Acute Brain InjuryNCT03278769
Ventilator Settings on Patients With Acute Brain Injury
A study testing Lung protective ventilator settings in people with Acute Brain Injury and Ventilator-Induced Lung Injury, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
The present study is an explorative analysis of the relationship between cerebral blood perfusion and oxygenation and lung mechanical variables at different ventilator settings. It is a safety study excluding patients with severe lung injury or brain edema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Brain Injury, Ventilator-Induced Lung Injury, Cerebrovascular Circulation
- What is being tested?
- Lung protective ventilator settings
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jun 2019to 1 Jan 2022
- 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
- • Any tracheally intubated or tracheotomized adult patient with ABI with GCS< 9 on controlled ventilation requiring continuous ICP measurement.
- Proxy informed consent from relatives.
Who cannot join
- • ICP > 22 mmHg before treatment of high ICP
- Acute respiratory failure defined as partial pressure of oxygen/ inspiratory oxygen fraction (PaO2/FiO2) ratio < 40 kPa and Xray pathology
- History of pulmonary disese: Chronic respiratory failure diagnosis stage III and IV in the GOLD classification, pulmectomy, lobectomy or restrictive lung disease.
- Body mass index (BMI) > 35.
- Known right or biventricular cardiac failure with cardiac index < 2,5 L/min/m2 or ejection fracture < 40 %.
- Refractory hypovolemia as diagnosed with pulse pressure variation > 12 % with tidal volume 8 ml/predicted bodyweight (intubated on controlled ventilation) or passive leg rise test with > 10 % increase in stroke volume measured by VTI echocardiography or PICCO.
- Medulla lesion that affect the autonomic nervous system.
- Patients who has undergone decompressive craniectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relation Between Lung Protective Mechanical Ventilation, Intracranial Pressure, Autoregulation and Brain Oxygenation in Neurointensive Care Patients
The present study is an explorative analysis of the relationship between cerebral blood perfusion and oxygenation and lung mechanical variables at different ventilator settings. It is a safety study excluding patients with severe lung injury or brain edema.
Read the detailed description
The primary goal is to carry out baseline measurements to enable conclusions concerning the safety of lung protective ventilator settings before extending the study to patients with more severe brain and/or lung injury in the future.
The primary objective is to investigate if lung protective ventilator settings (higher Positive end-expiratory pressure and lower tidal volume) as compared with conventional settings.
- increase intracranial pressure
- diminish cerebral vasoreactive autoregulation as assessed by pressure reactivity index, ie pressure reactivity index will turn positive, which means that it will change the state from intact to impaired autoregulation.
The secondary objective is an exploratory analysis of the relationship between ventilator settings and other well defined respiratory, cerebral, and cardiovascular variables, including transpulmonary pressure.
- Being tested
- Lung protective ventilator settings
- Medical subject headings
- Brain Injuries, Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung protective ventilator settingsProcedure or surgery
Positive end-expiratory pressure 12, Tidal volume 6 milliliter/kilogram predicted body weight
| Study group | Role | What they receive |
|---|---|---|
| Ventilator setting | Experimental | Positive end-expiratory pressure , Tidal volume Receives: Procedure: Lung protective ventilator settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial pressure
intracranial pressure increase with lung protective setting
Measured: 120 minutes
pressure reactivity index
Diminished pressure reactivity index
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start1 Jun 2019
- Primary completion1 Sep 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Brain InjuryStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust, Hôpital de la Croix-Rousse
- Responsible party
- Principal investigator, Shirin Kordasti Frisvold, University Hospital of North Norway
- Investigators
- Shirin K Frisvold, Principal investigator, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278769
- Sponsor's protocol ID
- Brain-Vent
- Status last verified
- May 2022
- First submitted
- 29 Aug 2017
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smielewski P, Lavinio A, Timofeev I, Radolovich D, Perkes I, Pickard JD, Czosnyka M. ICM+, a flexible platform for investigations of cerebrospinal dynamics in clinical practice. Acta Neurochir Suppl. 2008;102:145-51. doi: 10.1007/978-3-211-85578-2_30.
PubMed 19388307Koutsoukou A, Katsiari M, Orfanos SE, Kotanidou A, Daganou M, Kyriakopoulou M, Koulouris NG, Rovina N. Respiratory mechanics in brain injury: A review. World J Crit Care Med. 2016 Feb 4;5(1):65-73. doi: 10.5492/wjccm.v5.i1.65. eCollection 2016 Feb 4.
PubMed 26855895Mauri T, Yoshida T, Bellani G, Goligher EC, Carteaux G, Rittayamai N, Mojoli F, Chiumello D, Piquilloud L, Grasso S, Jubran A, Laghi F, Magder S, Pesenti A, Loring S, Gattinoni L, Talmor D, Blanch L, Amato M, Chen L, Brochard L, Mancebo J; PLeUral pressure working Group (PLUG-Acute Respiratory Failure section of the European Society of Intensive Care Medicine). Esophageal and transpulmonary pressure in the clinical setting: meaning, usefulness and perspectives. Intensive Care Med. 2016 Sep;42(9):1360-73. doi: 10.1007/s00134-016-4400-x. Epub 2016 Jun 22.
