- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07610824
Intraoperative Driving Pressure and Postoperative Lung Ultrasound Score in Robot-Assisted Radical Prostatectomy
Evaluation of the Relationship Between Intraoperative Driving Pressure and Postoperative Lung Ultrasound Score in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy
Studieoversikt
Status
Detaljert beskrivelse
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Fehmi Güralp Güray, MD
- Telefonnummer: +905058618969
- E-post: guralpguray1995@gmail.com
Studer Kontakt Backup
- Navn: Savas Altınsoy, MD, Prof.
- Telefonnummer: +905332257104
- E-post: savasaltinsoy@gmail.com
Studiesteder
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Ankara
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Ankara, Ankara, Tyrkia (Türkiye), 06170
- Rekruttering
- Etlik City Hospital
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Ta kontakt med:
- Fehmi G Güray
- Telefonnummer: 05058618969
- E-post: guralpguray1995@gmail.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Lung Ultrasound Score (LUS) From Preoperative Baseline to 24 Hours Postoperatively
Tidsramme: Baseline LUS0 (T0: pre-induction) and 24 hours postoperatively (LUS 2).
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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).
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Baseline LUS0 (T0: pre-induction) and 24 hours postoperatively (LUS 2).
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Lung Ultrasound Score (LUS) From Preoperative Baseline(LUS0) to 30 Minutes Postoperatively(LUS1)
Tidsramme: Baseline (T0: pre-induction) and 30 minutes postoperatively (LUS 1).
|
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).
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Baseline (T0: pre-induction) and 30 minutes postoperatively (LUS 1).
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Correlation Between Total Anesthesia Duration and Postoperative Changes in Lung Ultrasound Scores (LUS)
Tidsramme: 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).
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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).
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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).
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Correlation of Intraoperative Mechanical Power With Changes in Lung Ultrasound Scores (LUS)
Tidsramme: 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.
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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.
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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.
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Correlation Between Intraoperative Driving Pressure and Arterial Blood Gas Parameters
Tidsramme: 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).
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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).
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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).
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Incidence of Postoperative Pulmonary Complications (PPCs) and Correlation With Intraoperative Driving Pressure
Tidsramme: From the end of surgery (extubation) up to 24 hours postoperatively.
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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.
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From the end of surgery (extubation) up to 24 hours postoperatively.
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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- Li 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.
- Zhang 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- AEŞH-EK-2026-018
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