Respiratory MechanicsNCT07667907
vNOTES vs Laparoscopy: Respiratory Mechanics and Hemodynamics
An observational study of Respiratory Mechanics and Hemodynamics, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Pneumoperitoneum and Trendelenburg position are unavoidable in laparoscopic surgery and are known to have adverse effects on intraoperative respiratory mechanics and hemodynamics. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Respiratory Mechanics, Hemodynamics
- What is being tested?
- vNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery and Laparoscopic Gynecological Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2026to 1 Jul 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult female patients aged 18-75 years scheduled for elective gynecological surgery under general anesthesia.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, Yıldırım, 16350
Selvinaz YÜKSEL TANRIVERDİ, MD, +90(258)2966000, yukselselvinaz@gmail.com
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Respiratory Mechanics, Hemodynamics
- Being tested
- vNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery, Laparoscopic Gynecological Surgery
- Keywords
- vNOTES, Laparoscopy, Respiratory Mechanics, Hemodynamics, Pneumoperitoneum, Trendelenburg
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vNOTES (Vaginal Natural Orifice Transluminal Endoscopic SurgeryProcedure or surgery
Also called Vaginal NOTES, Natural Orifice Transluminal Endoscopic Surgery
Elective gynecological surgery performed via vaginal natural orifice transluminal endoscopic surgery with lower Trendelenburg angle and insufflation pressure compared to conventional laparoscopy.
Laparoscopic Gynecological SurgeryProcedure or surgery
Also called Laparoscopy
Conventional laparoscopic gynecological surgery performed with standard pneumoperitoneum and Trendelenburg positioning.
| Study group | Role | What they receive |
|---|---|---|
| vNOTES Group | Patients undergoing elective gynecological surgery via Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES). Receives: Procedure: vNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery | |
| Laparoscopic Surgery Group | Patients undergoing elective gynecological surgery via conventional laparoscopic surgery. Receives: Procedure: Laparoscopic Gynecological Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Driving Pressure (DP)
Driving pressure measured at four intraoperative time points to compare the effects of vNOTES and laparoscopic gynecological surgery on respiratory mechanics.
Measured: 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)
Peak Airway Pressure (Ppeak)
Peak airway pressure measured at four intraoperative time points to compare the effects of vNOTES and laparoscopic gynecological surgery on respiratory mechanics.
Measured: 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)
Plateau Pressure (Pplateau)
Plateau pressure measured at four intraoperative time points to compare the effects of vNOTES and laparoscopic gynecological surgery on respiratory mechanics.
Measured: 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)
Respiratory System Compliance (Crs)
Respiratory system compliance measured at four intraoperative time points to compare the effects of vNOTES and laparoscopic gynecological surgery on respiratory mechanics.
Measured: 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)
Mean Arterial Pressure (MAP)
Mean arterial pressure measured at four intraoperative time points to compare the hemodynamic effects of vNOTES and laparoscopic gynecological surgery.
Measured: 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)
Heart Rate (HR)
Heart rate measured at four intraoperative time points to compare the hemodynamic effects of vNOTES and laparoscopic gynecological surgery.
Measured: 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)
Secondary outcomes (3)
Mechanical Power (MPtot and MPdyn)
Total and dynamic mechanical power calculated at four intraoperative time points to assess ventilator-induced lung injury risk in vNOTES and laparoscopic gynecological surgery.
Measured: 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)
Vasopressor Requirement
Incidence of vasopressor use and total vasopressor dose administered intraoperatively in vNOTES and laparoscopic gynecological surgery groups.
Measured: ntraoperative (from surgical start to end of surgery)
Intraoperative Opioid Consumption
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.
Measured: Intraoperative (from surgical start to end of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Respiratory MechanicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Selvinaz Yüksel Tanrıverdi, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667907
- Sponsor's protocol ID
- BursaYIERHTanriverdi-001
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient confidentiality concerns.
Publications
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.
PubMed 40642630Neto 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.
PubMed 26947624Sarikaya 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.
PubMed 40313045