Ventilator Settings on Patients With Acute Brain Injury

Relation Between Lung Protective Mechanical Ventilation, Intracranial Pressure, Autoregulation and Brain Oxygenation in Neurointensive Care Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03278769

Enrollment

Registered

2017-09-12

Start date

2019-06-01

Completion date

2022-01-01

Last updated

2022-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Brain Injury, Cerebrovascular Circulation, Ventilator-Induced Lung Injury

Brief 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.

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.

Interventions

PROCEDURELung protective ventilator settings

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Intracranial pressure	120 minutes	intracranial pressure increase with lung protective setting
pressure reactivity index	120 minutes	Diminished pressure reactivity index

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026