Continuous Regional Analysis Device for Neonate Lung

Study Overview
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Brief Summary
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The purpose of the study is to assess whether Electrical Impedance Tomography (EIT) has the potential to optimize the ventilator therapy, validate the effectiveness, efficacy and safety of nursing and medical interventions (endotracheal suctioning, posture changes, surfactant therapy, recruitment manoeuvres, etc.) and for early recognition of complications like pneumothorax and endotracheal tube misplacement. The study design is purely observational.

Detailed Description
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EIT data will be recorded during 72 hours of routine clinical treatment. To prevent any decisions based on EIT information, the clinicians will be blinded to the EIT findings during the study period. Data on clinical interventions and clinical findings will be recorded using a specially adapted graphical user interface on the EIT device in combination with a paper-based case report form (CRF). EIT data analysis will be performed off-line.

Official Title
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Continuous Regional Analysis Device for Neonate Lung

Conditions
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Infant Respiratory Distress Syndrome, Acute Bronchiolitis, Acute Respiratory Distress Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written, informed consent of both parents or legal representative Admission in the NICU or PICU Patients with or at high risk of developing respiratory failure needing respiratory support. o i.e. (oxygen need (FiO2>25%) AND noninvasive or invasive respiratory support) AND/OR repeated apnea with desaturations Age from birth to 7 years o Initial focus will be on neonates up to 6 kg and 12 months age. Infants of higher weight up to 7 years age will be included as EIT belts for this age group become available. Exclusion Criteria: Post menstrual age less than 25 weeks Body weight < 600 g Electrically active implants Thorax skin lesions Prior participation for the same diagnosis of lung disease

Ages Eligible for Study
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Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in aggregate measure of ventilation homogeneity (coefficient of variation and global inhomogeneity index of regional tidal volume) by > 10% compared with baseline |  | 72 hours | 
| Change in right-to-left and/or anteroposterior ventilation distribution by >10% compared with baseline |  | 72 hours | 
| Time and duration of right-to-left or left-to-right ventilation ratio >2:1 |  | 72 hours | 
| Percentage of EIT examination time with at least 26 out of 32 sensors exhibiting skin contact impedance of < 700 Ohm | Skin contact impedance will be monitored continuously by the EIT device. If more than 6 sensors exhibit skin contact impedance > 700 Ohm, the examination is no longer suitable for analyzing. To assess the percentage of EIT measurements suitable for analyzing, we will calculate the percentage of EIT examination time with at least 26 out of 32 sensors exhibiting skin contact impedance of less than 700 Ohm. | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between time of onset/end of non-invasive respiratory support and EIT findings |  | 72 hours | 
| Relationship between time of intubation/extubation and EIT findings |  | 72 hours | 
| Relationship between time of suctioning and EIT findings |  | 72 hours | 
| Relationship between time and type of posture change and EIT findings |  | 72 hours | 
| Relationship between time of surfactant administration and EIT findings |  | 72 hours | 
| Relationship between time of clinically indicated radiological examination and EIT findings |  | 72 hours | 
| Relationship between time of recruitment manoeuvre and EIT findings |  | 72 hours | 
| Relationship between time of confirmed pneumothorax and EIT findings |  | 72 hours | 
| Relationship between time of confirmed endotracheal tube malposition and EIT findings |  | 72 hours | 
| Relationship between primary cause of respiratory failure and EIT findings |  | 72 hours | 
| Relationship between fraction of inspired oxygen over time and EIT findings |  | 72 hours | 
| Relationship between saturation of peripheral oxygen over time and EIT findings |  | 72 hours |