ClinicalTrials.gg
CompletedNCT03278769Updated May 23, 2022

Ventilator Settings on Patients With Acute Brain Injury

An interventional study of Lung protective ventilator settings in Acute Brain Injury, Ventilator-Induced Lung Injury and Cerebrovascular Circulation, sponsored by University Hospital of North Norway. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-23.

Sponsored by University Hospital of North Norway · Not applicable, Interventional, and Basic science

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 20 studies in Brain Injuries with a site in Norway — 2 open to participants now, 2 under way, none of them phase 3. Brain Injuries · Norway.

Enrollment
11th of 18
27 · median 45
Started
2019
the only one that year
No phase
18 of 20
2 open now
Registered
7th of 20
by date
Lead sponsor
2 of 20
University Hospital of North Norway

Among the 20 studies in Brain Injuries with a site in Norway, this one is the 11th largest by enrollment of the 18 interventional ones that give a count, is the only one that started in 2019, is one of 18 with no phase, and was the 7th registered.

Brain Injuries

947 studies on the registry are indexed under Brain Injuries; 236 are open to participants now.

Browse Brain Injuries studies →

Open to participants now

2 of the 20 studies in Brain Injuries with a site in Norway are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in Norway have not opened yet or have stopped. Only those recruiting at a site in Norway →

Who these studies take

Of the 152 Brain Injuries studies recruiting now, 75 (49%) set no upper age limit and 55 (36%) stop at 75 or younger; 39 take children under 18; 23 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 20 studies in Brain Injuries with a site in Norway, or all of them as a file.
02

Study 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 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.

  1. increase intracranial pressure
  2. 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.

03

Conditions studied

  • Acute Brain Injury
  • Ventilator-Induced Lung Injury
  • Cerebrovascular Circulation
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    • Any tracheally intubated or tracheotomized adult patient with ABI with GCS\< 9 on controlled ventilation requiring continuous ICP measurement.
  • Proxy from relatives.

Exclusion criteria

Exclusion Criteria:

    • 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.
  • (BMI) > 35.
  • Known right or biventricular cardiac failure with cardiac index \< 2,5 L/min/m2 or ejection fracture \< 40 %.
  • 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    Ventilator setting

    Positive end-expiratory pressure , Tidal volume

    Procedure: Lung protective ventilator settings

Interventions

  • ProcedureLung protective ventilator settings

    Positive end-expiratory pressure 12, Tidal volume 6 milliliter/kilogram predicted body weight

06

What researchers measure

Primary outcomes

  1. Intracranial pressure

    intracranial pressure increase with lung protective setting

    Time frame: 120 minutes

  2. pressure reactivity index

    Diminished pressure reactivity index

    Time frame: 120 minutes

07

Study locations

1 site
  • University Hospital North Norway
    Tromsø, Troms 9010, Norway
08

References and documents

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 19388307 ↗
  • Koutsoukou 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 26855895 ↗
  • Mauri 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 27334266 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2019 to primary completion in Sep 2021, 27 months.

Of 284 non-industry interventional studies with no phase under Brain Injuries, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 50. This study's 27 months is close to that.

Counting every sponsor, half of 297 studies reached it within 24 months; a quarter within 12 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 29, 2017
First posted
Sep 12, 2017
StartActual
Jun 1, 2019
Primary completionActual
Sep 1, 2021
CompletionActual
Jan 1, 2022
Last update
May 23, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03278769
Collaborators
Cambridge University Hospitals NHS Foundation Trust, Hôpital de la Croix-Rousse
Responsible party
Shirin Kordasti Frisvold (Principal investigator, PhD, University Hospital of North Norway) — Principal investigator
First posted
Sep 12, 2017
Start date
Jun 1, 2019
Primary completion
Sep 1, 2021
Completion
Jan 1, 2022
Last update
May 23, 2022

Study contacts

Shirin K Frisvold
principal investigator · University Hospital of North Norway

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion