Intracranial HypertensionNCT02680704
Mechanical Ventilation in Severe Brain Injury: The Effect of Positive End Expiratory Pressure on Intracranial Pressure
A study testing PEEP titrated mechanical ventilation in people with Intracranial Hypertension and Critical Illness, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to collect physiologic data from patients with severe brain injury who require mechanical ventilation in order to describe the impact of ventilation, specifically positive end expiratory pressure (PEEP), on intracranial pressure (ICP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Hypertension, Critical Illness, Brain Injuries
- What is being tested?
- PEEP titrated mechanical ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 2 Aug 2018
- 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)
- Receiving mechanical ventilation
- Receiving intracranial pressure monitoring
Who cannot join
- Esophageal varices
- Esophageal trauma
- Recent esophageal surgery
- Coagulopathy (Platelets < 80k or INR> 2 )
- Other contraindication for esophageal manometry
- Already receiving PEEP > 15 cmH2O at enrollment
- Intracranial hypertension (defined as ICP > 20 mmHg)
- Decompressive hemi-craniectomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
The purpose of this study is to collect physiologic data from patients with severe brain injury who require mechanical ventilation in order to describe the impact of ventilation, specifically positive end expiratory pressure (PEEP), on intracranial pressure (ICP).
- Conditions
- Intracranial Hypertension, Critical Illness, Brain Injuries, Lung Injury, Respiratory Failure, Positive-Pressure Respiration, Intrinsic
- Being tested
- PEEP titrated mechanical ventilation
- Medical subject headings
- Intracranial Hypertension, Critical Illness, Brain Injuries, Lung Injury, Respiratory Insufficiency, Positive-Pressure Respiration, Intrinsic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP titrated mechanical ventilationOther
Enrolled patients will receive a sequential, step-wise increase in positive end-expired pressure from 5 cmH2O to 15 cmH2O. Intracranial pressure, transpulmonary pressure, vitals, and mechanical ventilator data will be measured at each increment. PEEP will be increased by increments of 5 cmH2O. 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. The physiologic measurements will be obtained at regular intervals (within 5 minutes at each PEEP level) throughout the PEEP titration period.
| Study group | Role | What they receive |
|---|---|---|
| PEEP Titration Arm | Other | PEEP titrated mechanical ventilation Receives: Other: PEEP titrated mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between PEEP and ICP
Intracranial pressure will be measured and recorded using the existing intracranial pressure monitoring device placed previously as part of the patient's routine care. The association between positive end expiratory pressure and intracranial pressure will be analyzed as the primary outcome.
Measured: Change from baseline to 20 minutes
Secondary outcomes (2)
Association between transpulmonary pressure and ICP
Transpulmonary pressure will be measured and recorded using an esophageal balloon catheter placed for research purposes. The association between transpulmonary pressure change with titration of PEEP and intracranial pressure will be analyzed as a secondary outcome.
Measured: Change from baseline to 20 minutes
Association between PEEP and cerebral hemodynamics
Cerebral hemodynamic information will be recorded and calculated. The association between positive end expiratory pressure and cerebral hemodynamics will be analyzed as a secondary outcome.
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 posted11 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion2 Aug 2018
- Study completion2 Aug 2018
Why it stopped: Departure of PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial HypertensionStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valerie Banner-Goodspeed, Beth Israel Deaconess Medical Center
- Investigators
- M. Dustin Boone, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680704
- Sponsor's protocol ID
- 2015P000089
- Status last verified
- Feb 2019
- First submitted
- 9 Feb 2016
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Ventilation in Severe Brain Injury: The Effect of Positive End Expiratory Pressure on Intracranial Pressure
- ClinicalTrials.gov ID
- NCT02680704
- Acronym / sponsor ID
- 2015P000089
- Conditions
- Intracranial Hypertension, Critical Illness, Brain Injuries, Lung Injury, Respiratory Failure, Positive-Pressure Respiration, Intrinsic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Departure of PI
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- 2 Aug 2018 (actual)
- Study completion
- 2 Aug 2018 (actual)
- First posted
- 11 Feb 2016 (estimated)
- 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 collect physiologic data from patients with severe brain injury who require mechanical ventilation in order to describe the impact of ventilation, specifically positive end expiratory pressure (PEEP), on intracranial pressure (ICP).
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 | Other | Other: PEEP titrated mechanical ventilationPEEP 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 (3 listed)
- Patients with severe brain injury (GCS 8 or less)
- Receiving mechanical ventilation
- Receiving intracranial pressure monitoring
Key exclusion criteria (8 listed)
- Esophageal varices
- Esophageal trauma
- Recent esophageal surgery
- 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 ventilationEnrolled patients will receive a sequential, step-wise increase in positive end-expired pressure from 5 cmH2O to 15 cmH2O. Intracranial pressure, transpulmonary pressure, vitals, and mechanical ventilator data will be measured at each increment. PEEP will be increased by increments of 5 cmH2O. 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. The physiologic measurements will be obtained at regular intervals (within 5 minutes at each PEEP level) throughout the PEEP titration period. | Other | PEEP Titration Arm |
Primary outcome
Association between PEEP and ICP
Time frame: Change from baseline to 20 minutes
Intracranial pressure will be measured and recorded using the existing intracranial pressure monitoring device placed previously as part of the patient's routine care. The association between positive end expiratory pressure and intracranial pressure will be analyzed as the primary outcome.
2 secondary outcomes
Association between transpulmonary pressure and ICP
Time frame: Change from baseline to 20 minutes
Association between PEEP and cerebral hemodynamics
Time frame: Change from baseline to 20 minutes
Results and safety
The study was stopped early (reason given: Departure of PI). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- 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.
M. Dustin Boone, MD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP titrated mechanical ventilation in people with Intracranial Hypertension and Critical Illness, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: Departure of PI). Results are not available in the source record.
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?
Association between PEEP and ICP (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?
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 22 Feb 2019.