vNOTES vs Laparoscopy: Respiratory Mechanics and Hemodynamics
Comparison of the Effects of vNOTES and Laparoscopic Gynecological Surgery on Intraoperative Respiratory Mechanics and Hemodynamics: A Prospective Observational Cohort Study
Pneumoperitoneum and Trendelenburg position are unavoidable in laparoscopic surgery and are known to have adverse effects on intraoperative respiratory mechanics and hemodynamics. These conditions increase the risk of ventilator-induced lung injury (VILI) and highlight the importance of lung-protective ventilation strategies.
vNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery) is a minimally invasive technique that requires less Trendelenburg tilt and lower insufflation pressures compared to conventional laparoscopic surgery, and may therefore offer a more favorable intraoperative profile.
This prospective, observational, single-center, parallel-group cohort study aims to compare respiratory mechanics parameters (Ppeak, Pplateau, DP, MPtot, MPdyn, Crs) and hemodynamic parameters (MAP, HR, vasopressor requirement) between vNOTES (n=15) and laparoscopic gynecological surgery (n=15) groups at four intraoperative time points.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
This study aims to compare vNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery) and laparoscopic gynecological surgery in terms of intraoperative respiratory mechanics and hemodynamics in patients scheduled for elective gynecological surgery.
The findings of this study will contribute to more effective planning of ventilation and hemodynamic management by anesthesiologists in vNOTES cases, the development of lung-protective ventilation protocols, and the improvement of perioperative anesthesia quality.
This study is designed as a prospective, observational, single-center, parallel-group cohort study. Patients scheduled for elective gynecological surgery will be divided into two groups according to the surgical technique: Group 1 (vNOTES, n=15) and Group 2 (Laparoscopic surgery, n=15). No randomization will be performed; the surgical technique, insufflation pressure, and Trendelenburg angle will be left to the clinician's discretion.
Measurements will be performed at four time points: T0 (10th minute after intubation, before insufflation), T1 (15th minute after pneumoperitoneum and Trendelenburg positioning), T2 (45th minute after pneumoperitoneum; or the last 5 minutes before desufflation in cases where the 45th minute is not reached), and T3 (15th minute after desufflation). At each time point, respiratory mechanics parameters (Ppeak, Pplateau, DP, MPtot, MPdyn, Crs), hemodynamic parameters (MAP, HR, vasopressor requirement), and intraoperative opioid consumption will be recorded. Insufflation pressure, Trendelenburg angle, and surgical duration will be recorded as confounding variables.
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Selvinaz Yüksel Tanrıverdi, MD
- 전화번호: +0902242955000
- 이메일: yukselselvinaz@gmail.com
연구 장소
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Yıldırım
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Bursa, Yıldırım, 터키 (Türkiye), 16350
- Bursa Yuksek Ihtisas Training and Research Hospital
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연락하다:
- Selvinaz YÜKSEL TANRIVERDİ, MD
- 전화번호: +90(258)2966000
- 이메일: yukselselvinaz@gmail.com
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Female patients aged 18 to 75 years
- Patients scheduled for elective gynecological surgery
- Patients undergoing mechanical ventilation under general anesthesia
- ASA physical status I-III
- Patients providing written informed consent
Exclusion Criteria:
- Severe or uncontrolled chronic obstructive pulmonary disease, asthma, or other chronic pulmonary diseases
- Cardiac arrhythmia
- ASA physical status IV or above
- Patients developing intraoperative hemodynamic instability
- Patients receiving spinal or epidural anesthesia
- Cases requiring conversion to laparoscopy or laparotomy
- Patients refusing to participate
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
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vNOTES Group
Patients undergoing elective gynecological surgery via Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES).
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Elective gynecological surgery performed via vaginal natural orifice transluminal endoscopic surgery with lower Trendelenburg angle and insufflation pressure compared to conventional laparoscopy.
다른 이름들:
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Laparoscopic Surgery Group
Patients undergoing elective gynecological surgery via conventional laparoscopic surgery.
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Conventional laparoscopic gynecological surgery performed with standard pneumoperitoneum and Trendelenburg positioning.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Driving Pressure (DP)
기간: Intraoperative (T0: 10th minute after intubation before insufflation; T1: 15th minute after pneumoperitoneum and Trendelenburg positioning; T2: 45th minute after pneumoperitoneum; T3: 15th minute after desufflation)
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Driving pressure measured at four intraoperative time points to compare the effects of vNOTES and laparoscopic gynecological surgery on respiratory mechanics.
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Intraoperative (T0: 10th minute after intubation before insufflation; T1: 15th minute after pneumoperitoneum and Trendelenburg positioning; T2: 45th minute after pneumoperitoneum; T3: 15th minute after desufflation)
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Peak Airway Pressure (Ppeak)
기간: Intraoperative (T0: 10th minute after intubation before insufflation; T1: 15th minute after pneumoperitoneum and Trendelenburg positioning; T2: 45th minute after pneumoperitoneum; T3: 15th minute after desufflation)
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Peak airway pressure measured at four intraoperative time points to compare the effects of vNOTES and laparoscopic gynecological surgery on respiratory mechanics.
