Laparoscopic SurgeryNCT06805747
A Comparative Study of Ventilation Strategies in Different Surgical Positions on Intracranial Pressure and Cerebral Blood Flow During Laparoscopic Surgery
A study testing Variable tidal volume ventilation (V-VCV) and Trendelenburg position in people with Laparoscopic Surgery, run by Inner Mongolia Baogang Hospital at 1 site in China.
Trial summary
The purpose of this clinical trial is to investigate the effects of laparoscopic surgery in the Trendelenburg and Reverse Trendelenburg positions, and variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Laparoscopic Surgery
- What is being tested?
- Variable tidal volume ventilation (V-VCV) and Trendelenburg position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 10 May 2025
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: Unrestricted
- American Society of Anesthesiologists (ASA) Physical Status: Class I-III
- Surgical Position: Requires the use of either the Trendelenburg position or the Reverse Trendelenburg position during the procedure.
- Ventilation: Planned mechanical ventilation is required during the procedure, with suitability for one of the following modes: pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), or pressure-controlled ventilation (PCV).
Who cannot join
- Significant Cardiopulmonary Disease:
- Intracranial Disease
- Severe Coagulopathy or Current Anticoagulant Therapy
- Presence of Psychiatric Illness, Cognitive Impairment, or other condition that precludes the ability to understand or comply with the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Inner Mongolia Baogang Hospital
Baotou, Inner Mongolia, 014010
Xiangyu Wang XY Wang, Undergraduate, +86 0472 5992830, KevinDuan0901@gmail.com
Xiaoyu Zhang
About this study
The purpose of this clinical trial is to investigate the effects of laparoscopic surgery in the Trendelenburg and Reverse Trendelenburg positions, and variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), and pressure-controlled ventilation (PCV) on esophageal pressure, airway pressure, tidal volume, intracranial pressure, and cerebral blood flow.
The study aims to address the following primary questions:Does laparoscopic surgery in the Trendelenburg or Reverse Trendelenburg position increase esophageal pressure, airway pressure, and intracranial pressure, and decrease tidal volume and cerebral blood flow? Do variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), or pressure-controlled ventilation (PCV) increase esophageal pressure, airway pressure, and intracranial pressure, and decrease tidal volume and cerebral blood flow? The investigators will compare variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), and pressure-controlled ventilation (PCV) to determine which ventilation mode results in the least physiological disturbance for patients.
Read more
Participant Procedures:
Participants will: Be positioned according to the surgical requirements.Be randomly assigned to mechanical ventilation with either variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), or pressure-controlled ventilation (PCV).
Undergo assessments at the following time points: immediately after endotracheal intubation, immediately after pneumoperitoneum, immediately after position change (Trendelenburg or Reverse Trendelenburg), 30 minutes after position change, and 1 hour after position change.
Have their esophageal pressure, airway pressure, intracranial pressure, tidal volume, and internal jugular vein blood flow recorded at each assessment time point.
- Conditions
- Laparoscopic Surgery
- Being tested
- Variable tidal volume ventilation (V-VCV), Pressure-regulated volume-controlled ventilation (PRVC), Conventional volume-controlled ventilation (C-VCV), Pressure-controlled ventilation (PCV), Trendelenburg position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Variable tidal volume ventilation (V-VCV)Other
Variable tidal volume ventilation (V-VCV) ：The initial tidal volume is set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW), and the maximum tidal volume (Vt_max) and minimum tidal volume (Vt_min) are set at 10-20% of the base tidal volume (Vt_base). Respiratory Rate 12. Inspiratory Flow Rate (IFR) 60L/min, Inspiration to Expiration Ratio (IER) 1:2, Positive End-Expiratory Pressure (PEEP) 5 cm water column, and Inhaled Oxygen Concentration (FiO2) 41%.
Pressure-regulated volume-controlled ventilation (PRVC)Other
Pressure-regulated volume-controlled ventilation (PRVC) ：Initial tidal volume is set at 6-8 ml/kg IBW based on Ideal Body Weight (IBW), peak inspiratory pressure is capped at 30 cmH2O, maximum tidal volume (Vt_max), and minimum tidal volume (Vt_min) is set at 10-20% of basal tidal volume (Vt_base). Respiratory Rate (RR) 12, Inspiratory Breathing Ratio (IBR) 1:2, Positive End-Expiratory Pressure (PEEP) 5 cm water column, and Inhaled Oxygen Concentration (FiO2) 98%.
