Effect of Different Ventilation Modes on POCD in Elderly Patients with Abdominal Wall Hernia: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 471
- Locations
- 1
- Primary Endpoint
- MMSE scale
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to 90 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age: 65-90 years
- •patients with abdominal wall hernias
- •American Society of Anesthesiologists general status (ASA-PS) classes II and III.
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
MMSE scale
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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）
Time Frame: 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）
Time Frame: From induction of anesthesia to the end of surgery
Normal values for heart rate are 60-100 beats per minute.
Secondary Outcomes
- 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)
Investigators
Yu-Long Jia
Principal Investigator
Inner Mongolia University of Science and Technology