vNOTES vs Laparoscopy: Respiratory Mechanics and Hemodynamics
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-75
SponsorBursa Yuksek Ihtisas Training and Research Hospital
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- vNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery
- Laparoscopic Gynecological Surgery
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov