Mechanical Ventilation on Hippocampus

NCT06480162 | Recruiting

• 1 other identifier: VABI-Hipp
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation Complication; Brain Injuries

Keywords

Ventilator Associated Brain Injury; Hippocampus Oscillation; Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

Mechanical ventilation PROCEDURE

After replacing the electrode, we'll monitor the EEG activity of the hippocampus and other cortex regions while weaning off mechanical ventilation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Sanbo Brain Hospital: lead

Study Sites (1)

Beijing Sanbo Brain Hospital, Capital Medical University

Beijing, Beijing Municipality, 100090, China

RECRUITING

MeSH Terms

Conditions

Brain Injuries

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Officials

• Zhonghua Shi, PhD,MD

  Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhonghua Shi, PhD,MD

CONTACT

010-62856764; z.shi@mail.ccmu.edu.cn

Xiang Qi

CONTACT

010-62856764; 13643112610@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy president of the department ICU

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: June 28, 2024
• Study Start: May 8, 2024
• Primary Completion: April 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)