Mechanical VentilationNCT06861959
Comparison Volume-controlled Ventilation, Pressure-controlled Volume-guaranteed Ventilation, and Pressure-controlled Ventilation During Gynecologic Laparoscopic Surgery in the Steep Trendelenburg Position
A study of Mechanical Ventilation and Laparoscopic Gynecologic Surgery, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Objective: This study aimed to compare the effects of three different mechanical ventilation modes-Volume-Controlled Ventilation (VCV), Pressure-Controlled Ventilation (PCV), and Pressure-Controlled Volume-Guaranteed Ventilation (PCV-VG)-on pulmonary and hemodynamic variables during laparoscopic gynecologic surgery in… Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Mechanical Ventilation, Laparoscopic Gynecologic Surgery, Peak Inspiratuar Pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The study included patients aged 20-65 years
- Classified as American Society of Anesthesiologists (ASA) physical status I or III
- who were scheduled to undergo an elective laparoscopic gynecologic surgery with pneumoperitoneum lasting at least one hour in the steep Trendelenburg position.
Who cannot join
- morbid obesity (BMI > 40 kg/m²)
- pulmonary or cardiac diseases (e.g., chronic obstructive pulmonary disease, heart failure)
- a history of difficult intubation
- Patients requiring conversion to laparotomy or experiencing hemodynamic instability during surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zeynep Kamil Maternity and Children's Training and Research Hospital
Istanbul, Üsküdar
About this study
Official title: Comparison Volume-controlled Ventilation, Pressure-controlled Volume-guaranteed Ventilation, and Pressure-controlled Ventilation During Gynecologic Laparoscopic Surgery in the Steep Trendelenburg Position: A Randomized Controlled Trial
Objective:
This study aimed to compare the effects of three different mechanical ventilation modes-Volume-Controlled Ventilation (VCV), Pressure-Controlled Ventilation (PCV), and Pressure-Controlled Volume-Guaranteed Ventilation (PCV-VG)-on pulmonary and hemodynamic variables during laparoscopic gynecologic surgery in the steep Trendelenburg position. The hypothesis was that PCV and PCV-VG would be superior to VCV in optimizing respiratory mechanics and improving oxygenation, particularly by reducing peak inspiratory pressure (Ppeak).
Read more
Methods:
Prospective, randomized, controlled clinical trial. Sixty ASA I-III patients aged 20-65 years undergoing elective laparoscopic gynecologic surgery in the steep Trendelenburg position were included (20 patients per ventilation group).
Patients were randomized into VCV, PCV, and PCV-VG groups. Intraoperative ventilation was performed with a tidal volume of 8 mL/kg, PEEP of 5 cmH2O, and intra-abdominal pressure maintained at 12-14 mmHg.
Data were collected at four time points: T1 (after induction, supine), T2 (30 min after CO2 insufflation, Trendelenburg), T3 (60 min after pneumoperitoneum), and T4 (after CO2 deflation, supine).
Primary outcome: Ppeak comparison between groups. Secondary outcomes: Dynamic lung compliance (Cdyn), mean inspiratory pressure (Pmean), gas exchange, and hemodynamic parameters.