Conventional volume-controlled ventilation (C-VCV)Other
Conventional volume-controlled ventilation (C-VCV) ：The initial tidal volume is set at 6-8 ml/kg IBW based on Ideal Body Weight (IBW), and the maximum tidal volume (Vt_max) and minimum tidal volume (Vt_min) are set at 10-20% of the basal tidal volume (Vt_base). Respiratory Rate 12. Inspiratory Flow Rate (IFR) 60L/min, Inspiration to Expiration Ratio (IER) 1:2, Positive End-Expiratory Pressure (PEEP) 5cm water column, FiO2 98%.
Pressure-controlled ventilation (PCV)Other
Pressure-controlled ventilation (PCV)：Set inspiratory pressure level, usually 20 cmH2O initial value, Respiratory Rate 12, Inspiratory to Expiratory Ratio 1:2, Positive End-Expiratory Pressure (PEEP) 5 cm water column, Inhaled Oxygen Concentration (FiO2) 98%.
Trendelenburg positionOther
Trendelenburg position：Lower the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt.
Reverse Trendelenburg positionOther
Reverse Trendelenburg position：Elevate the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt.
| Study group | Role | What they receive |
|---|---|---|
| T-V-VCV Group | Experimental | Variable tidal volume ventilation (V-VCV) ：The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW).The maximum tidal volume (Vt_max) and minimum tidal volume (Vt_min) were set at 10-20% of the basal tidal volume (Vt_base). Respiratory Rate 12. Inspiratory Flow Rate (IFR) 60L/min, Inspiratory to Expiratory Ratio (IER) 1:2, Positive End-Expiratory Pressure (PEEP) 5cm water column, and Inhaled Oxygen Concentration (FiO2) 41%.
Use of the trendelenburg position：Lower the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt. Receives: Other: Variable tidal volume ventilation (V-VCV); Other: Trendelenburg position |
| T-PRVC Group | Experimental | Pressure-regulated volume-controlled ventilation (PRVC) ：The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW), the upper limit of peak inspiratory pressure was 30 cmH2O, the maximum tidal volume (Vt_max) and the minimum tidal volume (Vt_min) was set at 10-20% of the base tidal volume (Vt_base). Respiratory Rate is 12, Inspiration to Expiration Ratio is 1:2, Positive End-Expiratory Pressure (PEEP) is 5cmH2O, and Inhaled Oxygen Concentration (FiO2) is 98%.
Use of the trendelenburg position：Lower the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt. Receives: Other: Pressure-regulated volume-controlled ventilation (PRVC); Other: Trendelenburg position |
| T-C-VCV Group | Experimental | Conventional volume-controlled ventilation (C-VCV)The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW).The maximum tidal volume (Vt_max) and minimum tidal volume (Vt_min) were set at 10-20% of the basal tidal volume (Vt_base). Respiratory Rate 12.Inspiratory Flow Rate (IFR) 60L/min, Inspiratory to Expiratory Ratio (IER) 1:2, Positive End-Expiratory Pressure (PEEP) 5cm water column, and Inhaled Oxygen Concentration (FiO2) 98%.
Use of the trendelenburg position：Lower the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt. Receives: Other: Conventional volume-controlled ventilation (C-VCV); Other: Trendelenburg position |
| T-PVC Group | Experimental | Pressure-controlled ventilation (PCV)：The inspiratory pressure level is set, usually with an initial value of 20 cmH2O, a respiratory rate of 12, an inspiratory/expiratory ratio of 1:2, a positive end-expiratory pressure (PEEP) of 5 cm water column, and an inspired oxygen concentration (FiO2) of 98%.
Use of the trendelenburg position：Lower the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt. Receives: Other: Pressure-controlled ventilation (PCV); Other: Trendelenburg position |
| R-V-VCV Group | Experimental | Variable tidal volume ventilation (V-VCV) ：The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW).The maximum tidal volume (Vt_max) and minimum tidal volume (Vt_min) were set at 10-20% of the basal tidal volume (Vt_base). Respiratory Rate 12. Inspiratory Flow Rate (IFR) 60L/min, Inspiratory to Expiratory Ratio (IER) 1:2, Positive End-Expiratory Pressure (PEEP) 5cm water column, and Inhaled Oxygen Concentration (FiO2) 41%.
