VentilationNCT06547411
Effects of Different Anesthesia Machine Modalities on Bariatric Surgery Patients: a Prospective Randomized Controlled Study
A study testing PC Ventilation mode, VC Ventilation mode and PRVC Ventilation mode in people with Ventilation and Bariatric Surgery, run by Yu-Long Jia at 1 site in China.
Trial summary
The goal of this clinical trial is to explore the clinical significance and value of the PRVC ventilation mode in Bariatric Surgery Patients. The main questions it aims to answer are： Do different ventilation patterns affect intracranial pressure and partial pressure of carbon dioxide in bariatric surgery patients?… Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventilation, Bariatric Surgery, Intracranial Pressure
- What is being tested?
- PC Ventilation mode, VC Ventilation mode and PRVC Ventilation mode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 30 Mar 2025
- 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 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients scheduled for elective bariatric surgery.
- Age between 16 and 65 years.
- Continuous weight gain for more than 5 years with a BMI ≥ 35.
- ASA-PS (American Society of Anesthesiologists Physical Status) categorization of Grade II or III.
Who cannot join
- Patients who were dependent on alcohol or opioids.
- Patients with severe mental or intellectual disabilities.
- Patients with severe ocular conditions, such as ocular trauma, optic nerve tumors, or those wearing ocular prostheses.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Inner Mongolia Baogang Hospital
Baotou, Inner Mongolia, 014010
Yu-Long Jia, 14747606821, jiayulong97@gmail.com
About this study
Official title: Effects of Different Ventilation Modes on Intracranial Pressure and Carbon Dioxide Partial Pressure During Bariatric Surgery: a Prospective, Randomized, Controlled Study
The goal of this clinical trial is to explore the clinical significance and value of the PRVC ventilation mode in Bariatric Surgery Patients. The main questions it aims to answer are：
- Do different ventilation patterns affect intracranial pressure and partial pressure of carbon dioxide in bariatric surgery patients?
- Does PRVC mode reduce intracranial pressure and partial pressure of carbon dioxide in bariatric surgery patients?
- Whether intracranial pressure can be quickly measured by monitoring a patient's optic nerve sheath diameter (ONSD)？ Researchers randomized bariatric surgery patients into PC, VC, and PRVC groups for comparison, looking at breathing mechanics, PaCO2, and ICP.
Read more
Participants will:
- take PC mode ventilation, VC mode ventilation, and PRVC mode ventilation
- monitor Respiratory mechanics, PaCO2, and ONSD
- Conditions
- Ventilation, Bariatric Surgery, Intracranial Pressure, Carbon Dioxide
- Being tested
- PC Ventilation mode, VC Ventilation mode, PRVC Ventilation mode
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PC Ventilation modeDevice
Patients were randomly assigned to three groups using a random number table and the random remainder grouping method at a ratio of 1:1:1. Group I received pressure control ventilation (PC).
VC Ventilation modeDevice
Patients were randomly assigned to three groups using a random number table and the random remainder grouping method at a ratio of 1:1:1. Group II received volume control ventilation (VC).
PRVC Ventilation modeDevice
Patients were randomly assigned to three groups using a random number table and the random remainder grouping method at a ratio of 1:1:1. Group III received pressure-regulated volume control ventilation (PRVC).
| Study group | Role | What they receive |
|---|---|---|
| PC Ventilation mode group | Experimental | Group I patients received mechanical ventilation using the PC mode. The anesthetic machine (MAQUET Flow-I, Italy) parameters were set as follows: The inspiratory pressure (Pins) was adjusted to maintain an end-tidal carbon dioxide concentration (ETCO2) of 4.0-5.0 kPa. Pure oxygen and air were utilized at 0.3 L/min each, with an oxygen content of 41%. Receives: Device: PC Ventilation mode |
| VC Ventilation mode group | Experimental | Group II patients received mechanical ventilation in VC mode. The tidal volume during regulated breathing was determined based on the ideal body weight (IBW): 6-8 ml/kg (IBW for males: 50 + 0.91 × (height [cm] - 152.4); IBW for females: 45.5 + 0.91 × (height [cm] - 152.4). The positive end-expiratory pressure (PEEP) was set at 10 cmH2O, with an inspiration-to-expiration ratio of 1:2, a respiratory rate of 16 breaths per minute, and an oxygen content of 41% Receives: Device: VC Ventilation mode |
| PRVC Ventilation mode group | Experimental | Group III patients received mechanical ventilation using the PRVC mode.The tidal volume during regulated breathing was determined based on the ideal body weight (IBW): 6-8 ml/kg (IBW for males: 50 + 0.91 × (height [cm] - 152.4); IBW for females: 45.5 + 0.91 × (height [cm] - 152.4). The positive end-expiratory pressure (PEEP) was set at 10 cmH2O, with an inspiration-to-expiration ratio of 1:2, a respiratory rate of 16 breaths per minute, and an oxygen content of 41% Receives: Device: PRVC Ventilation mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
optic nerve sheath diameter [ONSD]
Patients were positioned supine with their eyes softly closed, and their eyes were protected with disposable transparent patches. A 7.5 MHz linear probe (Micromaxx Ultrasound System; SonoSite Inc., Bothell, WA, USA) was gently placed on the closed upper eyelid without applying pressure to the eyeball, and sufficient ultrasound gel was applied to ensure clear imaging. The optic nerve sheath was checked and measured 3 mm beyond the globe, and three ONSD measures were performed, with the average value utilized as the final ONSD measurement, which was accurate to 0.01 mm.
