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

NCT06764745 | Completed FDA Device

• 1 other identifier: MER-076
• Study Type: interventional
• Target: 471
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Cognitive Impairment; Optic Nerve Sheath Edema

Keywords

Ventilation patterns; Elderly patients; Abdominal wall hernia; Postoperative cognitive impairment

Outcome Measures

Primary Outcomes (7)

• MMSE scale

  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

  From enrollment to two weeks after surgical treatment

• optic nerve sheath diameter (ONSD)

  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.

  From induction of anesthesia to the end of surgery

• average airway pressure( PAWM)

  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.

  From induction of anesthesia to the end of surgery

• esophagealp ressure（PES)

  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).

  From induction of anesthesia to the end of surgery

• PaCO2(mmHg)

  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.

  From induction of anesthesia to the end of surgery

• mean arterial pressure（MAP）

  Above 60 mmHg is sufficient to provide organ sustenance in the general population.calculated as MAP = diastolic pressure + 1/3 pulse pressure difference.

  From induction of anesthesia to the end of surgery

• heart rate(HR）

  Normal values for heart rate are 60-100 beats per minute.

  From induction of anesthesia to the end of surgery

Secondary Outcomes (5)

• 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

Study Arms (3)

PC Ventilation patterns Group

EXPERIMENTAL

Ventilation Modes Following induction, Group I patients received mechanical ventilation using the PC mode.

Device: PC Ventilation Modes

VC Ventilation patterns Group

EXPERIMENTAL

Ventilation Modes Following induction, Group II patients received mechanical ventilation using the VC mode.

Device: VC Ventilation Modes

PRVC Ventilation patterns Group

EXPERIMENTAL

Ventilation Modes Following induction, Group III patients received mechanical ventilation using the PRVC mode.

Device: PRVC Ventilation Modes

Interventions

PC Ventilation Modes DEVICE

Following induction, 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%. 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%.

PC Ventilation patterns Group

VC Ventilation Modes DEVICE

Following induction, Group II patients received mechanical ventilation using the VC 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%. 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%.

VC Ventilation patterns Group

PRVC Ventilation Modes DEVICE

Following induction, Group III patients received mechanical ventilation using the PRVC 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%. 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 patterns Group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age: 65-90 years
• patients with abdominal wall hernias
• American Society of Anesthesiologists general status (ASA-PS) classes II and III.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Inner Mongolia University of Science and Technology: lead
• Inner Mongolia Baogang Hospital: collaborator
• The Affiliated Hospital of Inner Mongolia Medical University: collaborator

Study Sites (1)

Inner Mongolia Baosteel Hospital

Baotou, Inner Mongolia, 014010, China

Location

MeSH Terms

Conditions

Hernia, Abdominal

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 8, 2025
• Study Start: March 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: March 5, 2025

Record last verified: 2024-10

Locations

CN (1)