Use of the reverse trendelenburg position：Elevate the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt. Receives: Other: Variable tidal volume ventilation (V-VCV); Other: Reverse Trendelenburg position |
| R-PRVC Group | Experimental | Pressure-regulated volume-controlled ventilation (PRVC) ：The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW), the upper limit of peak inspiratory pressure was 30 cmH2O, the maximum tidal volume (Vt_max) and the minimum tidal volume (Vt_min) was set at 10-20% of the base tidal volume (Vt_base). Respiratory Rate is 12, Inspiration to Expiration Ratio is 1:2, Positive End-Expiratory Pressure (PEEP) is 5cmH2O, and Inhaled Oxygen Concentration (FiO2) is 98%.
Use of the reverse trendelenburg position：Elevate the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt. Receives: Other: Pressure-regulated volume-controlled ventilation (PRVC); Other: Reverse Trendelenburg position |
| R-C-VCV Group | Experimental | Conventional volume-controlled ventilation (C-VCV)The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW).The maximum tidal volume (Vt_max) and minimum tidal volume (Vt_min) were set at 10-20% of the basal tidal volume (Vt_base). Respiratory Rate 12.Inspiratory Flow Rate (IFR) 60L/min, Inspiratory to Expiratory Ratio (IER) 1:2, Positive End-Expiratory Pressure (PEEP) 5cm water column, and Inhaled Oxygen Concentration (FiO2) 98%.
Use of the reverse trendelenburg position：Elevate the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt. Receives: Other: Conventional volume-controlled ventilation (C-VCV); Other: Reverse Trendelenburg position |
| R-PVC Group | Experimental | Pressure-controlled ventilation (PCV)：The inspiratory pressure level is set, usually with an initial value of 20 cmH2O, a respiratory rate of 12, an inspiratory/expiratory ratio of 1:2, a positive end-expiratory pressure (PEEP) of 5 cm water column, and an inspired oxygen concentration (FiO2) of 98%.
Use of the reverse trendelenburg position：Elevate the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt. Receives: Other: Pressure-controlled ventilation (PCV); Other: Reverse Trendelenburg position |
What is being measured
The primary outcome is the main question the study is designed to answer.
esophageal pressure
Measured: immediately after tracheal intubation
airway pressure
Measured: immediately after tracheal intubation
intracranial pressure
Measured: immediately after pneumoperitoneum
tidal volume
Measured: immediately after tracheal intubation
carotid blood flow
Measured: half an hour after change of position
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion10 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic SurgeryStudies 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inner Mongolia Baogang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805747
- Sponsor's protocol ID
- 2024-MER-312
- Status last verified
- Jan 2025
- First submitted
- 19 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Ventilation Strategies in Different Surgical Positions on Intracranial Pressure and Cerebral Blood Flow During Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT06805747
- Acronym / sponsor ID
- 2024-MER-312
- Conditions
- Laparoscopic Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Inner Mongolia Baogang HospitalUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 10 May 2025 (estimated)
- First posted
- 3 Feb 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.
The purpose of this clinical trial is to investigate the effects of laparoscopic surgery in the Trendelenburg and Reverse Trendelenburg positions, and variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), and pressure-controlled ventilation (PCV) on esophageal pressure, airway pressure, tidal volume, intracranial pressure, and cerebral blood flow.
The study aims to address the following primary questions:Does laparoscopic surgery in the Trendelenburg or Reverse Trendelenburg position increase esophageal pressure, airway pressure, and intracranial pressure, and decrease tidal volume and cerebral blood flow? Do variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), or pressure-controlled ventilation (PCV) increase esophageal pressure, airway pressure, and intracranial pressure, and decrease tidal volume and cerebral blood flow? The investigators will compare variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), and pressure-controlled ventilation (PCV) to determine which ventilation mode results in the least physiological disturbance for patients.
Participant Procedures:
Participants will: Be positioned according to the surgical requirements.Be randomly assigned to mechanical ventilation with either variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), or pressure-controlled ventilation (PCV).
Undergo assessments at the following time points: immediately after endotracheal intubation, immediately after pneumoperitoneum, immediately after position change (Trendelenburg or Reverse Trendelenburg), 30 minutes after position change, and 1 hour after position change.