Measured: 1 year
carbon dioxide partial pressure
Arterial blood carbon dioxide partial pressure, is an important indicator of alveolar ventilation, reflecting the respiratory factors in acid-base balance. Its reference value is usually 35-45 mmHg.
Measured: 1 year
mean airway pressure (PAWM)
Mean airway pressure throughout the ventilation cycle
Measured: 1 year
peak airway pressure (PAP)
Maximum pressure in the airway throughout inspiration
Measured: 1 year
esophageal pressure (PES)
Esophageal manometry is the recording of pressure changes in various parts of the esophagus at rest and after swallowing, and is used to indicate the motor function of the upper and lower esophageal sphincters and the body of the esophagus, and to understand esophageal motility
Measured: 1 year
tidal volume (TV)
Tidal volume is the volume of gas inhaled or exhaled each time when breathing calmly, it is an indicator to show lung volume, mainly used for ventilation function test in pulmonary function test. Tidal volume is the basis for assessing lung function and ventilation efficiency, and is an important indicator of lung volume
Measured: 1 year
mean arterial pressure (MAP)
Mean arterial pressure is the average push given by the heart to blood flow throughout the cardiac cycle, with systolic pressure being the peak pressure and diastolic pressure being the pressure nadir.
Measured: 1 year
heart rate (HR)
The normal adult heart rate ranges from 60 to 100 beats per minute, but infants and children have a faster heart rate than adults.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Mar 2024
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yu-Long Jia
- Sponsor type
- University, hospital or other
- Collaborators
- Inner Mongolia Baogang Hospital, The Affiliated Hospital of Inner Mongolia Medical University
- Responsible party
- Sponsor-investigator, Yu-Long Jia, Inner Mongolia University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547411
- Sponsor's protocol ID
- MER-068
- Status last verified
- Aug 2024
- First submitted
- 7 Aug 2024
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Ventilation Modes on Intracranial Pressure and Carbon Dioxide Partial Pressure During Bariatric Surgery: a Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT06547411
- Acronym / sponsor ID
- MER-068
- Conditions
- Ventilation, Bariatric Surgery, Intracranial Pressure, Carbon Dioxide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Yu-Long JiaUniversity, hospital or other
- Collaborators
- Inner Mongolia Baogang Hospital, The Affiliated Hospital of Inner Mongolia Medical University
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 9 Aug 2024 (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 goal of this clinical trial is to explore the clinical significance and value of the PRVC ventilation mode in Bariatric Surgery Patients. The main questions it aims to answer are：
- Do different ventilation patterns affect intracranial pressure and partial pressure of carbon dioxide in bariatric surgery patients?
- Does PRVC mode reduce intracranial pressure and partial pressure of carbon dioxide in bariatric surgery patients?
- Whether intracranial pressure can be quickly measured by monitoring a patient's optic nerve sheath diameter (ONSD)？ Researchers randomized bariatric surgery patients into PC, VC, and PRVC groups for comparison, looking at breathing mechanics, PaCO2, and ICP.