- Being tested
- Device: Volume-Controlled Ventilation (VCV), Device: Pressure-Controlled Ventilation (PCV), Device: Pressure-Controlled Volume-Guaranteed Ventilation (PCV-VG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: Volume-Controlled Ventilation (VCV)Device
Tidal volume: 8 mL/kg of ideal body weight Respiratory rate adjusted to maintain an end-tidal CO₂ (EtCO₂) level of 30-35 mmHg Inspiratory-expiratory ratio: 1:2 PEEP: 5 cmH₂O Mechanical ventilation was provided using a Datex-Ohmeda Avance Anesthesia Machine (GE Healthcare, USA) Measurements were taken at four predefined time points (T1-T4)
Device: Pressure-Controlled Ventilation (PCV)Device
Initial peak inspiratory pressure adjusted to deliver a tidal volume of 8 mL/kg of ideal body weight Respiratory rate adjusted to maintain an end-tidal CO₂ (EtCO₂) level of 30-35 mmHg Inspiratory-expiratory ratio: 1:2 PEEP: 5 cmH₂O Mechanical ventilation was provided using a Datex-Ohmeda Avance Anesthesia Machine (GE Healthcare, USA) Measurements were taken at four predefined time points (T1-T4)
Device: Pressure-Controlled Volume-Guaranteed Ventilation (PCV-VG)Device
Pressure-controlled mode with volume guarantee to maintain a tidal volume of 8 mL/kg of ideal body weight Respiratory rate adjusted to maintain an end-tidal CO₂ (EtCO₂) level of 30-35 mmHg Inspiratory-expiratory ratio: 1:2 PEEP: 5 cmH₂O Mechanical ventilation was provided using a Datex-Ohmeda Avance Anesthesia Machine (GE Healthcare, USA) Measurements were taken at four predefined time points (T1-T4)
| Study group | Role | What they receive |
|---|---|---|
| Group VCV | Active comparator | Patients in this group were ventilated using Volume-Controlled Ventilation (VCV) mode throughout the procedure. Receives: Device: Device: Volume-Controlled Ventilation (VCV) |
| Group PCV | Active comparator | Patients in this group were ventilated using Pressure-Controlled Ventilation (PCV) mode throughout the procedure. Receives: Device: Device: Pressure-Controlled Ventilation (PCV) |
| Group PCV-VG | Active comparator | Patients in this group were ventilated using Pressure-Controlled Volume-Guaranteed Ventilation (PCV-VG) mode throughout the procedure. Receives: Device: Device: Pressure-Controlled Volume-Guaranteed Ventilation (PCV-VG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak inspiratory pressure (Ppeak) among the groups
The primary outcome of the study was to compare peak inspiratory pressure (Ppeak) (cmH₂O) among the VCV, PCV, and PCV-VG ventilation modes in patients undergoing laparoscopic gynecologic surgery in the steep Trendelenburg position. Data were collected at four predefined time points during the study.
The first time point (T1) was measured 15 minutes after the induction of anesthesia, with patients in the supine position. The second time point (T2) was recorded 30 minutes following CO₂ insufflation and positioning in the Trendelenburg position. The third time point (T3) represented measurements taken 60 minutes after the initiation of pneumoperitoneum. The final time point (T4) was assessed 15 minutes after CO₂ deflation and the return of patients to the supine position.
Measured: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
Secondary outcomes (12)
Mean Inspiratory Pressure (Pmean) (cmH₂O) among the groups
Mean Inspiratory Pressure (Pmean) (cmH₂O)
Ventilation variables was recorded at T1 to T4.
Measured: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
Plateau Pressure (Pplateau) (cmH₂O) among the groups
Plateau Pressure (Pplateau) (cmH₂O)
Ventilation variables was recorded at T1 to T4.
Measured: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
Dynamic Lung Compliance (Cdyn) (mL/cmH₂O) among the groups
Dynamic Lung Compliance (Cdyn) (mL/cmH₂O)
Ventilation variables was recorded at T1 to T4.
Measured: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
Respiratory Rate (RR) (breaths per minute) among the groups
Respiratory Rate (RR) (breaths per minute)
Ventilation variables was recorded at T1 to T4.
Measured: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
Exhaled Tidal Volume (Exhale TV) (mL) among the groups
Exhaled Tidal Volume (Exhale TV) (mL)
Ventilation variables was recorded at T1 to T4.
Measured: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
Hemodynamic parameters: Heart Rate (HR) (beats per minute) among the groups
Heart Rate (HR) (beats per minute)
hemodynamic parameters were recorded at T1 to T4
Measured: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
Hemodynamic parameters:Mean Arterial Pressure (MAP) (mmHg) among the groups
Mean Arterial Pressure (MAP) (mmHg)
hemodynamic parameters were recorded at T1 to T4
Measured: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
Hemodynamic parameters: Peripheral Oxygen Saturation (SpO₂) (%) among the groups
Peripheral Oxygen Saturation (SpO₂) (%)
hemodynamic parameters were recorded at T1 to T4
Measured: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
Hemodynamic parameters:End-Tidal CO₂ (EtCO₂) (mmHg) among the groups
End-Tidal CO₂ (EtCO₂) (mmHg)
hemodynamic parameters were recorded at T1 to T4
Measured: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
arterial blood gas analysis: Arterial Partial Pressure of Oxygen (PaO₂) (mmHg) among the groups
Arterial Partial Pressure of Oxygen (PaO₂) (mmHg)
Arterial blood gas analysis was conducted at T1 and T3.
Measured: 15 minutes after the induction, 60 minutes after the initiation of pneumoperitoneum
arterial blood gas analysis: Arterial Partial Pressure of Oxygen (PaO₂) (mmHg) among the groups
Arterial Partial Pressure of Carbon Dioxide (PaCO₂) (mmHg)
Arterial blood gas analysis was conducted at T1 and T3.
