Mechanical VentilationNCT07610824
Intraoperative Driving Pressure and Postoperative Lung Ultrasound Score in Robot-Assisted Radical Prostatectomy
An observational study of Mechanical Ventilation and Postoperative Pulmonary Complications (PPCs), run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The primary objective of this study is to evaluate the relationship between intraoperative driving pressure and postoperative lung ultrasound scores in patients undergoing robot-assisted laparoscopic radical prostatectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Mechanical Ventilation, Postoperative Pulmonary Complications (PPCs), Prostatic Neoplams
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2026to 1 Oct 2026
- 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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Adult male patients scheduled for elective robot-assisted laparoscopic radical prostatectomy at Etlik City Hospital.
Who may be able to join
- Male patients aged between 18 and 80 years.
- Scheduled for elective robot-assisted laparoscopic radical prostatectomy.
- American Society of Anesthesiologists (ASA) physical status I, II, or III.
- Willingness to provide written informed consent.
Who cannot join
- Patient refusal to participate.
- Severe obstructive or restrictive pulmonary disease (e.g., severe COPD, uncontrolled asthma).
- Body Mass Index (BMI) > 35 kg/m^2.
- Pre-existing severe lung pathology or active pulmonary infection.
- Hemodynamic instability or severe cardiovascular disease (e.g., severe heart failure, recent myocardial infarction).
- Requirement for postoperative mechanical ventilation.
- Emergency surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Relationship Between Intraoperative Driving Pressure and Postoperative Lung Ultrasound Score in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy
The primary objective of this study is to evaluate the relationship between intraoperative driving pressure and postoperative lung ultrasound scores in patients undergoing robot-assisted laparoscopic radical prostatectomy. During this specific surgery, factors such as pneumoperitoneum and patient positioning can significantly affect respiratory mechanics. Postoperative lung condition will be objectively assessed using the lung ultrasound score (LUS). The findings may provide valuable insights for optimizing intraoperative mechanical ventilation strategies.
Read the detailed description
The primary objective of this study is to evaluate the relationship between intraoperative driving pressure and postoperative lung ultrasound scores in patients undergoing robot-assisted laparoscopic radical prostatectomy. During this specific surgery, factors such as pneumoperitoneum and patient positioning can significantly affect respiratory mechanics. By monitoring mechanical ventilation parameters, specifically driving pressure, this study aims to investigate its potential correlation with postoperative lung aeration changes. Postoperative lung condition will be objectively assessed using the lung ultrasound score (LUS). The findings may provide valuable insights for optimizing intraoperative mechanical ventilation strategies.
- Conditions
- Mechanical Ventilation, Postoperative Pulmonary Complications (PPCs), Prostatic Neoplams, Driving Pressure, Lung Ultrasonography Score
- Keywords
- driving pressure, lung ultrasonography score, postoperative pulmonary comlications
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lung Ultrasound Score (LUS) From Preoperative Baseline to 24 Hours Postoperatively
The primary outcome is the difference in lung aeration between preoperative baseline (LUS 0, at T0: pre-induction, awake, supine) and 24 hours postoperatively (LUS 2). Lung aeration is evaluated via a 12-region ultrasound protocol; each quadrant is scored 0-3, yielding a total of 0-36 (higher scores indicate worse aeration). This change (LUS 0 to LUS 2) will be correlated with the mean intraoperative driving pressure (ΔP = Pplat - PEEP). Mean ΔP is calculated as the average of measurements obtained at predefined intraoperative milestones: T_basal (immediately post-intubation), T1 (1st hour, immediately post-establishment of pneumoperitoneum and deep Trendelenburg), T2, T3, T4, T5 (hourly intervals during pneumoperitoneum/Trendelenburg maintenance), and T_neutral (within 10 minutes post-desufflation, return to supine).
Measured: Baseline LUS0 (T0: pre-induction) and 24 hours postoperatively (LUS 2).
