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NCT07667907
vNOTES vs Laparoscopy: Respiratory Mechanics and Hemodynamics
Conditions: Respiratory Mechanics, Hemodynamics
Sex: Female
Ages: 18 Years – 75 Years
Healthy volunteers: No
Enrollment: 30
Sponsor: Bursa Yuksek Ihtisas Training and Research Hospital
Location: Bursa Yuksek Ihtisas Training and Research Hospital Bursa Yıldırım
Summary
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07667907). StuddyBuddy aggregates publicly available trial information.