Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06367816
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-11
Brief Title:
Brain Recovery With Automated VEntilation
Sponsor:
University of Genova
Organization:
University of Genova
Study Overview
Official Title:
Effectiveness Safety and Efficacy of Closed-Loop Ventilation in Acute Brain Injury-Patients
Status:
RECRUITING
Status Verified Date:
2024-04
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:
BRAVE
Brief Summary:
Thus far the closed-loop ventilation mode INTELLiVENT-ASV has been extensively tested in various groups of critically ill patients and has been shown to be effective and safe in various groups of ventilated patients including those at risk of acute respiratory distress syndrome ARDS patients with ARDS and patients with chronic obstructive pulmonary disease COPD Some of these studies included acute brain injury ABI patients but the effectiveness efficacy and safety of INTELLiVENT-ASV has never been thoroughly tested in these patients The current study will investigate the effectiveness in providing both brain- and lung protective ventilation the safety and the efficacy of a closed-loop ventilation mode INTELLiVENT-ASV in acute brain injury patients using breath-by-breath data
Detailed Description:
Rationale Closed-loop ventilation has been proven effective in lung-protective ventilation but its effectiveness safety and efficacy in providing both lung- and brain-protective ventilation in patients with acute brain injury has not been investigated
Objective To evaluate the effectiveness efficacy and safety of INTELLiVENT-ASV with respect to brain- and lung-protective ventilation in ABI patients
Hypothesis We hypothesize that INTELLiVENT-ASV is effective with regard to brain- and lung-protective ventilation that is achieving brain- and lung- protective targets efficacious that is improving outcomes and that INTELLiVENT-ASV is safe in invasively ventilated ABI patients
Study design Single-center crossover trial
Methods In this prospective observational study breath-by-breath ventilation data will be available from before and after the switch to closed-loop ventilation with INTELLiVENT-ASV wherein the decision to switch is determined by the attending healthcare worker ie not protocolized and only for clinicalorganizational reasons High granular data are collected both before and after this switch limited to three hours for conventional and three hours for closed-loop ventilation Neuromonitoring is part of current clinical practice and data will be collected only when available
Study population Invasively ventilated patients diagnosed with acute brain injury Methods When the ventilator is switched upon the caregivers decision data will be collected from three hours before the switch and three hours after the switch
Study endpoints The primary composite endpoint is the proportion of breaths and proportion of time within predefined zones of ventilation based on VT and airway pressures saturation of peripheral O2 SpO2 and end-tidal CO2 EtCO2
Objective To evaluate the effectiveness efficacy and safety of INTELLiVENT-ASV with respect to brain- and lung-protective ventilation in ABI patients
Hypothesis We hypothesize that INTELLiVENT-ASV is effective with regard to brain- and lung-protective ventilation that is achieving brain- and lung- protective targets efficacious that is improving outcomes and that INTELLiVENT-ASV is safe in invasively ventilated ABI patients
Study design Single-center crossover trial
Methods In this prospective observational study breath-by-breath ventilation data will be available from before and after the switch to closed-loop ventilation with INTELLiVENT-ASV wherein the decision to switch is determined by the attending healthcare worker ie not protocolized and only for clinicalorganizational reasons High granular data are collected both before and after this switch limited to three hours for conventional and three hours for closed-loop ventilation Neuromonitoring is part of current clinical practice and data will be collected only when available
Study population Invasively ventilated patients diagnosed with acute brain injury Methods When the ventilator is switched upon the caregivers decision data will be collected from three hours before the switch and three hours after the switch
Study endpoints The primary composite endpoint is the proportion of breaths and proportion of time within predefined zones of ventilation based on VT and airway pressures saturation of peripheral O2 SpO2 and end-tidal CO2 EtCO2
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