Secondary outcomes (5)
Change in Lung Ultrasound Score (LUS) From Preoperative Baseline(LUS0) to 30 Minutes Postoperatively(LUS1)
This outcome assesses early postoperative lung aeration changes between baseline (LUS 0, at T0: pre-induction, awake, supine) and 30 minutes postoperatively in the post-anesthesia care unit (LUS 1). Aeration is evaluated via a 12-region ultrasound protocol (each quadrant scored 0-3; total 0-36). This acute change (LUS 0 to LUS 1) will be correlated with mean intraoperative driving pressure (ΔP = Pplat - PEEP). Mean ΔP is the average of measurements at specific milestones: T_basal (immediately post-intubation), T1 (1st hour, post-establishment of pneumoperitoneum and deep Trendelenburg), T2, T3, T4, T5 (hourly maintenance), and T_neutral (within 10 minutes post-desufflation, return to supine).
Measured: Baseline (T0: pre-induction) and 30 minutes postoperatively (LUS 1).
Correlation Between Total Anesthesia Duration and Postoperative Changes in Lung Ultrasound Scores (LUS)
This outcome investigates the correlation between total anesthesia/mechanical ventilation duration (measured in minutes from T0: pre-induction to extubation) and changes in lung aeration. The clinical impact of operative time on atelectasis will be evaluated by correlating this duration with early (LUS 0 at T0 to LUS 1 at postop 30 min) and persistent (LUS 0 to LUS 2 at postop 24 hours) LUS changes. The intraoperative timeline includes predefined milestones: T_basal (post-intubation), T1 (1st hour, post-pneumoperitoneum and deep Trendelenburg), T2, T3, T4, T5 (hourly maintenance), and T_neutral (post-desufflation, return to supine).
Measured: From the start of anesthesia induction until extubation (for total duration, assessed up to 6 hours) and at specific assessment points: Baseline (T0), 30 minutes postoperatively (LUS 1), and 24 hours postoperatively (LUS 2).
Correlation of Intraoperative Mechanical Power With Changes in Lung Ultrasound Scores (LUS)
This outcome evaluates cumulative energy delivered to the respiratory system (Mechanical Power, MP) during volume-controlled ventilation. Average (MP_mean) and maximum (MP_max) MP will be retrospectively calculated via the simplified Gattinoni formula using ventilator data at milestones: T_basal (immediately post-intubation), T1 (1st hour, post-pneumoperitoneum and deep Trendelenburg), T2, T3, T4, T5 (hourly maintenance), and T_neutral (post-desufflation). These intraoperative energy metrics will be correlated with early (LUS 0 to LUS 1 at 30 min) and persistent (LUS 0 to LUS 2 at 24 hours) postoperative changes in lung aeration.
Measured: Intraoperatively from anesthesia induction to the end of surgery (for mechanical power data collection, assessed up to 6 hours) and at Baseline (T0), 30 minutes (LUS 1), and 24 hours postoperatively (LUS 2) for ultrasound scores.
Correlation Between Intraoperative Driving Pressure and Arterial Blood Gas Parameters
This outcome assesses immediate physiological impacts of driving pressure (ΔP) changes induced by pneumoperitoneum and deep Trendelenburg. Arterial blood gas (ABG) parameters, specifically pH, PaO2/FiO2 ratio (Horowitz index), PaCO2, and lactate, will be correlated with the ΔP (Pplat - PEEP) measured at exact corresponding milestones: T_basal (immediately post-intubation), T1 (1st hour, immediately post-establishment of pneumoperitoneum and deep Trendelenburg), T2, T3, T4, T5 (hourly maintenance), and T_neutral (within 10 minutes post-desufflation, return to supine).
Measured: Intraoperatively, at specific predefined milestones: T_basal, T1 (1st hour, immediately post-pneumoperitoneum/Trendelenburg), T2, T3, T4, T5, and T_neutral (assessed up to 6 hours).
Incidence of Postoperative Pulmonary Complications (PPCs) and Correlation With Intraoperative Driving Pressure
This outcome tracks postoperative pulmonary complications (PPCs) to evaluate the clinical impact of intraoperative ventilation. PPCs are defined as transient or persistent desaturation (SpO2 < 92%), clinical need for supplemental oxygen, or tachypnea in the PACU. This incidence is correlated with the mean intraoperative driving pressure (ΔP) calculated as the average across milestones: T_basal (post-intubation), T1 (1st hour, post-pneumoperitoneum and deep Trendelenburg), T2, T3, T4, T5 (hourly maintenance), and T_neutral (post-desufflation, return to supine). Clinical follow-up extends up to 24 hours.
