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Completed

NCT Number: NCT06367816

Brain Recovery With Automated VEntilation

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.

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Key information

Conditions

Brain Injuries, Acute Automation Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiration, Artificial Respiratory Aspiration Respiratory Tract Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–105 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UO Clinica Anestesiologica e Terapia Intensiva, IRCCS Ospedale Policlinico San Martino

Genova, GE, 16132, Italy

About this study

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, i.e., not protocolized and only for clinical/organizational 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

INTELLiVENT

Procedure

Closed-loop mode of ventilation

conventional ventilation

Procedure

Mode of ventilation

Primary outcomes

  1. Proportion of breaths in predefined zones of ventilation

    Time frame: 7 hours from baseline

  2. Proportion of time in predefined zones of ventilation

    Time frame: 7 hours from baseline

Secondary outcomes

  1. Intracerebral changes assessed by multimodal neuromonitoring available

    Time frame: 7 hours from baseline

  2. Changes on Electrical Impedence Tomography when available

    Time frame: 7 hours from baseline

  3. Effectiveness in primary ABI patients vs non primary ABI patients

    Time frame: 7 hours from baseline

  4. Episodes and time of high maximum airway pressure

    Time frame: 7 hours from baseline

  5. Episodes and time of high respiratory rate

    Time frame: 7 hours from baseline

  6. Incidence of severe hypoxemia

    Time frame: 7 hours from baseline

  7. Incidence of severe hypercapnia

    Time frame: 7 hours from baseline

  8. Discontinuation of ventilatory mode (yes or no)

    Time frame: 7 hours from baseline

  9. Percentage of breaths in the predefined 'critical' ventilation zone

    Time frame: 7 hours from baseline

  10. Incidence of pneumothorax

    Time frame: 8 hours from baseline

  11. Efficacy on glascow coma scale

    Time frame: 7 hours from baseline

  12. Duration of ventilation in survivors

    Time frame: 90 days

  13. Ventilator free days

    Time frame: 90 days

  14. Intensive care unit length of stay

    Time frame: 90 days

  15. Hospital length of stay

    Time frame: 90 days

  16. 28-day mortality

    Time frame: 90 days

  17. 90-day mortality

    Time frame: 90 days

  18. Number of alarms

    Time frame: 7 hours from baseline

  19. Number of manual adjustments

    Time frame: 7 hours from baseline

Sponsors and collaborators

Lead sponsor

University of Genova

Other

Registry information

Official study title

Effectiveness, Safety and Efficacy of Closed-Loop Ventilation in Acute Brain Injury-Patients

Acronym: BRAVE

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 16, 2024
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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