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

Recruiting

• Conditions: Acute brain injury; Acute respiratory distress syndrome; 10021666

• Registration Number: NL-OMON46412
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

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

- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Mean study endpoint is the change in intracranial pressure at different<br /><br>transpulmonary pressure levels. </p><br>

Secondary Outcome Measures

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