Mechanical Ventilation ComplicationNCT06480162
Mechanical Ventilation on Hippocampus
An observational study of Mechanical Ventilation Complication and Brain Injuries, run by Beijing Sanbo Brain Hospital at 1 site in China.
Trial summary
Ventilator-associated brain injury (VABI) frequently occurs in ICU patients. Although animal studies indicate the hippocampus as a key target of VABI, its relevance in human patients remains uncertain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication, Brain Injuries
- What is being tested?
- Mechanical ventilation
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2024to 1 Jun 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with drug-resistant epilepsy and scheduled for sterero-electroencephalograophy (sEEG) exploration as part of pre-surgical assessment will be screened for eligibility.
Who may be able to join
- Age: ≥ 18 years
- ASA: I - II
- w/ electrode inside hippocampus (≥ 1 contacts)
- Singed consent form
Who cannot join
- Seizure occurrence ≤ 36 hours before op.
- Structural brain damage
- History of using: opioids, enzyme-inducing medications, sleep aids, or excessive alcohol consumption
- History of mechanical ventilation (>24h)
- Cognitive impairment
- Operation within 6 months
- Participate in other clinical trials in the last four weeks
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Sanbo Brain Hospital, Capital Medical University
Beijing, Beijing Municipality, 100090
Zhonghua Shi, PhD, MD
About this study
Official title: Impact of Mechanical Ventilation on Hippocampal Oscillation and Respiratory-hippocampus Coupling
Ventilator-associated brain injury (VABI) frequently occurs in ICU patients. Although animal studies indicate the hippocampus as a key target of VABI, its relevance in human patients remains uncertain. In this study, the investigators aim to monitor hippocampal EEG activity during the weaning process of patients off mechanical ventilation, and also exploring the coupling between breathing patterns and hippocampal activity.
Read the detailed description
[Rational] Although mechanical ventilation (MV) is crucial for saving lives, the high incidence of ventilator-associated brain injury (VABI) in ICU patients, affecting up to 80% of cases, raises significant clinical concerns. VABI not only increases mortality and morbidity rates but also strains healthcare resources. Despite abundant evidence from preclinical studies, the precise impact of mechanical ventilation on humans remains largely unknown. Understanding these effects is crucial for uncovering the mechanisms behind VABI and subsequently preventing and treating this complication.
[Methods] Patients with drug-resistant epilepsy scheduled for stereoelectroencephalography (sEEG) exploration as part of their pre-surgical assessment will undergo eligibility screening. During the study, sEEG signals and respiratory data will be simultaneously collected from the hippocampus and other relevant limbic structures under various mechanical ventilation scenarios. These scenarios include controlled ventilation at different levels of positive end-expiratory pressure (PEEP, 5cmH2O vs. 10cmH2O) and respiratory rates (RR, 10 vs. 20 bpm), assisted ventilation, and natural breathing phases. Following the discontinuation of mechanical ventilation, patients will be monitored for up to 7 days to evaluate the occurrence of delirium. Additionally, simultaneous intracranial EEG recordings from relevant cortical and subcortical regions will be conducted.
[Aims] The current study aims to investigate the effects of mechanical ventilation, including variations in RR and PEEP, on neurophysiological electrical oscillations within the hippocampus, as well as the relationship between breathing patterns and hippocampal activity. Furthermore, the investigators will explore the impact of mechanical ventilation on other cortical areas involved in breathing, depending on electrode positioning, and examine the interactions between these brain regions and the hippocampus.
- Being tested
- Mechanical ventilation
- Keywords
- Ventilator Associated Brain Injury, Hippocampus Oscillation, Mechanical Ventilation
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ventilationProcedure or surgery
After replacing the electrode, we'll monitor the EEG activity of the hippocampus and other cortex regions while weaning off mechanical ventilation.
What is being measured
The primary outcome is the main question the study is designed to answer.
intracranial EEG (iEEG) recording of the hippocampus
The iEEG data from each patient will be analyzed using Python (version 3.12.4). The data will be represented as power spectral density, also known as the power spectrum or spectrum, which measures the frequency distribution of energy or power within a signal. The power spectrum for each channel will be computed using the Fast Fourier Transform (FFT).
Measured: During the process of weaning off mechanical ventilation, assessed up to 3 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start8 May 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilation ComplicationStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Sanbo Brain Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhonghua Shi, MD, PhD, Beijing Sanbo Brain Hospital
- Investigators
- Zhonghua Shi, PhD,MD, Principal investigator, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480162
- Sponsor's protocol ID
- VABI-Hipp
- Status last verified
- Jun 2024
- First submitted
- 27 Apr 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qi X, Ou X, Li J, Zhang M, Xue F, Wei H, Su W, Wang J, Sun Y, Zhou J, Wang B, Shi Z. Mechanical Ventilation-Associated Changes in Hippocampal Electroencephalogram: A Cross-Species Study in Humans and Rats. CNS Neurosci Ther. 2026 Jul;32(7):e71012. doi: 10.1002/cns.71012.