Participants will:
- take PC mode ventilation, VC mode ventilation, and PRVC mode ventilation
- monitor Respiratory mechanics, PaCO2, and ONSD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PC Ventilation mode group | Experimental | Device: PC Ventilation modeGroup I patients received mechanical ventilation using the PC mode. The anesthetic machine (MAQUET Flow-I, Italy) parameters were set as follows: The inspiratory pressure (Pins) was adjusted to maintain an end-tidal carbon dioxide concentration (ETCO2) of 4.0-5.0 kPa. Pure oxygen and air were utilized at 0.3 L/min each, with an oxygen content of 41%. |
| VC Ventilation mode group | Experimental | Device: VC Ventilation modeGroup II patients received mechanical ventilation in VC mode. The tidal volume during regulated breathing was determined based on the ideal body weight (IBW): 6-8 ml/kg (IBW for males: 50 + 0.91 × (height [cm] - 152.4); IBW for females: 45.5 + 0.91 × (height [cm] - 152.4). The positive end-expiratory pressure (PEEP) was set at 10 cmH2O, with an inspiration-to-expiration ratio of 1:2, a respiratory rate of 16 breaths per minute, and an oxygen content of 41% |
| PRVC Ventilation mode group | Experimental | Device: PRVC Ventilation modeGroup III patients received mechanical ventilation using the PRVC mode.The tidal volume during regulated breathing was determined based on the ideal body weight (IBW): 6-8 ml/kg (IBW for males: 50 + 0.91 × (height [cm] - 152.4); IBW for females: 45.5 + 0.91 × (height [cm] - 152.4). The positive end-expiratory pressure (PEEP) was set at 10 cmH2O, with an inspiration-to-expiration ratio of 1:2, a respiratory rate of 16 breaths per minute, and an oxygen content of 41% |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for elective bariatric surgery.
- Age between 16 and 65 years.
- Continuous weight gain for more than 5 years with a BMI ≥ 35.
- ASA-PS (American Society of Anesthesiologists Physical Status) categorization of Grade II or III.
Key exclusion criteria (3 listed)
- Patients who were dependent on alcohol or opioids.
- Patients with severe mental or intellectual disabilities.
- Patients with severe ocular conditions, such as ocular trauma, optic nerve tumors, or those wearing ocular prostheses.
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 |
|---|---|---|
| PC Ventilation modePatients were randomly assigned to three groups using a random number table and the random remainder grouping method at a ratio of 1:1:1. Group I received pressure control ventilation (PC). | Device | PC Ventilation mode group |
| VC Ventilation modePatients were randomly assigned to three groups using a random number table and the random remainder grouping method at a ratio of 1:1:1. Group II received volume control ventilation (VC). | Device | VC Ventilation mode group |
| PRVC Ventilation modePatients were randomly assigned to three groups using a random number table and the random remainder grouping method at a ratio of 1:1:1. Group III received pressure-regulated volume control ventilation (PRVC). | Device | PRVC Ventilation mode group |
Primary outcome
optic nerve sheath diameter [ONSD]
Time frame: 1 year
Patients were positioned supine with their eyes softly closed, and their eyes were protected with disposable transparent patches. A 7.5 MHz linear probe (Micromaxx Ultrasound System; SonoSite Inc., Bothell, WA, USA) was gently placed on the closed upper eyelid without applying pressure to the eyeball, and sufficient ultrasound gel was applied to ensure clear imaging. The optic nerve sheath was checked and measured 3 mm beyond the globe, and three ONSD measures were performed, with the average value utilized as the final ONSD measurement, which was accurate to 0.01 mm.
carbon dioxide partial pressure
Time frame: 1 year
Arterial blood carbon dioxide partial pressure, is an important indicator of alveolar ventilation, reflecting the respiratory factors in acid-base balance. Its reference value is usually 35-45 mmHg.
mean airway pressure (PAWM)
Time frame: 1 year
Mean airway pressure throughout the ventilation cycle
peak airway pressure (PAP)
Time frame: 1 year
Maximum pressure in the airway throughout inspiration
esophageal pressure (PES)
Time frame: 1 year
Esophageal manometry is the recording of pressure changes in various parts of the esophagus at rest and after swallowing, and is used to indicate the motor function of the upper and lower esophageal sphincters and the body of the esophagus, and to understand esophageal motility
tidal volume (TV)
Time frame: 1 year
Tidal volume is the volume of gas inhaled or exhaled each time when breathing calmly, it is an indicator to show lung volume, mainly used for ventilation function test in pulmonary function test. Tidal volume is the basis for assessing lung function and ventilation efficiency, and is an important indicator of lung volume
mean arterial pressure (MAP)
Time frame: 1 year
Mean arterial pressure is the average push given by the heart to blood flow throughout the cardiac cycle, with systolic pressure being the peak pressure and diastolic pressure being the pressure nadir.
heart rate (HR)
Time frame: 1 year
The normal adult heart rate ranges from 60 to 100 beats per minute, but infants and children have a faster heart rate than adults.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PC Ventilation mode, VC Ventilation mode and PRVC Ventilation mode in people with Ventilation and Bariatric Surgery, run by Yu-Long Jia 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 3 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: status not confirmed, as of the sponsor's last update on 5 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Long Jia (14747606821, jiayulong97@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
optic nerve sheath diameter [ONSD] (time frame: 1 year). The study lists 8 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 5 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.