An observational study in Infant Respiratory Distress Syndrome, Acute Bronchiolitis and Acute Respiratory Distress Syndrome, sponsored by University Hospital Schleswig-Holstein. Completed at 4 sites in 3 countries. Open to participants aged Up to 7 Years. Per ClinicalTrials.gov, last updated 2019-03-21.
Sponsored by University Hospital Schleswig-Holstein · Observational
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.
308 studies on the registry are indexed under Pulmonary Atelectasis; 79 are open to participants now.
This study's enrollment of 200 is above the median of 72 across 76 observational studies indexed under Pulmonary Atelectasis.
Browse Pulmonary Atelectasis studies →University Hospital Schleswig-Holstein is the lead sponsor of 163 studies on the registry; 25 are open to participants now.
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This study specifically focuses on the EIT monitoring of preterm and term neonates, small infants and children up to the age of 7 years treated in NICU and PICU as this is the population where the need for regional lung function monitoring tools is most urgently needed to optimize the ventilator therapy, validate the effectiveness, efficacy and safety of nursing and medical interventions (endotracheal suctioning, posture changes, surfactant therapy, alveolar recruitment, etc.) and prevent/minimize the occurrence of acute (pneumothorax, endotracheal tube misplacement) and chronic (chronic lung disease or bronchopulmonary dysplasia) adverse effects.
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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
Exclusion Criteria:
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
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
Time frame: 72 hours
Relationship between time of clinically indicated radiological examination and EIT findings
Time frame: 72 hours
Relationship between time of recruitment manoeuvre and EIT findings
Time frame: 72 hours
Relationship between time of confirmed pneumothorax and EIT findings
Time frame: 72 hours
Relationship between time of confirmed endotracheal tube malposition and EIT findings
Time frame: 72 hours
Relationship between primary cause of respiratory failure and EIT findings
Time frame: 72 hours
Relationship between fraction of inspired oxygen over time and EIT findings
Time frame: 72 hours
Relationship between saturation of peripheral oxygen over time and EIT findings
Time frame: 72 hours
Plan to share: No
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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