The Brain and Lung Interaction (BALI) Study
Primary Purpose
Intracranial Pressure, Mechanical Ventilation, Brain Injuries
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PEEP Titrated Mechanical Ventilation
Sponsored by
About this trial
This is an interventional other trial for Intracranial Pressure
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PEEP Titration Arm
Arm Description
Outcomes
Primary Outcome Measures
Change in intracranial pressure
The primary endpoint is the change in intracranial pressure as a function of positive end-expiratory pressure.
Secondary Outcome Measures
Full Information
NCT ID
NCT04288076
First Posted
February 26, 2020
Last Updated
January 25, 2021
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04288076
Brief Title
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
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Low eligibility rate
Study Start Date
September 2020 (Anticipated)
Primary Completion Date
October 15, 2020 (Actual)
Study Completion Date
October 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Pressure, Mechanical Ventilation, Brain Injuries
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PEEP Titration Arm
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
PEEP Titrated Mechanical Ventilation
Intervention Description
Subjects will receive a sequential, step-wise increase in positive end-expired pressure from 5 cmH2O to 15 cmH2O and back down to 5 cmH20. Pleural pressure and intracranial pressure will be measured at each increment. PEEP will be increased by increments of 5 cmH2O. The physiologic measurements will be obtained at regular intervals (within 5 minutes at each PEEP level) throughout the PEEP titration period. The mode of mechanical ventilation (pressure or volume control), inspiratory time and fraction of inspired oxygen (FIO2) will be determined by the critical care team caring for the patient. In the event that PEEP is set > 5 cmH2O, measurements will be obtained from that starting point and increased to a maximum of 15 cmH2O. At the completion of the study patients will be returned to the PEEP level they were on prior to titration of the ventilator.
Primary Outcome Measure Information:
Title
Change in intracranial pressure
Description
The primary endpoint is the change in intracranial pressure as a function of positive end-expiratory pressure.
Time Frame
Change from baseline to 20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22855028
Citation
Rincon F, Ghosh S, Dey S, Maltenfort M, Vibbert M, Urtecho J, McBride W, Moussouttas M, Bell R, Ratliff JK, Jallo J. Impact of acute lung injury and acute respiratory distress syndrome after traumatic brain injury in the United States. Neurosurgery. 2012 Oct;71(4):795-803. doi: 10.1227/NEU.0b013e3182672ae5.
Results Reference
background
PubMed Identifier
10793162
Citation
Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
Results Reference
background
PubMed Identifier
17855672
Citation
Malhotra A. Low-tidal-volume ventilation in the acute respiratory distress syndrome. N Engl J Med. 2007 Sep 13;357(11):1113-20. doi: 10.1056/NEJMct074213.
Results Reference
background
PubMed Identifier
26506991
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.
Results Reference
background
PubMed Identifier
21722336
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.
Results Reference
background
PubMed Identifier
21378554
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.
Results Reference
background
PubMed Identifier
18514826
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.
Results Reference
background
PubMed Identifier
15761353
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.
Results Reference
background
PubMed Identifier
12352486
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.
Results Reference
background
PubMed Identifier
15668765
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.
Results Reference
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The Brain and Lung Interaction (BALI) Study
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