NCT02962505

Continuous Regional Analysis Device for Neonate Lung

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: University Hospital Schleswig-Holstein · Academic / Other
• Sex: All
• Age: 7 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infant Respiratory Distress Syndrome
• Acute Bronchiolitis
• Acute Respiratory Distress Syndrome

Timeline

• Start date: 2016-11-01
• Primary completion: 2019-03-03
• Completion: 2019-03-03
• First posted: 2016-11-11
• Last updated: 2019-03-21

Locations

4 sites across 3 countries: Cyprus, Finland, Netherlands