Measured: 15 minutes after the induction, 60 minutes after the initiation of pneumoperitoneum
arterial blood gas analysis: Arterial Oxygen Saturation (SaO₂) (%) among the groups
Arterial Oxygen Saturation (SaO₂) (%)
Arterial blood gas analysis was conducted at T1 and T3.
Measured: 15 minutes after the induction, 60 minutes after the initiation of pneumoperitoneum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 Jan 2021
- Primary completion1 Aug 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, kübra taşkın, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861959
- Sponsor's protocol ID
- keahanest
- Status last verified
- Mar 2025
- First submitted
- 19 Feb 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Toker MK, Altiparmak B, Uysal AI, Demirbilek SG. [Comparison of pressure-controlled volume-guaranteed ventilation and volume-controlled ventilation in obese patients during gynecologic laparoscopic surgery in the Trendelenburg position]. Braz J Anesthesiol. 2019 Nov-Dec;69(6):553-560. doi: 10.1016/j.bjan.2019.09.003. Epub 2019 Dec 10.
PubMed 31836201
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Volume-controlled Ventilation, Pressure-controlled Volume-guaranteed Ventilation, and Pressure-controlled Ventilation During Gynecologic Laparoscopic Surgery in the Steep Trendelenburg Position: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06861959
- Acronym / sponsor ID
- keahanest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 6 Mar 2025 (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.
Objective:
This study aimed to compare the effects of three different mechanical ventilation modes-Volume-Controlled Ventilation (VCV), Pressure-Controlled Ventilation (PCV), and Pressure-Controlled Volume-Guaranteed Ventilation (PCV-VG)-on pulmonary and hemodynamic variables during laparoscopic gynecologic surgery in the steep Trendelenburg position. The hypothesis was that PCV and PCV-VG would be superior to VCV in optimizing respiratory mechanics and improving oxygenation, particularly by reducing peak inspiratory pressure (Ppeak).
Methods:
Prospective, randomized, controlled clinical trial. Sixty ASA I-III patients aged 20-65 years undergoing elective laparoscopic gynecologic surgery in the steep Trendelenburg position were included (20 patients per ventilation group).
Patients were randomized into VCV, PCV, and PCV-VG groups. Intraoperative ventilation was performed with a tidal volume of 8 mL/kg, PEEP of 5 cmH2O, and intra-abdominal pressure maintained at 12-14 mmHg.
Data were collected at four time points: T1 (after induction, supine), T2 (30 min after CO2 insufflation, Trendelenburg), T3 (60 min after pneumoperitoneum), and T4 (after CO2 deflation, supine).
Primary outcome: Ppeak comparison between groups. Secondary outcomes: Dynamic lung compliance (Cdyn), mean inspiratory pressure (Pmean), gas exchange, and hemodynamic parameters.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group VCV | Active comparator | Device: Device: Volume-Controlled Ventilation (VCV)Patients in this group were ventilated using Volume-Controlled Ventilation (VCV) mode throughout the procedure. |
| Group PCV | Active comparator | Device: Device: Pressure-Controlled Ventilation (PCV)Patients in this group were ventilated using Pressure-Controlled Ventilation (PCV) mode throughout the procedure. |
| Group PCV-VG | Active comparator | Device: Device: Pressure-Controlled Volume-Guaranteed Ventilation (PCV-VG)Patients in this group were ventilated using Pressure-Controlled Volume-Guaranteed Ventilation (PCV-VG) mode throughout the procedure. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The study included patients aged 20-65 years
- Classified as American Society of Anesthesiologists (ASA) physical status I or III
- who were scheduled to undergo an elective laparoscopic gynecologic surgery with pneumoperitoneum lasting at least one hour in the steep Trendelenburg position.
