Effect of Different Ventilation Modes on POCD in Elderly Patients with Abdominal Wall Hernia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 471
- 试验地点
- 1
- 主要终点
- MMSE scale
研究概览
简要总结
The purpose of this clinical trial is to understand the effect of different ventilation patterns during surgery on postoperative cognitive impairment in elderly patients with abdominal wall hernias. It will also explore how to reduce the incidence of postoperative cognitive impairment. The main questions it aims to answer are:
- Does the mode of ventilation affect the incidence of postoperative cognitive impairment in elderly patients?
- Does optic nerve sheath edema affect the incidence of postoperative cognitive impairment in elderly patients? Researchers will monitor patients with different ventilation patterns intraoperatively and investigate postoperatively to see if the ventilation pattern affects postoperative cognitive impairment.
Participants will:
- Randomly assigned to groups with different ventilation patterns
- Record various values during surgery by the researchers
- Presence of cognitive impairment assessed by cognitive scales after surgery
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 65-90 years
- •patients with abdominal wall hernias
- •American Society of Anesthesiologists general status (ASA-PS) classes II and III.
排除标准
- •Emergency (rather than elective) surgery or other types of surgery required
- •More than one surgery required during hospitalization
- •Preoperative demonstrated inability to communicate (due to coma, severe dementia, Parkinson's disease, severe hearing or visual impairment, or speech impairment).
结局指标
主要结局
MMSE scale
时间窗: From enrollment to two weeks after surgical treatment
Range Score \<21 Increased odds of dementia Score \>25 Decreased odds of dementia Education Score \< 21 Abnormal for 8" grade Score \<23 Abnormal for high school education Score \<24 Abnormal for college education Severity 24-30 No cognitive impairment 18-23 Mild cognitive impairment 0-17 Severe cognitive impairment
optic nerve sheath diameter (ONSD)
时间窗: From induction of anesthesia to the end of surgery
The ONSD was assessed using ocular ultrasonography to non-invasively capture ICP. Bedside ultrasound measurements of the ONSD were performed by an experienced and professionally qualified ultrasound physician. 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.
average airway pressure( PAWM)
时间窗: From induction of anesthesia to the end of surgery
Mean airway pressure affects the patient's alveolar oxygenation status and blood circulation. Mean airway pressure is most affected by positive end-expiratory pressure, followed by prolongation of inspiratory time, which can also increase mean airway pressure.
esophagealp ressure（PES)
时间窗: From induction of anesthesia to the end of surgery
Esophageal pressure monitoring is a minimally invasive and clinically available method for estimating transpulmonary pressure, of which absolute values and changes are considered one of the main determinants of lung injury due to mechanical forces applied during mechanical ventilation . PES was monitored using a floating catheter (Swan-Ganz, USA) placed into the esophagus and coupled to a monitor (M8003A, Germany).
PaCO2(mmHg)
时间窗: From induction of anesthesia to the end of surgery
Arterial reference value: 35-45 mmHg, exceeding or falling below the reference value is called hyper- or hypocapnia. Exceeding 55mmHg may inhibit the respiratory center. It is the main index to determine the acid-base poisoning of each type.
mean arterial pressure（MAP）
时间窗: From induction of anesthesia to the end of surgery
Above 60 mmHg is sufficient to provide organ sustenance in the general population.calculated as MAP = diastolic pressure + 1/3 pulse pressure difference.
heart rate(HR）
时间窗: From induction of anesthesia to the end of surgery
Normal values for heart rate are 60-100 beats per minute.
次要结局
- Aβ1-40 (pg·mL-1)(From induction of anesthesia to the end of surgery)
- S100 (pg·mL-1)(From induction of anesthesia to the end of surgery)
- IL-1β (pg·mL-1)(From induction of anesthesia to the end of surgery)
- IL-6 (pg·mL-1)(From induction of anesthesia to the end of surgery)
- TNF-α (pg·mL-1)(From induction of anesthesia to the end of surgery)
研究者
Yu-Long Jia
Principal Investigator
Inner Mongolia University of Science and Technology