Ignite Creation Date:
2024-07-17 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480162
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-04-27
Brief Title:
Mechanical Ventilation on Hippocampus
Sponsor:
Beijing Sanbo Brain Hospital
Organization:
Beijing Sanbo Brain Hospital
Study Overview
Official Title:
Impact of Mechanical Ventilation on Hippocampal Oscillation and Respiratory-hippocampus Coupling
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None