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Completed

NCT Number: NCT03278769

Ventilator Settings on Patients With Acute Brain Injury

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital North Norway

Tromsø, Troms, 9010, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lung protective ventilator settings

Procedure

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

Primary outcomes

  1. Intracranial pressure

    Time frame: 120 minutes

    intracranial pressure increase with lung protective setting

  2. pressure reactivity index

    Time frame: 120 minutes

    Diminished pressure reactivity index

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Collaborators

  • Cambridge University Hospitals NHS Foundation Trust
  • Hôpital de la Croix-Rousse

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Sep 12, 2017
Registry last updated
May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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