Intraoperative Driving Pressure and Postoperative Lung Ultrasound Score in Robot-Assisted Radical Prostatectomy
9 de junio de 2026 actualizado por: Fehmi Güralp Güray, Ankara Etlik City Hospital
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.
Descripción general del estudio
Estado
Reclutamiento
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Estimado)
76
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Fehmi Güralp Güray, MD
- Número de teléfono: +905058618969
- Correo electrónico: guralpguray1995@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Savas Altınsoy, MD, Prof.
- Número de teléfono: +905332257104
- Correo electrónico: savasaltinsoy@gmail.com
Ubicaciones de estudio
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Ankara
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Ankara, Ankara, Turquía (Türkiye), 06170
- Reclutamiento
- Etlik City Hospital
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Contacto:
- Fehmi G Güray
- Número de teléfono: 05058618969
- Correo electrónico: guralpguray1995@gmail.com
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
Adult male patients scheduled for elective robot-assisted laparoscopic radical prostatectomy at Etlik City Hospital.
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Lung Ultrasound Score (LUS) From Preoperative Baseline to 24 Hours Postoperatively
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Lung Ultrasound Score (LUS) From Preoperative Baseline(LUS0) to 30 Minutes Postoperatively(LUS1)
Periodo de tiempo: Baseline (T0: pre-induction) and 30 minutes postoperatively (LUS 1).
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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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
30 de mayo de 2026
Finalización primaria (Estimado)
20 de agosto de 2026
Finalización del estudio (Estimado)
15 de septiembre de 2026
Fechas de registro del estudio
Enviado por primera vez
5 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
20 de mayo de 2026
Publicado por primera vez (Actual)
28 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- AEŞH-EK-2026-018
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .