Acute Respiratory Distress Syndrome Clinical Trial
— CRADLOfficial title:
Continuous Regional Analysis Device for Neonate Lung
NCT number | NCT02962505 |
Other study ID # | 668259 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 2016 |
Est. completion date | March 3, 2019 |
Verified date | March 2019 |
Source | University of Schleswig-Holstein |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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.
Status | Completed |
Enrollment | 200 |
Est. completion date | March 3, 2019 |
Est. primary completion date | March 3, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 7 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Cyprus | Archbishop Makarios III Hospital | Nicosia | |
Finland | Oulu University Hospital | Oulu | |
Netherlands | Academic Medical Center | Amsterdam | |
Netherlands | VU University Medical Center | Amsterdam |
Lead Sponsor | Collaborator |
---|---|
University of Schleswig-Holstein | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Bio-Medical Research Foundation, Linneuniversitetet, Middlesex University London, NICU of Makarios III Hospital-The Ministry of Health for the Republic of Cyprus, Panaxea, Studio Fifield, SWISSTOM AG, University College, London, University of Geneva |
Cyprus, Finland, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | ||
Primary | Change in right-to-left and/or anteroposterior ventilation distribution by >10% compared with baseline | 72 hours | ||
Primary | Time and duration of right-to-left or left-to-right ventilation ratio >2:1 | 72 hours | ||
Primary | 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 | Relationship between time of onset/end of non-invasive respiratory support and EIT findings | 72 hours | ||
Secondary | Relationship between time of intubation/extubation and EIT findings | 72 hours | ||
Secondary | Relationship between time of suctioning and EIT findings | 72 hours | ||
Secondary | Relationship between time and type of posture change and EIT findings | 72 hours | ||
Secondary | Relationship between time of surfactant administration and EIT findings | 72 hours | ||
Secondary | Relationship between time of clinically indicated radiological examination and EIT findings | 72 hours | ||
Secondary | Relationship between time of recruitment manoeuvre and EIT findings | 72 hours | ||
Secondary | Relationship between time of confirmed pneumothorax and EIT findings | 72 hours | ||
Secondary | Relationship between time of confirmed endotracheal tube malposition and EIT findings | 72 hours | ||
Secondary | Relationship between primary cause of respiratory failure and EIT findings | 72 hours | ||
Secondary | Relationship between fraction of inspired oxygen over time and EIT findings | 72 hours | ||
Secondary | Relationship between saturation of peripheral oxygen over time and EIT findings | 72 hours |
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