- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상태
상세 설명
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Fehmi Güralp Güray, MD
- 전화번호: +905058618969
- 이메일: guralpguray1995@gmail.com
연구 연락처 백업
- 이름: Savas Altınsoy, MD, Prof.
- 전화번호: +905332257104
- 이메일: savasaltinsoy@gmail.com
연구 장소
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Ankara
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Ankara, Ankara, 터키 (Türkiye), 06170
- 모병
- Etlik City Hospital
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연락하다:
- Fehmi G Güray
- 전화번호: 05058618969
- 이메일: guralpguray1995@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
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디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Lung Ultrasound Score (LUS) From Preoperative Baseline to 24 Hours Postoperatively
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Lung Ultrasound Score (LUS) From Preoperative Baseline(LUS0) to 30 Minutes Postoperatively(LUS1)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- AEŞH-EK-2026-018
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