Intracranial PressureNCT04288076
The Brain and Lung Interaction (BALI) Study
A study testing PEEP Titrated Mechanical Ventilation in people with Intracranial Pressure and Mechanical Ventilation, run by Beth Israel Deaconess Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Pressure, Mechanical Ventilation, Brain Injuries
- What is being tested?
- PEEP Titrated Mechanical Ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2020to 15 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
About this study
Official title: The Effect of Positive End Expiratory Pressure on Intracranial Pressure: The Brain and Lung Interaction (BALI) Study
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.
- Being tested
- PEEP Titrated Mechanical Ventilation
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP Titrated Mechanical VentilationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PEEP Titration Arm | Experimental | Not described Receives: Other: PEEP Titrated Mechanical Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intracranial pressure
The primary endpoint is the change in intracranial pressure as a function of positive end-expiratory pressure.
Measured: Change from baseline to 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study startSep 2020 (estimated)
- Primary completion15 Oct 2020
- Study completion15 Oct 2020
Why it stopped: Low eligibility rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Intracranial PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahzad Shaefi, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288076
- Sponsor's protocol ID
- 2019P000830
- Status last verified
- Jan 2021
- First submitted
- 26 Feb 2020
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22855028Acute 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.
PubMed 10793162Malhotra 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.
PubMed 17855672Quilez 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.
PubMed 26506991Pelosi 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.
PubMed 21722336Pelosi 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.
PubMed 21378554Stevens 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.
PubMed 18514826Caricato 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.
PubMed 15761353Huynh 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.
PubMed 12352486Mascia 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.
PubMed 15668765
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Positive End Expiratory Pressure on Intracranial Pressure: The Brain and Lung Interaction (BALI) Study
- ClinicalTrials.gov ID
- NCT04288076
- Acronym / sponsor ID
- 2019P000830
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Low eligibility rate
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEEP Titration Arm | Experimental | Other: PEEP Titrated Mechanical Ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEEP Titrated Mechanical VentilationSubjects 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. | Other | PEEP Titration Arm |
Primary outcome
Change in intracranial pressure
Time frame: Change from baseline to 20 minutes
The primary endpoint is the change in intracranial pressure as a function of positive end-expiratory pressure.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Background: PubMed 22855028Rincon 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.
- Background: PubMed 10793162Acute 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.
- Background: PubMed 17855672Malhotra 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.
- Background: PubMed 26506991Quilez 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.
- Background: PubMed 21722336Pelosi 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.
- Background: PubMed 21378554Pelosi 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.
- Background: PubMed 18514826Stevens 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.
- Background: PubMed 15761353Caricato 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.
- Background: PubMed 12352486Huynh 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.
- Background: PubMed 15668765Mascia 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP Titrated Mechanical Ventilation in people with Intracranial Pressure and Mechanical Ventilation, run by Beth Israel Deaconess Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intracranial pressure (time frame: Change from baseline to 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04288076, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.