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Intraoperative (T0: 10th minute after intubation before insufflation; T1: 15th minute after pneumoperitoneum and Trendelenburg positioning; T2: 45th minute after pneumoperitoneum; T3: 15th minute after desufflation)
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Plateau Pressure (Pplateau)
기간: Intraoperative (T0: 10th minute after intubation before insufflation; T1: 15th minute after pneumoperitoneum and Trendelenburg positioning; T2: 45th minute after pneumoperitoneum; T3: 15th minute after desufflation)
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Plateau pressure measured at four intraoperative time points to compare the effects of vNOTES and laparoscopic gynecological surgery on respiratory mechanics.
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Intraoperative (T0: 10th minute after intubation before insufflation; T1: 15th minute after pneumoperitoneum and Trendelenburg positioning; T2: 45th minute after pneumoperitoneum; T3: 15th minute after desufflation)
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Respiratory System Compliance (Crs)
기간: Intraoperative (T0: 10th minute after intubation before insufflation; T1: 15th minute after pneumoperitoneum and Trendelenburg positioning; T2: 45th minute after pneumoperitoneum; T3: 15th minute after desufflation)
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Respiratory system compliance measured at four intraoperative time points to compare the effects of vNOTES and laparoscopic gynecological surgery on respiratory mechanics.
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Intraoperative (T0: 10th minute after intubation before insufflation; T1: 15th minute after pneumoperitoneum and Trendelenburg positioning; T2: 45th minute after pneumoperitoneum; T3: 15th minute after desufflation)
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Mean Arterial Pressure (MAP)
기간: Intraoperative (T0: 10th minute after intubation before insufflation; T1: 15th minute after pneumoperitoneum and Trendelenburg positioning; T2: 45th minute after pneumoperitoneum; T3: 15th minute after desufflation)
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Mean arterial pressure measured at four intraoperative time points to compare the hemodynamic effects of vNOTES and laparoscopic gynecological surgery.
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Intraoperative (T0: 10th minute after intubation before insufflation; T1: 15th minute after pneumoperitoneum and Trendelenburg positioning; T2: 45th minute after pneumoperitoneum; T3: 15th minute after desufflation)
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Heart Rate (HR)
기간: Intraoperative (T0: 10th minute after intubation before insufflation; T1: 15th minute after pneumoperitoneum and Trendelenburg positioning; T2: 45th minute after pneumoperitoneum; T3: 15th minute after desufflation)
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Heart rate measured at four intraoperative time points to compare the hemodynamic effects of vNOTES and laparoscopic gynecological surgery.
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Intraoperative (T0: 10th minute after intubation before insufflation; T1: 15th minute after pneumoperitoneum and Trendelenburg positioning; T2: 45th minute after pneumoperitoneum; T3: 15th minute after desufflation)
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mechanical Power (MPtot and MPdyn)
기간: Intraoperative (T0: 10th minute after intubation before insufflation; T1: 15th minute after pneumoperitoneum and Trendelenburg positioning; T2: 45th minute after pneumoperitoneum; T3: 15th minute after desufflation)
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Total and dynamic mechanical power calculated at four intraoperative time points to assess ventilator-induced lung injury risk in vNOTES and laparoscopic gynecological surgery.
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Intraoperative (T0: 10th minute after intubation before insufflation; T1: 15th minute after pneumoperitoneum and Trendelenburg positioning; T2: 45th minute after pneumoperitoneum; T3: 15th minute after desufflation)
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Vasopressor Requirement
기간: ntraoperative (from surgical start to end of surgery)
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Incidence of vasopressor use and total vasopressor dose administered intraoperatively in vNOTES and laparoscopic gynecological surgery groups.
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ntraoperative (from surgical start to end of surgery)
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Intraoperative Opioid Consumption
기간: Intraoperative (from surgical start to end of surgery)
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Cumulative total opioid consumption (fentanyl in mcg and/or remifentanil in mcg/kg/min) administered from the start of surgery to the end of surgery in vNOTES and laparoscopic gynecological surgery groups.
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Intraoperative (from surgical start to end of surgery)
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Tontu F, Akca H, Berktas CK, Asar S, Ozcan FG. The impact of pneumoperitoneum and steep Trendelenburg positioning on novel oxygenation and saturation indices in robot-assisted laparoscopic prostatectomies: A prospective observational study. Saudi J Anaesth. 2025 Jul-Sep;19(3):271-276. doi: 10.4103/sja.sja_600_24. Epub 2025 Jun 16.
- Neto AS, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Gajic O, El-Tahan MR, Ghamdi AA, Gunay E, Jaber S, Kokulu S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Ranieri VM, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Amato MB, Costa EL, de Abreu MG, Pelosi P, Schultz MJ; PROVE Network Investigators. Association between driving pressure and development of postoperative pulmonary complications in patients undergoing mechanical ventilation for general anaesthesia: a meta-analysis of individual patient data. Lancet Respir Med. 2016 Apr;4(4):272-80. doi: 10.1016/S2213-2600(16)00057-6. Epub 2016 Mar 4.
- Sarikaya S, Taskin MI, Bozhuyuk Sahin T, Guney G, Kececioglu M, Afsar S, Guney SS. Comparison of Perioperative Outcomes Between V-NOTES and Total Laparoscopic Hysterectomy: A Retrospective Analysis. J Invest Surg. 2025 Dec;38(1):2488131. doi: 10.1080/08941939.2025.2488131. Epub 2025 May 1.
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연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
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연구 기록 업데이트
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추가 정보
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기타 연구 ID 번호
기타 연구 ID 번호
- BursaYIERHTanriverdi-001
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