Clinical trial NCT04288076: The Brain and Lung Interaction (BALI) Study
Official title: The Effect of Positive End Expiratory Pressure on Intracranial Pressure: The Brain and Lung Interaction (BALI) Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Intracranial Pressure
Mechanical Ventilation
Brain Injuries
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to understand the relationship between intracranial pressure and airway pressures during mechanical ventilation. This study is a single-center, prospective cohort study to be conducted at Beth Israel Deaconess Medical Center. The investigators will recruit patients with severe brain injury (GCS 8 or less) who receive intracranial pressure monitoring and mechanical ventilation as part of their routine medical care. The primary endpoint is the change in intracranial pressure as a function of positive end-expiratory pressure. There is only one study encounter with safety monitoring for up to 24 hours after. No additional follow up is required.


Eligibility criteria: Inclusion Criteria:

- Patients with severe brain injury (GCS 8 or less) who receive both mechanical ventilation and intracranial pressure monitoring as part of their standard medical care will be considered eligible.

Exclusion Criteria:

* Patients with esophageal varices
* Patients with esophageal trauma
* Patients with recent esophageal surgery
* Patients with coagulopathy (Platelets \< 80k or INR\> 2 )
* Other contraindication for esophageal manometry
* Patients who are receiving PEEP greater than 15 cmH2O within 24 hours prior to enrollment
* Intracranial hypertension (defined as ICP greater than 20 mmHg) within 48 hours prior to enrollment
* Decompressive hemi-craniectomy

Cessation Criteria: Study related ventilator adjustments and measurements will be stopped at any point during the intervention and ventilator settings will be returned to the pre-intervention settings under the following conditions:

* If ICP increases above 20mmHg, regardless of the duration of the event.
* If systolic blood pressure decreases below 90mmHg, regardless of the duration of the event.
* If systolic blood pressure increases above 180mmHg, regardless of the duration of the event.

Primary outcomes:
measure: Change in intracranial pressure
timeFrame: Change from baseline to 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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citation: Quilez ME, Fuster G, Villar J, Flores C, Marti-Sistac O, Blanch L, Lopez-Aguilar J. Erratum to: Injurious mechanical ventilation affects neuronal activation in ventilated rats. Crit Care. 2015 Oct 27;19:379. doi: 10.1186/s13054-015-1076-5. No abstract available.
citation: Pelosi P, Rocco PR. The lung and the brain: a dangerous cross-talk. Crit Care. 2011;15(3):168. doi: 10.1186/cc10259. Epub 2011 Jun 30.
citation: Pelosi P, Ferguson ND, Frutos-Vivar F, Anzueto A, Putensen C, Raymondos K, Apezteguia C, Desmery P, Hurtado J, Abroug F, Elizalde J, Tomicic V, Cakar N, Gonzalez M, Arabi Y, Moreno R, Esteban A; Ventila Study Group. Management and outcome of mechanically ventilated neurologic patients. Crit Care Med. 2011 Jun;39(6):1482-92. doi: 10.1097/CCM.0b013e31821209a8.
citation: Stevens RD, Lazaridis C, Chalela JA. The role of mechanical ventilation in acute brain injury. Neurol Clin. 2008 May;26(2):543-63, x. doi: 10.1016/j.ncl.2008.03.014.
citation: Caricato A, Conti G, Della Corte F, Mancino A, Santilli F, Sandroni C, Proietti R, Antonelli M. Effects of PEEP on the intracranial system of patients with head injury and subarachnoid hemorrhage: the role of respiratory system compliance. J Trauma. 2005 Mar;58(3):571-6. doi: 10.1097/01.ta.0000152806.19198.db.
citation: Huynh T, Messer M, Sing RF, Miles W, Jacobs DG, Thomason MH. Positive end-expiratory pressure alters intracranial and cerebral perfusion pressure in severe traumatic brain injury. J Trauma. 2002 Sep;53(3):488-92; discussion 492-3. doi: 10.1097/00005373-200209000-00016.
citation: Mascia L, Grasso S, Fiore T, Bruno F, Berardino M, Ducati A. Cerebro-pulmonary interactions during the application of low levels of positive end-expiratory pressure. Intensive Care Med. 2005 Mar;31(3):373-9. doi: 10.1007/s00134-004-2491-2. Epub 2005 Jan 25.