Postoperative Cognitive ImpairmentNCT06764745
Effect of Different Ventilation Modes on POCD in Elderly Patients with Abdominal Wall Hernia
A study testing PC Ventilation Modes, VC Ventilation Modes and PRVC Ventilation Modes in people with Postoperative Cognitive Impairment and Optic Nerve Sheath Edema, run by Inner Mongolia University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Cognitive Impairment, Optic Nerve Sheath Edema
- What is being tested?
- PC Ventilation Modes, VC Ventilation Modes and PRVC Ventilation Modes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 471 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age: 65-90 years
- patients with abdominal wall hernias
- American Society of Anesthesiologists general status (ASA-PS) classes II and III.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Different Ventilation Modes on POCD in Elderly Patients with Abdominal Wall Hernia: a Randomized Controlled Trial
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.
Read more
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
- Being tested
- PC Ventilation Modes, VC Ventilation Modes, PRVC Ventilation Modes
- Keywords
- Ventilation patterns, Elderly patients, Abdominal wall hernia, Postoperative cognitive impairment
- Medical subject headings
- Hernia, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PC Ventilation ModesDevice
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 ModesDevice
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 ModesDevice
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%.
| Study group | Role | What they receive |
|---|---|---|
| PC Ventilation patterns Group | Experimental | Ventilation Modes Following induction, Group I patients received mechanical ventilation using the PC mode. Receives: Device: PC Ventilation Modes |
| VC Ventilation patterns Group | Experimental | Ventilation Modes Following induction, Group II patients received mechanical ventilation using the VC mode. Receives: Device: VC Ventilation Modes |
| PRVC Ventilation patterns Group | Experimental | Ventilation Modes Following induction, Group III patients received mechanical ventilation using the PRVC mode. Receives: Device: PRVC Ventilation Modes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: From induction of anesthesia to the end of surgery
heart rate(HR）
Normal values for heart rate are 60-100 beats per minute.
Measured: From induction of anesthesia to the end of surgery
Secondary outcomes (5)
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.
Measured: From induction of anesthesia to the end of surgery
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.
Measured: From induction of anesthesia to the end of surgery
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.
Measured: From induction of anesthesia to the end of surgery
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.
Measured: From induction of anesthesia to the end of surgery
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.
Measured: From induction of anesthesia to the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start1 Mar 2024
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 471 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inner Mongolia University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Inner Mongolia Baogang Hospital, The Affiliated Hospital of Inner Mongolia Medical University
- Responsible party
- Principal investigator, Yu-Long Jia, Inner Mongolia University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764745
- Sponsor's protocol ID
- MER-076
- Status last verified
- Oct 2024
- First submitted
- 2 Jan 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Ventilation Modes on POCD in Elderly Patients with Abdominal Wall Hernia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06764745
- Acronym / sponsor ID
- MER-076
- Keywords
- Ventilation patterns, Elderly patients, Abdominal wall hernia, Postoperative cognitive impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 471 participants (actual)
- Lead sponsor
- Inner Mongolia University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Inner Mongolia Baogang Hospital, The Affiliated Hospital of Inner Mongolia Medical University
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PC Ventilation patterns Group | Experimental | Device: PC Ventilation ModesVentilation Modes Following induction, Group I patients received mechanical ventilation using the PC mode. |
| VC Ventilation patterns Group | Experimental | Device: VC Ventilation ModesVentilation Modes Following induction, Group II patients received mechanical ventilation using the VC mode. |
| PRVC Ventilation patterns Group | Experimental | Device: PRVC Ventilation ModesVentilation Modes Following induction, Group III patients received mechanical ventilation using the PRVC mode. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age: 65-90 years
- patients with abdominal wall hernias
- American Society of Anesthesiologists general status (ASA-PS) classes II and III.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PC Ventilation ModesFollowing 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%. | Device | PC Ventilation patterns Group |
| VC Ventilation ModesFollowing 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%. | Device | VC Ventilation patterns Group |
| PRVC Ventilation ModesFollowing 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%. | Device | PRVC Ventilation patterns Group |
Primary outcome
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.
5 secondary outcomes
Aβ1-40 (pg·mL-1)
Time frame: From induction of anesthesia to the end of surgery
S100 (pg·mL-1)
Time frame: From induction of anesthesia to the end of surgery
IL-1β (pg·mL-1)
Time frame: From induction of anesthesia to the end of surgery
IL-6 (pg·mL-1)
Time frame: From induction of anesthesia to the end of surgery
TNF-α (pg·mL-1)
Time frame: From induction of anesthesia to the end of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PC Ventilation Modes, VC Ventilation Modes and PRVC Ventilation Modes in people with Postoperative Cognitive Impairment and Optic Nerve Sheath Edema, run by Inner Mongolia University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMSE scale (time frame: From enrollment to two weeks after surgical treatment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.