Key exclusion criteria (4 listed)
- morbid obesity (BMI > 40 kg/m²)
- pulmonary or cardiac diseases (e.g., chronic obstructive pulmonary disease, heart failure)
- a history of difficult intubation
- Patients requiring conversion to laparotomy or experiencing hemodynamic instability during surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device: Volume-Controlled Ventilation (VCV)Tidal volume: 8 mL/kg of ideal body weight Respiratory rate adjusted to maintain an end-tidal CO₂ (EtCO₂) level of 30-35 mmHg Inspiratory-expiratory ratio: 1:2 PEEP: 5 cmH₂O Mechanical ventilation was provided using a Datex-Ohmeda Avance Anesthesia Machine (GE Healthcare, USA) Measurements were taken at four predefined time points (T1-T4) | Device | Group VCV |
| Device: Pressure-Controlled Ventilation (PCV)Initial peak inspiratory pressure adjusted to deliver a tidal volume of 8 mL/kg of ideal body weight Respiratory rate adjusted to maintain an end-tidal CO₂ (EtCO₂) level of 30-35 mmHg Inspiratory-expiratory ratio: 1:2 PEEP: 5 cmH₂O Mechanical ventilation was provided using a Datex-Ohmeda Avance Anesthesia Machine (GE Healthcare, USA) Measurements were taken at four predefined time points (T1-T4) | Device | Group PCV |
| Device: Pressure-Controlled Volume-Guaranteed Ventilation (PCV-VG)Pressure-controlled mode with volume guarantee to maintain a tidal volume of 8 mL/kg of ideal body weight Respiratory rate adjusted to maintain an end-tidal CO₂ (EtCO₂) level of 30-35 mmHg Inspiratory-expiratory ratio: 1:2 PEEP: 5 cmH₂O Mechanical ventilation was provided using a Datex-Ohmeda Avance Anesthesia Machine (GE Healthcare, USA) Measurements were taken at four predefined time points (T1-T4) | Device | Group PCV-VG |
Primary outcome
peak inspiratory pressure (Ppeak) among the groups
Time frame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
The primary outcome of the study was to compare peak inspiratory pressure (Ppeak) (cmH₂O) among the VCV, PCV, and PCV-VG ventilation modes in patients undergoing laparoscopic gynecologic surgery in the steep Trendelenburg position. Data were collected at four predefined time points during the study. The first time point (T1) was measured 15 minutes after the induction of anesthesia, with patients in the supine position. The second time point (T2) was recorded 30 minutes following CO₂ insufflation and positioning in the Trendelenburg position. The third time point (T3) represented measurements taken 60 minutes after the initiation of pneumoperitoneum. The final time point (T4) was assessed 15 minutes after CO₂ deflation and the return of patients to the supine position.
12 secondary outcomes
Mean Inspiratory Pressure (Pmean) (cmH₂O) among the groups
Time frame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
Plateau Pressure (Pplateau) (cmH₂O) among the groups
Time frame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
Dynamic Lung Compliance (Cdyn) (mL/cmH₂O) among the groups
Time frame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
Respiratory Rate (RR) (breaths per minute) among the groups
Time frame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
Exhaled Tidal Volume (Exhale TV) (mL) among the groups
Time frame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
Hemodynamic parameters: Heart Rate (HR) (beats per minute) among the groups
Time frame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
Hemodynamic parameters:Mean Arterial Pressure (MAP) (mmHg) among the groups
Time frame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
Hemodynamic parameters: Peripheral Oxygen Saturation (SpO₂) (%) among the groups
Time frame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
Hemodynamic parameters:End-Tidal CO₂ (EtCO₂) (mmHg) among the groups
Time frame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
arterial blood gas analysis: Arterial Partial Pressure of Oxygen (PaO₂) (mmHg) among the groups
Time frame: 15 minutes after the induction, 60 minutes after the initiation of pneumoperitoneum
arterial blood gas analysis: Arterial Partial Pressure of Oxygen (PaO₂) (mmHg) among the groups
Time frame: 15 minutes after the induction, 60 minutes after the initiation of pneumoperitoneum
arterial blood gas analysis: Arterial Oxygen Saturation (SaO₂) (%) among the groups
Time frame: 15 minutes after the induction, 60 minutes after the initiation of pneumoperitoneum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Background: PubMed 31836201Toker MK, Altiparmak B, Uysal AI, Demirbilek SG. [Comparison of pressure-controlled volume-guaranteed ventilation and volume-controlled ventilation in obese patients during gynecologic laparoscopic surgery in the Trendelenburg position]. Braz J Anesthesiol. 2019 Nov-Dec;69(6):553-560. doi: 10.1016/j.bjan.2019.09.003. Epub 2019 Dec 10.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Mechanical Ventilation and Laparoscopic Gynecologic Surgery, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
peak inspiratory pressure (Ppeak) among the groups (time frame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06861959, which also lists 1 linked publication.
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 10 Mar 2025.