Evaluating automated ventilation for brain injury patients
Effectiveness, Safety and Efficacy of Closed-Loop Ventilation in Acute Brain Injury-Patients
This study is testing if a new automated breathing machine can help patients with severe brain injuries breathe better and recover more effectively.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 105 Years |
| Sex | All |
| Sponsor | University of Genova Academic / other |
| Locations | 1 site (Genova, GE) |
| Trial ID | NCT06367816 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effectiveness, efficacy, and safety of the closed-loop ventilation mode INTELLiVENT-ASV in patients with acute brain injury who require invasive ventilation. The study will collect breath-by-breath data before and after switching to INTELLiVENT-ASV, allowing for a detailed analysis of its impact on both brain and lung protection. The decision to switch ventilators will be made by the attending healthcare worker based on clinical needs, and data will be gathered over a limited time frame. The goal is to determine if this advanced ventilation method can improve patient outcomes in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are intubated and receiving invasive ventilation for acute brain injury in an Intensive Care Unit.
Not a fit: Patients who are on ventilators that do not support INTELLiVENT-ASV will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the safety and effectiveness of ventilation in patients with acute brain injuries.
How similar studies have performed: While closed-loop ventilation has shown effectiveness in other critically ill patient populations, this specific application in acute brain injury patients is novel and has not been thoroughly tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * aged ≥ 18 years; * intubated and receiving invasive ventilation for ABI; * admitted to the Intensive Care Unit Exclusion Criteria: - receiving ventilation with a ventilator that does not allow INTELLiVENT-ASV
Where this trial is running
Genova, GE
- UO Clinica Anestesiologica e Terapia Intensiva, IRCCS Ospedale Policlinico San Martino — Genova, Ge, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.