VnotesNCT07885111
Effects of Trendelenburg Position and Pneumoperitoneum on Mechanical Power and Respiratory Mechanics During V-NOTES Surgery
An observational study of Vnotes and Respiratory Mechanics, run by Burcu Ayvazoğlu.
Trial summary
The purpose of this observational study is to evaluate the effects of Trendelenburg positioning and pneumoperitoneum on mechanical power and respiratory mechanics in adult women undergoing vaginal natural orifice transluminal endoscopic surgery (vNOTES) for bilateral tubal ligation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vnotes, Respiratory Mechanics
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of 14 adult female patients aged 18 years or older who are scheduled to undergo elective bilateral tubal ligation using the vaginal natural orifice transluminal endoscopic surgery (vNOTES) technique at Yahyali State Hospital, Kayseri, Türkiye. Eligible participants will have an American Society of Anesthesiologists (ASA) physical status of I-III and will undergo general anesthesia with endotracheal intubation and controlled mechanical ventilation. Participants will be recruited prospectively from patients scheduled for elective vNOTES surgery. All patients will receive standard surgical and anesthetic care without any study-specific intervention.
Who may be able to join
- Female patients aged 18 years or older.
- Scheduled for elective bilateral tubal ligation using the vaginal natural orifice transluminal endoscopic surgery (vNOTES) technique at Yahyali State Hospital.
- Requesting permanent contraception and considered surgically eligible for bilateral tubal ligation.
- American Society of Anesthesiologists (ASA) physical status I, II, or III.
- Scheduled to undergo general anesthesia with endotracheal intubation and controlled mechanical ventilation.
- Eligible for the standardized anesthesia and mechanical ventilation protocol.
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- No clinical condition preventing reliable intraoperative recording of ventilation parameters and respiratory mechanics.
- Willing to participate in the study and undergo the planned intraoperative measurements.
- Able to provide written informed consent.
Who cannot join
- Age younger than 18 years.
- Emergency surgery.
- Surgery performed using a technique other than vNOTES or conversion to conventional laparoscopy or open surgery.
- ASA physical status IV or higher.
- Severe chronic pulmonary disease, including severe chronic obstructive pulmonary disease, severe asthma, or interstitial lung disease.
- Uncontrolled cardiovascular disease or advanced heart failure.
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- Body mass index (BMI) ≥35 kg/m².
- Pregnancy or suspected pregnancy.
- Chest wall deformity or neuromuscular disease that may affect mechanical ventilation parameters.
- Missing or unreliable intraoperative measurements.
- Refusal to participate or failure to provide written informed consent.
About this study
Official title: Evaluation of the Effects of Trendelenburg Position and Pneumoperitoneum on Mechanical Power and Respiratory Mechanics During V-NOTES Surgery: A Prospective Observational Study
The purpose of this observational study is to evaluate the effects of Trendelenburg positioning and pneumoperitoneum on mechanical power and respiratory mechanics in adult women undergoing vaginal natural orifice transluminal endoscopic surgery (vNOTES) for bilateral tubal ligation.
The main questions this study aims to answer are:
Read more
- Does Trendelenburg positioning and pneumoperitoneum increase mechanical power during vNOTES surgery?
- How do Trendelenburg positioning and pneumoperitoneum affect respiratory mechanics, including driving pressure, lung compliance, and airway pressures?
Participants who are already scheduled to undergo vNOTES bilateral tubal ligation as part of their routine medical care will receive standard general anesthesia and mechanical ventilation. Researchers will record mechanical power and respiratory parameters at six predefined time points during surgery, before and after the application of pneumoperitoneum and Trendelenburg positioning.
A total of 14 adult women will be included. No additional experimental treatment or intervention will be performed as part of the study.
- Conditions
- Vnotes, Respiratory Mechanics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients Undergoing vNOTES Surgery | This cohort will include 14 adult female patients undergoing elective bilateral tubal ligation using the vaginal natural orifice transluminal endoscopic surgery (vNOTES) technique under general anesthesia with controlled mechanical ventilation. All participants will receive standard surgical and anesthetic care. Trendelenburg positioning and pneumoperitoneum will be performed as part of the routine surgical procedure. Mechanical power and respiratory mechanics parameters will be recorded at six predefined intraoperative time points to evaluate changes associated with Trendelenburg positioning and pneumoperitoneum. No additional experimental intervention or modification of routine clinical care will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Intraoperative Mechanical Power During vNOTES Surgery
Mechanical power (J/min) will be calculated using recorded mechanical ventilation parameters. Changes in mechanical power associated with pneumoperitoneum and Trendelenburg positioning will be evaluated at six predefined intraoperative time points (T0-T5). Kopyala
Measured: Intraoperatively, from immediately after endotracheal intubation to the end of surgery, at six predefined time points (T0-T5).
Secondary outcomes (3)
Changes in Intraoperative Driving Pressure
Description: Driving pressure (cmH₂O) will be calculated as plateau pressure minus positive end-expiratory pressure (Pplat - PEEP).
Measured: Intraoperatively, from immediately after endotracheal intubation to the end of surgery, at six predefined time points (T0-T5).
