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CompletedNCT06764745Updated Mar 5, 2025

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

An interventional study of PC Ventilation Modes and VC Ventilation Modes in Postoperative Cognitive Impairment and Optic Nerve Sheath Edema, sponsored by Inner Mongolia University of Science and Technology. Completed at 1 site in China. Open to participants aged 65 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-05.

Sponsored by Inner Mongolia University of Science and Technology · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Feb 2025, 1 year 8 months ago, and no results have been posted to the registry.
  • Registered 10 months after the study started (first participant enrolled Mar 2024, registered Jan 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
471
Allocation
Randomized
Ages
65 Years to 90 Years
Sex
All
01

Study 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
02

Conditions studied

  • Postoperative Cognitive Impairment
  • Optic Nerve Sheath Edema

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Keywords

  • Ventilation patterns
  • Elderly patients
  • Abdominal wall hernia
  • Postoperative cognitive impairment
03

In context

Hernia, Abdominal

82 studies on the registry are indexed under Hernia, Abdominal; 19 are open to participants now.

This study's enrollment of 471 is above the median of 90 across 48 interventional studies indexed under Hernia, Abdominal.

Browse Hernia, Abdominal studies →

Lead sponsor

This is the only study on the registry with Inner Mongolia University of Science and Technology as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
471 participants (actual)

Study arms

  • Experimental
    PC Ventilation patterns Group

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

    Device: PC Ventilation Modes

  • Experimental
    VC Ventilation patterns Group

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

    Device: VC Ventilation Modes

  • Experimental
    PRVC Ventilation patterns Group

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

    Device: PRVC Ventilation Modes

Interventions

  • DevicePC Ventilation Modes

    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%.

  • DeviceVC Ventilation Modes

    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%.

  • DevicePRVC Ventilation Modes

    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%.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: From enrollment to two weeks after surgical treatment

  2. 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.

    Time frame: From induction of anesthesia to the end of surgery

  3. 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.

    Time frame: From induction of anesthesia to the end of surgery

  4. 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).

    Time frame: From induction of anesthesia to the end of surgery

  5. 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.

    Time frame: From induction of anesthesia to the end of surgery

  6. 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.

    Time frame: From induction of anesthesia to the end of surgery

  7. heart rate(HR)

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

    Time frame: From induction of anesthesia to the end of surgery

Secondary outcomes

  1. Aβ1-40 (pg·mL-1)

    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.

    Time frame: From induction of anesthesia to the end of surgery

  2. S100 (pg·mL-1)

    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.

    Time frame: From induction of anesthesia to the end of surgery

  3. IL-1β (pg·mL-1)

    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.

    Time frame: From induction of anesthesia to the end of surgery

  4. IL-6 (pg·mL-1)

    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.

    Time frame: From induction of anesthesia to the end of surgery

  5. TNF-α (pg·mL-1)

    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.

    Time frame: From induction of anesthesia to the end of surgery

07

Study locations

1 site
  • Inner Mongolia Baosteel Hospital
    Baotou, Inner Mongolia 014010, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06764745
Lead sponsor
Inner Mongolia University of Science and Technology
Collaborators
Inner Mongolia Baogang Hospital, The Affiliated Hospital of Inner Mongolia Medical University
Responsible party
Yu-Long Jia (Principal Investigator, Inner Mongolia University of Science and Technology) — Principal investigator
First posted
Jan 8, 2025
Start date
Mar 1, 2024
Primary completion
Feb 28, 2025
Completion
Feb 28, 2025
Last update
Mar 5, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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