Measured: From the end of surgery (extubation) up to 24 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start30 May 2026
- Primary completion15 Sep 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fehmi Güralp Güray, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610824
- Sponsor's protocol ID
- AEŞH-EK-2026-018
- Status last verified
- Oct 2026
- First submitted
- 5 May 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yoon HK, Kim BR, Yoon S, Jeong YH, Ku JH, Kim WH. The Effect of Ventilation with Individualized Positive End-Expiratory Pressure on Postoperative Atelectasis in Patients Undergoing Robot-Assisted Radical Prostatectomy: A Randomized Controlled Trial. J Clin Med. 2021 Feb 19;10(4):850. doi: 10.3390/jcm10040850.
PubMed 33669526Li Y, Xu W, Cui Y, Sun Y, Wang C, Wen Z, An K. Effects of driving pressure-guided ventilation by individualized positive end-expiratory pressure on oxygenation undergoing robot-assisted laparoscopic radical prostatectomy: a randomized controlled clinical trial. J Anesth. 2023 Dec;37(6):896-904. doi: 10.1007/s00540-023-03251-y. Epub 2023 Sep 14.
PubMed 37707572Zhang Y, Zhu J, Xi C, Wang G. Effect of driving pressure-guided individualized positive end-expiratory pressure (PEEP) ventilation strategy on postoperative atelectasis in patients undergoing laparoscopic surgery as assessed by ultrasonography: study protocol for a prospective randomized controlled trial. Trials. 2025 Mar 26;26(1):106. doi: 10.1186/s13063-025-08819-5.
PubMed 40140868
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Intraoperative Driving Pressure and Postoperative Lung Ultrasound Score in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT07610824
- Acronym / sponsor ID
- AEŞH-EK-2026-018
- Conditions
- Mechanical Ventilation, Postoperative Pulmonary Complications (PPCs), Prostatic Neoplams, Driving Pressure, Lung Ultrasonography Score
- Keywords
- driving pressure, lung ultrasonography score, postoperative pulmonary comlications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 30 May 2026 (actual)
- Primary completion
- 15 Sep 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 28 May 2026 (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 primary objective of this study is to evaluate the relationship between intraoperative driving pressure and postoperative lung ultrasound scores in patients undergoing robot-assisted laparoscopic radical prostatectomy. During this specific surgery, factors such as pneumoperitoneum and patient positioning can significantly affect respiratory mechanics. Postoperative lung condition will be objectively assessed using the lung ultrasound score (LUS). The findings may provide valuable insights for optimizing intraoperative mechanical ventilation strategies.
Detailed description
The primary objective of this study is to evaluate the relationship between intraoperative driving pressure and postoperative lung ultrasound scores in patients undergoing robot-assisted laparoscopic radical prostatectomy. During this specific surgery, factors such as pneumoperitoneum and patient positioning can significantly affect respiratory mechanics. By monitoring mechanical ventilation parameters, specifically driving pressure, this study aims to investigate its potential correlation with postoperative lung aeration changes. Postoperative lung condition will be objectively assessed using the lung ultrasound score (LUS). The findings may provide valuable insights for optimizing intraoperative mechanical ventilation strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male patients scheduled for elective robot-assisted laparoscopic radical prostatectomy at Etlik City Hospital.
Key inclusion criteria (4 listed)
- Male patients aged between 18 and 80 years.
- Scheduled for elective robot-assisted laparoscopic radical prostatectomy.
- American Society of Anesthesiologists (ASA) physical status I, II, or III.
- Willingness to provide written informed consent.
Key exclusion criteria (7 listed)
- Patient refusal to participate.
- Severe obstructive or restrictive pulmonary disease (e.g., severe COPD, uncontrolled asthma).
- Body Mass Index (BMI) > 35 kg/m^2.
- Pre-existing severe lung pathology or active pulmonary infection.
- Hemodynamic instability or severe cardiovascular disease (e.g., severe heart failure, recent myocardial infarction).
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
Change in Lung Ultrasound Score (LUS) From Preoperative Baseline to 24 Hours Postoperatively
Time frame: Baseline LUS0 (T0: pre-induction) and 24 hours postoperatively (LUS 2).