PubMed 42454700
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mechanical Ventilation on Hippocampal Oscillation and Respiratory-hippocampus Coupling
- ClinicalTrials.gov ID
- NCT06480162
- Acronym / sponsor ID
- VABI-Hipp
- Keywords
- Ventilator Associated Brain Injury, Hippocampus Oscillation, Mechanical Ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beijing Sanbo Brain HospitalUniversity, hospital or other
- Study start
- 8 May 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 28 Jun 2024 (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.
Ventilator-associated brain injury (VABI) frequently occurs in ICU patients. Although animal studies indicate the hippocampus as a key target of VABI, its relevance in human patients remains uncertain. In this study, the investigators aim to monitor hippocampal EEG activity during the weaning process of patients off mechanical ventilation, and also exploring the coupling between breathing patterns and hippocampal activity.
Detailed description
[Rational] Although mechanical ventilation (MV) is crucial for saving lives, the high incidence of ventilator-associated brain injury (VABI) in ICU patients, affecting up to 80% of cases, raises significant clinical concerns. VABI not only increases mortality and morbidity rates but also strains healthcare resources. Despite abundant evidence from preclinical studies, the precise impact of mechanical ventilation on humans remains largely unknown. Understanding these effects is crucial for uncovering the mechanisms behind VABI and subsequently preventing and treating this complication.
[Methods] Patients with drug-resistant epilepsy scheduled for stereoelectroencephalography (sEEG) exploration as part of their pre-surgical assessment will undergo eligibility screening. During the study, sEEG signals and respiratory data will be simultaneously collected from the hippocampus and other relevant limbic structures under various mechanical ventilation scenarios. These scenarios include controlled ventilation at different levels of positive end-expiratory pressure (PEEP, 5cmH2O vs. 10cmH2O) and respiratory rates (RR, 10 vs. 20 bpm), assisted ventilation, and natural breathing phases. Following the discontinuation of mechanical ventilation, patients will be monitored for up to 7 days to evaluate the occurrence of delirium. Additionally, simultaneous intracranial EEG recordings from relevant cortical and subcortical regions will be conducted.
[Aims] The current study aims to investigate the effects of mechanical ventilation, including variations in RR and PEEP, on neurophysiological electrical oscillations within the hippocampus, as well as the relationship between breathing patterns and hippocampal activity. Furthermore, the investigators will explore the impact of mechanical ventilation on other cortical areas involved in breathing, depending on electrode positioning, and examine the interactions between these brain regions and the hippocampus.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with drug-resistant epilepsy and scheduled for sterero-electroencephalograophy (sEEG) exploration as part of pre-surgical assessment will be screened for eligibility.
Key inclusion criteria (4 listed)
- Age: ≥ 18 years
- ASA: I - II
- w/ electrode inside hippocampus (≥ 1 contacts)
- Singed consent form
Key exclusion criteria (8 listed)
- Seizure occurrence ≤ 36 hours before op.
- Structural brain damage
- History of using: opioids, enzyme-inducing medications, sleep aids, or excessive alcohol consumption
- History of mechanical ventilation (>24h)
- Cognitive 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 |
|---|---|---|
| Mechanical ventilationAfter replacing the electrode, we'll monitor the EEG activity of the hippocampus and other cortex regions while weaning off mechanical ventilation. | Procedure or surgery | – |
Primary outcome
intracranial EEG (iEEG) recording of the hippocampus
Time frame: During the process of weaning off mechanical ventilation, assessed up to 3 hours.
The iEEG data from each patient will be analyzed using Python (version 3.12.4). The data will be represented as power spectral density, also known as the power spectrum or spectrum, which measures the frequency distribution of energy or power within a signal. The power spectrum for each channel will be computed using the Fast Fourier Transform (FFT).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Derived from this study: PubMed 42454700Qi X, Ou X, Li J, Zhang M, Xue F, Wei H, Su W, Wang J, Sun Y, Zhou J, Wang B, Shi Z. Mechanical Ventilation-Associated Changes in Hippocampal Electroencephalogram: A Cross-Species Study in Humans and Rats. CNS Neurosci Ther. 2026 Jul;32(7):e71012. doi: 10.1002/cns.71012.
- Individual participant dataSharing planned: No
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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.
Zhonghua Shi, PhD,MD principal investigator
Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation Complication and Brain Injuries, run by Beijing Sanbo Brain Hospital 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 9 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhonghua Shi, PhD,MD (010-62856764, z.shi@mail.ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intracranial EEG (iEEG) recording of the hippocampus (time frame: During the process of weaning off mechanical ventilation, assessed up to 3 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06480162, which also lists 1 linked publication.
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 9 Aug 2024.