PubMed 27334266Beqiri E, Smielewski P, Guerin C, Czosnyka M, Robba C, Bjertnaes L, Frisvold SK. Neurological and respiratory effects of lung protective ventilation in acute brain injury patients without lung injury: brain vent, a single centre randomized interventional study. Crit Care. 2023 Mar 20;27(1):115. doi: 10.1186/s13054-023-04383-z.
PubMed 36941683
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Lung Protective Mechanical Ventilation, Intracranial Pressure, Autoregulation and Brain Oxygenation in Neurointensive Care Patients
- ClinicalTrials.gov ID
- NCT03278769
- Acronym / sponsor ID
- Brain-Vent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust, Hôpital de la Croix-Rousse
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 12 Sep 2017 (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 present study is an explorative analysis of the relationship between cerebral blood perfusion and oxygenation and lung mechanical variables at different ventilator settings. It is a safety study excluding patients with severe lung injury or brain edema.
Detailed description
The primary goal is to carry out baseline measurements to enable conclusions concerning the safety of lung protective ventilator settings before extending the study to patients with more severe brain and/or lung injury in the future.
The primary objective is to investigate if lung protective ventilator settings (higher Positive end-expiratory pressure and lower tidal volume) as compared with conventional settings.
- increase intracranial pressure
- diminish cerebral vasoreactive autoregulation as assessed by pressure reactivity index, ie pressure reactivity index will turn positive, which means that it will change the state from intact to impaired autoregulation.
The secondary objective is an exploratory analysis of the relationship between ventilator settings and other well defined respiratory, cerebral, and cardiovascular variables, including transpulmonary pressure.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ventilator setting | Experimental | Procedure: Lung protective ventilator settingsPositive end-expiratory pressure , Tidal volume |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- • Any tracheally intubated or tracheotomized adult patient with ABI with GCS< 9 on controlled ventilation requiring continuous ICP measurement.
- Proxy informed consent from relatives.
Key exclusion criteria (8 listed)
- • ICP > 22 mmHg before treatment of high ICP
- Acute respiratory failure defined as partial pressure of oxygen/ inspiratory oxygen fraction (PaO2/FiO2) ratio < 40 kPa and Xray pathology
- History of pulmonary disese: Chronic respiratory failure diagnosis stage III and IV in the GOLD classification, pulmectomy, lobectomy or restrictive lung disease.
- Body mass index (BMI) > 35.
- Known right or biventricular cardiac failure with cardiac index < 2,5 L/min/m2 or ejection fracture < 40 %.
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 |
|---|---|---|
| Lung protective ventilator settingsPositive end-expiratory pressure 12, Tidal volume 6 milliliter/kilogram predicted body weight | Procedure or surgery | Ventilator setting |
Primary outcome
Intracranial pressure
Time frame: 120 minutes
intracranial pressure increase with lung protective setting
pressure reactivity index
Time frame: 120 minutes
Diminished pressure reactivity index
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Background: PubMed 19388307Smielewski P, Lavinio A, Timofeev I, Radolovich D, Perkes I, Pickard JD, Czosnyka M. ICM+, a flexible platform for investigations of cerebrospinal dynamics in clinical practice. Acta Neurochir Suppl. 2008;102:145-51. doi: 10.1007/978-3-211-85578-2_30.
- Background: PubMed 26855895Koutsoukou A, Katsiari M, Orfanos SE, Kotanidou A, Daganou M, Kyriakopoulou M, Koulouris NG, Rovina N. Respiratory mechanics in brain injury: A review. World J Crit Care Med. 2016 Feb 4;5(1):65-73. doi: 10.5492/wjccm.v5.i1.65. eCollection 2016 Feb 4.
- Background: PubMed 27334266Mauri T, Yoshida T, Bellani G, Goligher EC, Carteaux G, Rittayamai N, Mojoli F, Chiumello D, Piquilloud L, Grasso S, Jubran A, Laghi F, Magder S, Pesenti A, Loring S, Gattinoni L, Talmor D, Blanch L, Amato M, Chen L, Brochard L, Mancebo J; PLeUral pressure working Group (PLUG-Acute Respiratory Failure section of the European Society of Intensive Care Medicine). Esophageal and transpulmonary pressure in the clinical setting: meaning, usefulness and perspectives. Intensive Care Med. 2016 Sep;42(9):1360-73. doi: 10.1007/s00134-016-4400-x. Epub 2016 Jun 22.
- Derived from this study: PubMed 36941683Beqiri E, Smielewski P, Guerin C, Czosnyka M, Robba C, Bjertnaes L, Frisvold SK. Neurological and respiratory effects of lung protective ventilation in acute brain injury patients without lung injury: brain vent, a single centre randomized interventional study. Crit Care. 2023 Mar 20;27(1):115. doi: 10.1186/s13054-023-04383-z.
- 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.
Shirin K Frisvold principal investigator
University Hospital of North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung protective ventilator settings in people with Acute Brain Injury and Ventilator-Induced Lung Injury, run by University Hospital of North Norway at 1 site in Norway.
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 2 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: finished, as of the sponsor's last update on 23 May 2022. 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 Norway. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intracranial pressure (time frame: 120 minutes). The study lists 2 primary outcomes in all. 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 NCT03278769, which also lists 4 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 23 May 2022.