The primary outcome is the difference in lung aeration between preoperative baseline (LUS 0, at T0: pre-induction, awake, supine) and 24 hours postoperatively (LUS 2). Lung aeration is evaluated via a 12-region ultrasound protocol; each quadrant is scored 0-3, yielding a total of 0-36 (higher scores indicate worse aeration). This change (LUS 0 to LUS 2) will be correlated with the mean intraoperative driving pressure (ΔP = Pplat - PEEP). Mean ΔP is calculated as the average of measurements obtained at predefined intraoperative milestones: T_basal (immediately post-intubation), T1 (1st hour, immediately post-establishment of pneumoperitoneum and deep Trendelenburg), T2, T3, T4, T5 (hourly intervals during pneumoperitoneum/Trendelenburg maintenance), and T_neutral (within 10 minutes post-desufflation, return to supine).
5 secondary outcomes
Change in Lung Ultrasound Score (LUS) From Preoperative Baseline(LUS0) to 30 Minutes Postoperatively(LUS1)
Time frame: Baseline (T0: pre-induction) and 30 minutes postoperatively (LUS 1).
Correlation Between Total Anesthesia Duration and Postoperative Changes in Lung Ultrasound Scores (LUS)
Time frame: From the start of anesthesia induction until extubation (for total duration, assessed up to 6 hours) and at specific assessment points: Baseline (T0), 30 minutes postoperatively (LUS 1), and 24 hours postoperatively (LUS 2).
Correlation of Intraoperative Mechanical Power With Changes in Lung Ultrasound Scores (LUS)
Time frame: Intraoperatively from anesthesia induction to the end of surgery (for mechanical power data collection, assessed up to 6 hours) and at Baseline (T0), 30 minutes (LUS 1), and 24 hours postoperatively (LUS 2) for ultrasound scores.
Correlation Between Intraoperative Driving Pressure and Arterial Blood Gas Parameters
Time frame: Intraoperatively, at specific predefined milestones: T_basal, T1 (1st hour, immediately post-pneumoperitoneum/Trendelenburg), T2, T3, T4, T5, and T_neutral (assessed up to 6 hours).
Incidence of Postoperative Pulmonary Complications (PPCs) and Correlation With Intraoperative Driving Pressure
Time frame: From the end of surgery (extubation) up to 24 hours postoperatively.
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 9 Oct 2026.
- Results publication: PubMed 33669526Yoon HK, Kim BR, Yoon S, Jeong YH, Ku JH, Kim WH. The Effect of Ventilation with Individualized Positive End-Expiratory Pressure on Postoperative Atelectasis in Patients Undergoing Robot-Assisted Radical Prostatectomy: A Randomized Controlled Trial. J Clin Med. 2021 Feb 19;10(4):850. doi: 10.3390/jcm10040850.
- Results publication: PubMed 37707572Li Y, Xu W, Cui Y, Sun Y, Wang C, Wen Z, An K. Effects of driving pressure-guided ventilation by individualized positive end-expiratory pressure on oxygenation undergoing robot-assisted laparoscopic radical prostatectomy: a randomized controlled clinical trial. J Anesth. 2023 Dec;37(6):896-904. doi: 10.1007/s00540-023-03251-y. Epub 2023 Sep 14.
- Results publication: PubMed 40140868Zhang Y, Zhu J, Xi C, Wang G. Effect of driving pressure-guided individualized positive end-expiratory pressure (PEEP) ventilation strategy on postoperative atelectasis in patients undergoing laparoscopic surgery as assessed by ultrasonography: study protocol for a prospective randomized controlled trial. Trials. 2025 Mar 26;26(1):106. doi: 10.1186/s13063-025-08819-5.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mechanical Ventilation and Postoperative Pulmonary Complications (PPCs), run by Ankara Etlik City Hospital 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 4 inclusion and 7 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 9 Oct 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 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?
Change in Lung Ultrasound Score (LUS) From Preoperative Baseline to 24 Hours Postoperatively (time frame: Baseline LUS0 (T0: pre-induction) and 24 hours postoperatively (LUS 2).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07610824, which also lists 3 linked publications.
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 9 Oct 2026.