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Completed

NCT Number: NCT06764745

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

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

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Key information

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inner Mongolia Baosteel Hospital

Baotou, Inner Mongolia, 014010, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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%.

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%.

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%.

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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.

  7. 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

  1. Aβ1-40 (pg·mL-1)

    Time frame: 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.

  2. S100 (pg·mL-1)

    Time frame: 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.

  3. IL-1β (pg·mL-1)

    Time frame: 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.

  4. IL-6 (pg·mL-1)

    Time frame: 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.

  5. TNF-α (pg·mL-1)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Inner Mongolia University of Science and Technology

Other

Collaborators

  • Inner Mongolia Baogang Hospital
  • The Affiliated Hospital of Inner Mongolia Medical University

Registry information

Official study title

Effect of Different Ventilation Modes on POCD in Elderly Patients with Abdominal Wall Hernia: a Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 8, 2025
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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