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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Withdrawn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

About this trial

This is an interventional other trial for Intracranial Pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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

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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

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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

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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

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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

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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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