Effect of positive transpulmonary pressures on intracranial pressure and cerebrovascular autoregulation in severe acute brain injury

Effect of positive transpulmonary pressures on intracranial pressure and cerebrovascular autoregulation in severe acute brain injury - Effect intrathoracic pressures on intracranial pressures

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46412

Enrollment

Registered

2018-06-04

Start date

2021-04-21

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute brain injury Acute respiratory distress syndrome

Interventions

PEEP levels will be titrated to such a level that transpulmonary pressure during end-expiratory occlusion will be at 0, 5 and 10 cmH2O. Titration of PEEP is part of standard critical care, the inter

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age * 18 years Severe TBI defined as Glasgow Coma Score 3-8 Multimodal neuromonitoring, including at least intracranial pressure monitoring Acute respiratory distress syndrome (ARDS, according to the Berlin definition)

Exclusion criteria

Exclusion criteria: - Hemodynamic instability, despite fluid resuscitation and/or vasopressor use. - Pneumothorax in last 3 days before the start of the study - Signs and/or symptoms of brain herniation based on clinical symptoms and or CT cerebrum - Pregnancy - Status after decompressive craniectomy - During or after Penthotal coma - Unfavourable ventilator settings before start of the study (defined as plateau pressures > 30 cm H2O, or FiO2 > 60%) - Intracranial pressure > 20 mmHg for at least 5 minutes, despite the use of ICP lowering treatment - Moribund (fixed pupils or signs of brainstem coning) - History of oesophageal surgery

Design outcomes

Primary

Measure	Time frame
Mean study endpoint is the change in intracranial pressure at different transpulmonary pressure levels.	—

Secondary

Measure	Time frame
Secondary endpoints include - Changes in MFVMCA at different transpulmonary pressure levels - Cerebral oxygenation changes at different transpulmonary pressure levels - Hemodynamic changes at different transpulmonary pressure levels - Changes in oxygenation and ventilation parameters - Respiratory system compliance changes at different transpulmonary pressure levels, - Effects of changes in transpulmonary pressure on these different parameters will be compared between patients with normal and disturbed cerebral autoregulation,and between patients with a good and exhausted cerebral compensatory reserve.	—

Measure

Time frame

Secondary endpoints include - Changes in MFVMCA at different transpulmonary pressure levels - Cerebral oxygenation changes at different transpulmonary pressure levels - Hemodynamic changes at different transpulmonary pressure levels - Changes in oxygenation and ventilation parameters - Respiratory system compliance changes at different transpulmonary pressure levels, - Effects of changes in transpulmonary pressure on these different parameters will be compared between patients with normal and disturbed cerebral autoregulation,and between patients with a good and exhausted cerebral compensatory reserve.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)