Continuous Regional Analysis Device for Neonate Lung

University Hospital Schleswig-Holstein200 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Infant Respiratory Distress Syndrome Acute Bronchiolitis Acute Respiratory Distress Syndrome

Eligibility

Sex: ALLMax age: 7 Years

Medical Language ↔ Plain English

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

Locations (4)

Archbishop Makarios III Hospital

Nicosia, Cyprus

Oulu University Hospital

Oulu, Finland

Academic Medical Center

Amsterdam, Netherlands

VU University Medical Center

Amsterdam, Netherlands

Outcomes

Primary Outcomes

Change in aggregate measure of ventilation homogeneity (coefficient of variation and global inhomogeneity index of regional tidal volume) by > 10% compared with baseline

Time frame: 72 hours

Change in right-to-left and/or anteroposterior ventilation distribution by >10% compared with baseline

Time frame: 72 hours

Time and duration of right-to-left or left-to-right ventilation ratio >2:1

Time frame: 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.

Time frame: 72 hours

Secondary Outcomes

Relationship between time of onset/end of non-invasive respiratory support and EIT findings

Time frame: 72 hours

Relationship between time of intubation/extubation and EIT findings

Time frame: 72 hours

Relationship between time of suctioning and EIT findings

Time frame: 72 hours

Relationship between time and type of posture change and EIT findings

Time frame: 72 hours

Relationship between time of surfactant administration and EIT findings

Data from ClinicalTrials.gov

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