Have their esophageal pressure, airway pressure, intracranial pressure, tidal volume, and internal jugular vein blood flow recorded at each assessment time point.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| T-V-VCV Group | Experimental | Other: Variable tidal volume ventilation (V-VCV), Other: Trendelenburg positionVariable tidal volume ventilation (V-VCV) ：The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW).The maximum tidal volume (Vt_max) and minimum tidal volume (Vt_min) were set at 10-20% of the basal tidal volume (Vt_base). Respiratory Rate 12. Inspiratory Flow Rate (IFR) 60L/min, Inspiratory to Expiratory Ratio (IER) 1:2, Positive End-Expiratory Pressure (PEEP) 5cm water column, and Inhaled Oxygen Concentration (FiO2) 41%. Use of the trendelenburg position：Lower the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt. |
| T-PRVC Group | Experimental | Other: Pressure-regulated volume-controlled ventilation (PRVC), Other: Trendelenburg positionPressure-regulated volume-controlled ventilation (PRVC) ：The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW), the upper limit of peak inspiratory pressure was 30 cmH2O, the maximum tidal volume (Vt_max) and the minimum tidal volume (Vt_min) was set at 10-20% of the base tidal volume (Vt_base). Respiratory Rate is 12, Inspiration to Expiration Ratio is 1:2, Positive End-Expiratory Pressure (PEEP) is 5cmH2O, and Inhaled Oxygen Concentration (FiO2) is 98%. Use of the trendelenburg position：Lower the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt. |
| T-C-VCV Group | Experimental | Other: Conventional volume-controlled ventilation (C-VCV), Other: Trendelenburg positionConventional volume-controlled ventilation (C-VCV)The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW).The maximum tidal volume (Vt_max) and minimum tidal volume (Vt_min) were set at 10-20% of the basal tidal volume (Vt_base). Respiratory Rate 12.Inspiratory Flow Rate (IFR) 60L/min, Inspiratory to Expiratory Ratio (IER) 1:2, Positive End-Expiratory Pressure (PEEP) 5cm water column, and Inhaled Oxygen Concentration (FiO2) 98%. Use of the trendelenburg position：Lower the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt. |
| T-PVC Group | Experimental | Other: Pressure-controlled ventilation (PCV), Other: Trendelenburg positionPressure-controlled ventilation (PCV)：The inspiratory pressure level is set, usually with an initial value of 20 cmH2O, a respiratory rate of 12, an inspiratory/expiratory ratio of 1:2, a positive end-expiratory pressure (PEEP) of 5 cm water column, and an inspired oxygen concentration (FiO2) of 98%. Use of the trendelenburg position：Lower the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt. |
| R-V-VCV Group | Experimental | Other: Variable tidal volume ventilation (V-VCV), Other: Reverse Trendelenburg positionVariable tidal volume ventilation (V-VCV) ：The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW).The maximum tidal volume (Vt_max) and minimum tidal volume (Vt_min) were set at 10-20% of the basal tidal volume (Vt_base). Respiratory Rate 12. Inspiratory Flow Rate (IFR) 60L/min, Inspiratory to Expiratory Ratio (IER) 1:2, Positive End-Expiratory Pressure (PEEP) 5cm water column, and Inhaled Oxygen Concentration (FiO2) 41%. Use of the reverse trendelenburg position：Elevate the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt. |
| R-PRVC Group | Experimental | Other: Pressure-regulated volume-controlled ventilation (PRVC), Other: Reverse Trendelenburg positionPressure-regulated volume-controlled ventilation (PRVC) ：The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW), the upper limit of peak inspiratory pressure was 30 cmH2O, the maximum tidal volume (Vt_max) and the minimum tidal volume (Vt_min) was set at 10-20% of the base tidal volume (Vt_base). Respiratory Rate is 12, Inspiration to Expiration Ratio is 1:2, Positive End-Expiratory Pressure (PEEP) is 5cmH2O, and Inhaled Oxygen Concentration (FiO2) is 98%. Use of the reverse trendelenburg position：Elevate the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt. |
| R-C-VCV Group | Experimental | Other: Conventional volume-controlled ventilation (C-VCV), Other: Reverse Trendelenburg positionConventional volume-controlled ventilation (C-VCV)The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW).The maximum tidal volume (Vt_max) and minimum tidal volume (Vt_min) were set at 10-20% of the basal tidal volume (Vt_base). Respiratory Rate 12.Inspiratory Flow Rate (IFR) 60L/min, Inspiratory to Expiratory Ratio (IER) 1:2, Positive End-Expiratory Pressure (PEEP) 5cm water column, and Inhaled Oxygen Concentration (FiO2) 98%. Use of the reverse trendelenburg position：Elevate the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt. |
| R-PVC Group | Experimental | Other: Pressure-controlled ventilation (PCV), Other: Reverse Trendelenburg positionPressure-controlled ventilation (PCV)：The inspiratory pressure level is set, usually with an initial value of 20 cmH2O, a respiratory rate of 12, an inspiratory/expiratory ratio of 1:2, a positive end-expiratory pressure (PEEP) of 5 cm water column, and an inspired oxygen concentration (FiO2) of 98%. Use of the reverse trendelenburg position：Elevate the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age: Unrestricted
- American Society of Anesthesiologists (ASA) Physical Status: Class I-III
- Surgical Position: Requires the use of either the Trendelenburg position or the Reverse Trendelenburg position during the procedure.
