Effect of Different Ventilation Modes on POCD in Elderly Patients with Abdominal Wall Hernia

Not Applicable

Completed

• Conditions: Postoperative Cognitive Impairment; Optic Nerve Sheath Edema

• Registration Number: NCT06764745
• Lead Sponsor: Inner Mongolia University of Science and Technology

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Status Verified: 2024-10
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-02
• Study First Posted: 2025-01-08
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 471

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
MMSE scale	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)	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)	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)	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)	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）	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）	From induction of anesthesia to the end of surgery	Normal values for heart rate are 60-100 beats per minute.

Secondary Outcome Measures

Name	Time	Method
Aβ1-40 (pg·mL-1)	From induction of anesthesia to the end of surgery	In the morning, 10 mL of venous blood from the upper limbs was withdrawn under fasting conditions, put into polypropylene EDTA anticoagulation tubes, centrifuged at 1 000 r/min for 3 min within 60 min (maximal centrifugal force: 27 700×g), and plasma was extracted, frozen in a refrigerator at -20 ℃, and then left to be measured. Plasma Aβ1-40 and inflammatory indexes were detected by enzyme-linked immunosorbent assay in the two groups.
S100 (pg·mL-1)	From induction of anesthesia to the end of surgery	In the morning, 10 mL of venous blood from the upper limbs was withdrawn under fasting conditions, put into polypropylene EDTA anticoagulation tubes, centrifuged at 1 000 r/min for 3 min within 60 min (maximal centrifugal force: 27 700×g), and plasma was extracted, frozen in a refrigerator at -20 ℃, and then left to be measured. Plasma Aβ1-40 and inflammatory indexes were detected by enzyme-linked immunosorbent assay in the two groups.
IL-1β (pg·mL-1)	From induction of anesthesia to the end of surgery	In the morning, 10 mL of venous blood from the upper limbs was withdrawn under fasting conditions, put into polypropylene EDTA anticoagulation tubes, centrifuged at 1 000 r/min for 3 min within 60 min (maximal centrifugal force: 27 700×g), and plasma was extracted, frozen in a refrigerator at -20 ℃, and then left to be measured. Plasma Aβ1-40 and inflammatory indexes were detected by enzyme-linked immunosorbent assay in the two groups.
IL-6 (pg·mL-1)	From induction of anesthesia to the end of surgery	In the morning, 10 mL of venous blood from the upper limbs was withdrawn under fasting conditions, put into polypropylene EDTA anticoagulation tubes, centrifuged at 1 000 r/min for 3 min within 60 min (maximal centrifugal force: 27 700×g), and plasma was extracted, frozen in a refrigerator at -20 ℃, and then left to be measured. Plasma Aβ1-40 and inflammatory indexes were detected by enzyme-linked immunosorbent assay in the two groups.
TNF-α (pg·mL-1)	From induction of anesthesia to the end of surgery	In the morning, 10 mL of venous blood from the upper limbs was withdrawn under fasting conditions, put into polypropylene EDTA anticoagulation tubes, centrifuged at 1 000 r/min for 3 min within 60 min (maximal centrifugal force: 27 700×g), and plasma was extracted, frozen in a refrigerator at -20 ℃, and then left to be measured. Plasma Aβ1-40 and inflammatory indexes were detected by enzyme-linked immunosorbent assay in the two groups.

Trial Locations

Locations (1)

Inner Mongolia Baosteel Hospital; 🇨🇳 Baotou, Inner Mongolia, China