Acute Bronchiolitis, Acute Respiratory Distress Syndrome, Infant Respiratory Distress Syndrome
Conditions
Brief summary
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
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.
Interventions
None listed
Sponsors
Middlesex University London
University College, London
NICU of Makarios III Hospital-The Ministry of Health for the Republic of Cyprus
Bio-Medical Research Foundation
University of Geneva
Linneuniversitetet
SWISSTOM AG
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Studio Fifield
Panaxea
University Hospital Schleswig-Holstein
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 7 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 72 hours | 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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 fraction of inspired oxygen over time 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 time of recruitment manoeuvre and EIT findings | 72 hours |
| Relationship between saturation of peripheral oxygen over time and EIT findings | 72 hours |
| 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 |
Countries
Cyprus, Finland, Netherlands
Outcome results
None listed