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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

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

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.

02

Conditions studied

  • Acute Brain Injury
  • Ventilator-Induced Lung Injury
  • Cerebrovascular Circulation
03

Who can participate

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

Inclusion criteria

    • Any tracheally intubated or tracheotomized adult patient with ABI with GCS\< 9 on controlled ventilation requiring continuous ICP measurement.
  • Proxy informed consent 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.
  • 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.
04

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

05

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

06

Study locations

1 site
  • University Hospital North Norway
    Tromsø, Troms 9010, Norway
07

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

  • Protocol and statistical analysis plan · May 1, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03278769
Lead sponsor
University Hospital of North Norway
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 ↗

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