Changes in Static Respiratory System Compliance
Static respiratory system compliance (mL/cmH₂O) will be calculated using tidal volume and driving pressure (VT/[Pplat - PEEP]).
Measured: Intraoperatively, from immediately after endotracheal intubation to the end of surgery, at six predefined time points (T0-T5).
Changes in Dynamic Respiratory System Compliance
Dynamic respiratory system compliance (mL/cmH₂O) will be calculated using tidal volume and the difference between peak airway pressure and PEEP (VT/[Ppeak - PEEP]).
Measured: Intraoperatively, from immediately after endotracheal intubation to the end of surgery, at six predefined time points (T0-T5).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VnotesStudies 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
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Burcu Ayvazoğlu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Burcu Ayvazoğlu, Yahyali State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885111
- Sponsor's protocol ID
- Bayvazoglu
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Trendelenburg Position and Pneumoperitoneum on Mechanical Power and Respiratory Mechanics During V-NOTES Surgery: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07885111
- Acronym / sponsor ID
- Bayvazoglu
- Conditions
- Vnotes, Respiratory Mechanics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Burcu AyvazoğluUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this observational study is to evaluate the effects of Trendelenburg positioning and pneumoperitoneum on mechanical power and respiratory mechanics in adult women undergoing vaginal natural orifice transluminal endoscopic surgery (vNOTES) for bilateral tubal ligation.
The main questions this study aims to answer are:
- Does Trendelenburg positioning and pneumoperitoneum increase mechanical power during vNOTES surgery?
- How do Trendelenburg positioning and pneumoperitoneum affect respiratory mechanics, including driving pressure, lung compliance, and airway pressures?
Participants who are already scheduled to undergo vNOTES bilateral tubal ligation as part of their routine medical care will receive standard general anesthesia and mechanical ventilation. Researchers will record mechanical power and respiratory parameters at six predefined time points during surgery, before and after the application of pneumoperitoneum and Trendelenburg positioning.
A total of 14 adult women will be included. No additional experimental treatment or intervention will be performed as part of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Undergoing vNOTES Surgery | – | –This cohort will include 14 adult female patients undergoing elective bilateral tubal ligation using the vaginal natural orifice transluminal endoscopic surgery (vNOTES) technique under general anesthesia with controlled mechanical ventilation. All participants will receive standard surgical and anesthetic care. Trendelenburg positioning and pneumoperitoneum will be performed as part of the routine surgical procedure. Mechanical power and respiratory mechanics parameters will be recorded at six predefined intraoperative time points to evaluate changes associated with Trendelenburg positioning and pneumoperitoneum. No additional experimental intervention or modification of routine clinical care will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of 14 adult female patients aged 18 years or older who are scheduled to undergo elective bilateral tubal ligation using the vaginal natural orifice transluminal endoscopic surgery (vNOTES) technique at Yahyali State Hospital, Kayseri, Türkiye. Eligible participants will have an American Society of Anesthesiologists (ASA) physical status of I-III and will undergo general anesthesia with endotracheal intubation and controlled mechanical ventilation. Participants will be recruited prospectively from patients scheduled for elective vNOTES surgery. All patients will receive standard surgical and anesthetic care without any study-specific intervention.
Key inclusion criteria (9 listed)
- Female patients aged 18 years or older.
- Scheduled for elective bilateral tubal ligation using the vaginal natural orifice transluminal endoscopic surgery (vNOTES) technique at Yahyali State Hospital.
- Requesting permanent contraception and considered surgically eligible for bilateral tubal ligation.
- American Society of Anesthesiologists (ASA) physical status I, II, or III.
- Scheduled to undergo general anesthesia with endotracheal intubation and controlled mechanical ventilation.
Key exclusion criteria (11 listed)
- Age younger than 18 years.
- Emergency surgery.
- Surgery performed using a technique other than vNOTES or conversion to conventional laparoscopy or open surgery.
- ASA physical status IV or higher.
- Severe chronic pulmonary disease, including severe chronic obstructive pulmonary disease, severe asthma, or interstitial lung disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in Intraoperative Mechanical Power During vNOTES Surgery
Time frame: Intraoperatively, from immediately after endotracheal intubation to the end of surgery, at six predefined time points (T0-T5).
Mechanical power (J/min) will be calculated using recorded mechanical ventilation parameters. Changes in mechanical power associated with pneumoperitoneum and Trendelenburg positioning will be evaluated at six predefined intraoperative time points (T0-T5). Kopyala
3 secondary outcomes
Changes in Intraoperative Driving Pressure
Time frame: Intraoperatively, from immediately after endotracheal intubation to the end of surgery, at six predefined time points (T0-T5).
Changes in Static Respiratory System Compliance
Time frame: Intraoperatively, from immediately after endotracheal intubation to the end of surgery, at six predefined time points (T0-T5).
Changes in Dynamic Respiratory System Compliance
Time frame: Intraoperatively, from immediately after endotracheal intubation to the end of surgery, at six predefined time points (T0-T5).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Vnotes and Respiratory Mechanics, run by Burcu Ayvazoğlu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Intraoperative Mechanical Power During vNOTES Surgery (time frame: Intraoperatively, from immediately after endotracheal intubation to the end of surgery, at six predefined time points (T0-T5).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.