Multicenter Observational Study on Practice of Ventilation in Brain Injured Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Milano Bicocca
- Enrollment
- 2,299
- Locations
- 1
- Primary Endpoint
- Description of different ventilatory strategies applied to acutely brain injured patients admitted to the ICUs
Study Overview
Brief Summary
Rationale Several experimental and clinical studies have shown how brain injury can cause secondary lung injury. Lung injury could be due either to mechanical ventilation- often necessary in brain injured patients- or to inflammatory response that follows primary acute brain injury. The concept of 'Protective lung ventilation' has shown to reduce morbidity and mortality of intensive care unit (ICU) patients with acute respiratory distress syndrome (ARDS) but seems also to have a beneficial effect on patients with healthy lungs and in the perioperative settings. However, these recommendations often come into conflict with the management of patients affected by acute brain injury, in which permissive hypercapnia and increased intrathoracic pressure as consequence of protective ventilation strategies can be dangerous.
Study design This is an international multi-center prospective observational study.
Study population This study will include all consecutive brain injured patients (traumatic brain injury (TBI) or cerebrovascular) intubated and ventilated in ICU and observed for a 7-day period.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness Seen the observational design of the study, there is no patient burden. Collection of data from ICU and hospital charts and/or (electronic) medical records systems is of no risk to patients.
Detailed Description
INTRODUCTION AND RATIONALE Mechanical ventilation (MV) is a frequently applied and often a life-saving strategy in neurocritically ill patients. Paradoxically, ventilation itself has the potential to cause further pulmonary and cerebral damage and can increase mortality and morbidity [1].
The so-called 'protective lung ventilation' strategies include the use of low tidal volume (TV), positive end expiratory pressure (PEEP), and eventually recruitment maneuvers (RMs), and are aimed to prevent lung damage and to reduce morbidity and mortality in patients with acute respiratory distress syndrome (ARDS) [2]. In particular, low tidal volume seems to have the greater importance [3-5], and guidelines strongly recommend its use in critically ill patients with ARDS [6].
Results from one multicenter randomized controlled trial suggest that also ICU patients without ARDS could benefit from 'protective lung ventilation strategies [7]. A recent meta-analysis showed a higher incidence of pulmonary complications and even increased mortality in patients who received 'conventional ventilation' with traditionally sized or higher tidal volumes compared to patients undergoing protective strategies [8].
Present ventilation guidelines for patients with acute brain injury The fourth edition of the Guidelines for the Management of Severe Traumatic Brain Injury [10] suggests maintaining normocapnia in this subset of patients and aiming for peripheral saturation of oxygen higher than 90% to guarantee an adequate cerebral perfusion and avoid secondary brain damages due to hypoxia or inappropriate cerebral vasodilatation [10]. However, BTF guidelines do not provide any advice on ventilator settings or targets. There is still uncertainty regarding the use of protective ventilation in neurologically ill patients. Brain injured patients have been traditionally excluded from the major trials regarding mechanical ventilation and the use of lung protective ventilator strategies because low tidal volumes, high PEEP and RMs can increase carbon dioxide levels (CO2) and increase intrathoracic pressure, thus having detrimental effects on intracranial pressure (ICP) and cerebral perfusion pressure (CPP).
METHODS
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients admitted to the ICU with a diagnosis of
- •traumatic brain injury or
- •cerebrovascular diseases (intracranial hemorrhage, subarachnoid hemorrhage, ischemic stroke)
- •Patients requiring intubation and mechanical ventilation in the ICU
- •Expected ventilation for more than 48 hours
Exclusion Criteria
- •Age < 18 years
- •Pregnant patients
- •Patients not intubated or not mechanically ventilated or receiving only non-invasive ventilation (i.e., the patient never received invasive ventilation during the present admission)
- •Patients under invasive mechanical ventilation before the 7-day period of inclusion
- •Expected ventilation or death< 48 hours
Outcomes
Primary Outcomes
Description of different ventilatory strategies applied to acutely brain injured patients admitted to the ICUs
Time Frame: 12 months
We will compare the different ventilatory approaches to intubated and mechanically ventilated neurocritically ill patients admitted to worldwide ICUs.
Secondary Outcomes
- Description of mechanical ventilation-associated complication(12 months)
- Correlation between ventilatory targets and neurological outcome at ICU discharge and after 6 months from admission(12 months)
- Description of different ventolatory approaches to nuerocritically-ill patients(12 months)
- Correlation between ventilatory targets and neurological secondary injury(12 months)