- Ventilation: Planned mechanical ventilation is required during the procedure, with suitability for one of the following modes: pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), or pressure-controlled ventilation (PCV).
Key exclusion criteria (4 listed)
- Significant Cardiopulmonary Disease:
- Intracranial Disease
- Severe Coagulopathy or Current Anticoagulant Therapy
- Presence of Psychiatric Illness, Cognitive Impairment, or other condition that precludes the ability to understand or comply with the study.
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 |
|---|---|---|
| Variable tidal volume ventilation (V-VCV)Variable tidal volume ventilation (V-VCV) ：The initial tidal volume is set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW), and the maximum tidal volume (Vt_max) and minimum tidal volume (Vt_min) are set at 10-20% of the base tidal volume (Vt_base). Respiratory Rate 12. Inspiratory Flow Rate (IFR) 60L/min, Inspiration to Expiration Ratio (IER) 1:2, Positive End-Expiratory Pressure (PEEP) 5 cm water column, and Inhaled Oxygen Concentration (FiO2) 41%. | Other | R-V-VCV Group, T-V-VCV Group |
| Pressure-regulated volume-controlled ventilation (PRVC)Pressure-regulated volume-controlled ventilation (PRVC) ：Initial tidal volume is set at 6-8 ml/kg IBW based on Ideal Body Weight (IBW), peak inspiratory pressure is capped at 30 cmH2O, maximum tidal volume (Vt_max), and minimum tidal volume (Vt_min) is set at 10-20% of basal tidal volume (Vt_base). Respiratory Rate (RR) 12, Inspiratory Breathing Ratio (IBR) 1:2, Positive End-Expiratory Pressure (PEEP) 5 cm water column, and Inhaled Oxygen Concentration (FiO2) 98%. | Other | R-PRVC Group, T-PRVC Group |
| Conventional volume-controlled ventilation (C-VCV)Conventional volume-controlled ventilation (C-VCV) ：The initial tidal volume is set at 6-8 ml/kg IBW based on Ideal Body Weight (IBW), and the maximum tidal volume (Vt_max) and minimum tidal volume (Vt_min) are set at 10-20% of the basal tidal volume (Vt_base). Respiratory Rate 12. Inspiratory Flow Rate (IFR) 60L/min, Inspiration to Expiration Ratio (IER) 1:2, Positive End-Expiratory Pressure (PEEP) 5cm water column, FiO2 98%. | Other | R-C-VCV Group, T-C-VCV Group |
| Pressure-controlled ventilation (PCV)Pressure-controlled ventilation (PCV)：Set inspiratory pressure level, usually 20 cmH2O initial value, Respiratory Rate 12, Inspiratory to Expiratory Ratio 1:2, Positive End-Expiratory Pressure (PEEP) 5 cm water column, Inhaled Oxygen Concentration (FiO2) 98%. | Other | R-PVC Group, T-PVC Group |
| Trendelenburg positionTrendelenburg position：Lower the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt. | Other | T-C-VCV Group, T-PRVC Group, T-PVC Group, T-V-VCV Group |
| Reverse Trendelenburg positionReverse Trendelenburg position：Elevate the head of the bed by 30 degrees with no more than 15 degrees of lateral tilt. | Other | R-C-VCV Group, R-PRVC Group, R-PVC Group, R-V-VCV Group |
Primary outcome
esophageal pressure
Time frame: immediately after tracheal intubation
airway pressure
Time frame: immediately after tracheal intubation
intracranial pressure
Time frame: immediately after pneumoperitoneum
tidal volume
Time frame: immediately after tracheal intubation
carotid blood flow
Time frame: half an hour after change of position
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 3 Feb 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Variable tidal volume ventilation (V-VCV) and Trendelenburg position in people with Laparoscopic Surgery, run by Inner Mongolia Baogang Hospital at 1 site in China.
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 4 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: opening soon, as of the sponsor's last update on 3 Feb 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 China. 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?
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?
Contact Xiaguang XG Duan, Master's degree (+86 13314720012, alonlord2023@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
esophageal pressure (time frame: immediately after tracheal intubation). The study lists 5 primary outcomes in all. 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 3 Feb 2025.