion
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 3 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Yu kyung Bae principal investigator
SNUBH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Driving pressure group in people with Lung Collapse, run by Seoul National University 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 4 inclusion and 5 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 3 Apr 2025. 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?
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?
Post operative pulmonary complication(PPC) (time frame: up to PostOperative Day(POD) #3). 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 3 Apr 2025.