Mechanical Ventilation on Hippocampus

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Injuries; Mechanical Ventilation Complication
• Intervention / Treatment: Procedure: Mechanical ventilation

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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Zhonghua Shi, PhD,MD; Phone Number: 010-62856764; Email: z.shi@mail.ccmu.edu.cn
• Study Contact Backup: Name: Xiang Qi; Phone Number: 010-62856764; Email: 13643112610@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100090
      • Recruiting
      • Beijing Sanbo Brain Hospital, Capital Medical University
      • Contact: Zhonghua Shi, PhD, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• Age: ≥ 18 years
• ASA: I - II
• w/ electrode inside hippocampus (≥ 1 contacts)
• Singed consent form

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	During the process of weaning off mechanical ventilation, assessed up to 3 hours.

Collaborators and Investigators

• Sponsor: Beijing Sanbo Brain Hospital
• Investigators: Principal Investigator: Zhonghua Shi, PhD,MD, Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: April 27, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): June 28, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Mechanical Ventilation; Ventilator Associated Brain Injury; Hippocampus Oscillation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: VABI-Hipp

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No