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Ventilator Settings on Patients With Acute Brain Injury

U

University Hospital of North Norway

Status

Completed

Conditions

Acute Brain Injury
Ventilator-Induced Lung Injury
Cerebrovascular Circulation

Treatments

Procedure: Lung protective ventilator settings

Study type

Interventional

Funder types

Other

Identifiers

NCT03278769
Brain-Vent

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

  • • 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 design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

27 participants in 1 patient group

Ventilator setting
Experimental group
Description:
Positive end-expiratory pressure , Tidal volume
Treatment:
Procedure: Lung protective ventilator settings

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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