Effects of Different Anesthesia Machine Modalities on Bariatric Surgery Patients: a Prospective Randomized Controlled Study
- Conditions
- Carbon DioxideVentilationBariatric SurgeryIntracranial Pressure
- Interventions
- Device: PC Ventilation modeDevice: VC Ventilation modeDevice: PRVC Ventilation mode
- Registration Number
- NCT06547411
- Lead Sponsor
- Yu-Long Jia
- Brief 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?
* 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PC Ventilation mode group PC Ventilation mode 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%. VC Ventilation mode group VC Ventilation mode 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% PRVC Ventilation mode group PRVC Ventilation mode 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%
- Primary Outcome Measures
Name Time Method heart rate (HR) 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.
tidal volume (TV) 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
optic nerve sheath diameter [ONSD] 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.
peak airway pressure (PAP) 1 year Maximum pressure in the airway throughout inspiration
esophageal pressure (PES) 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
mean arterial pressure (MAP) 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.
carbon dioxide partial pressure 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) 1 year Mean airway pressure throughout the ventilation cycle
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Inner Mongolia Baogang Hospital
🇨🇳Baotou, Inner Mongolia, China