Continuous Regional Analysis Device for Neonate Lung (CRADL)

University Hospital Schleswig-Holstein (UKSH)

Status: Completed

Conditions: Acute Bronchiolitis; Infant Respiratory Distress Syndrome; Acute Respiratory Distress Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT02962505

668259

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: Under 7 years old

Volunteers: No Healthy Volunteers

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