Continuous Regional Analysis Device for Neonate Lung

Completed

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

• Registration Number: NCT02962505
• Lead Sponsor: University Hospital Schleswig-Holstein

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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-03
• Study First Submitted QC: 2016-11-08
• Study First Posted: 2016-11-11
• Status Verified: 2019-03
• Primary Completion: 2019-03-03
• Study Completion: 2019-03-03
• Last Update Submitted: 2019-03-19
• Last Update Posted: 2019-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time and duration of right-to-left or left-to-right ventilation ratio >2:1	72 hours
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
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 Outcome Measures

Name	Time	Method
Relationship between time of intubation/extubation 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 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 time of confirmed pneumothorax and EIT findings	72 hours
Relationship between time of confirmed endotracheal tube malposition and EIT findings	72 hours
Relationship between fraction of inspired oxygen over time and EIT findings	72 hours
Relationship between time of recruitment manoeuvre and EIT findings	72 hours
Relationship between primary cause of respiratory failure and EIT findings	72 hours
Relationship between saturation of peripheral oxygen over time and EIT findings	72 hours

Trial Locations

Locations (4)

Oulu University Hospital; 🇫🇮 Oulu, Finland

Archbishop Makarios III Hospital; 🇨🇾 Nicosia, Cyprus

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands

VU University Medical Center; 🇳🇱 Amsterdam, Netherlands