Effects of Different Ventilation Modes on Intracranial Pressure and Carbon Dioxide Partial Pressure During Bariatric Surgery: a Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- heart rate (HR)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for elective bariatric surgery.
- •Age between 16 and 65 years.
- •Continuous weight gain for more than 5 years with a BMI ≥
- •ASA-PS (American Society of Anesthesiologists Physical Status) categorization of Grade II or III.
排除标准
- •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.
结局指标
主要结局
heart rate (HR)
时间窗: 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)
时间窗: 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]
时间窗: 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)
时间窗: 1 year
Maximum pressure in the airway throughout inspiration
esophageal pressure (PES)
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 1 year
Mean airway pressure throughout the ventilation cycle
次要结局
未报告次要终点
研究者
Yu-Long Jia
Principal Investigator
Inner Mongolia University of Science and Technology