Ventilator Settings on Patients With Acute Brain Injury

Not Applicable

Completed

• Conditions: Ventilator-Induced Lung Injury; Acute Brain Injury; Cerebrovascular Circulation
• Interventions: Procedure: Lung protective ventilator settings

• Registration Number: NCT03278769
• Lead Sponsor: University Hospital of North Norway

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.

Study Timeline

• Study First Submitted: 2017-08-29
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-12
• Study Start: 2019-06-01
• Primary Completion: 2021-09-01
• Study Completion: 2022-01-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ventilator setting	Lung protective ventilator settings	Positive end-expiratory pressure , Tidal volume

Primary Outcome Measures

Name	Time	Method
Intracranial pressure	120 minutes	intracranial pressure increase with lung protective setting
pressure reactivity index	120 minutes	Diminished pressure reactivity index

Trial Locations

Locations (1)

University Hospital North Norway; 🇳🇴 Tromsø, Troms, Norway