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Completed

NCT Number: NCT02962505

Continuous Regional Analysis Device for Neonate Lung

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.

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Key information

Conditions

Infant Respiratory Distress Syndrome Acute Bronchiolitis Acute Respiratory Distress Syndrome Lung Diseases Pulmonary Atelectasis Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

Up to 7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Archbishop Makarios III Hospital, Nicosia, Cyprus

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in aggregate measure of ventilation homogeneity (coefficient of variation and global inhomogeneity index of regional tidal volume) by > 10% compared with baseline

    Time frame: 72 hours

  2. Change in right-to-left and/or anteroposterior ventilation distribution by >10% compared with baseline

    Time frame: 72 hours

  3. Time and duration of right-to-left or left-to-right ventilation ratio >2:1

    Time frame: 72 hours

  4. Percentage of EIT examination time with at least 26 out of 32 sensors exhibiting skin contact impedance of < 700 Ohm

    Time frame: 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 outcomes

  1. Relationship between time of onset/end of non-invasive respiratory support and EIT findings

    Time frame: 72 hours

  2. Relationship between time of intubation/extubation and EIT findings

    Time frame: 72 hours

  3. Relationship between time of suctioning and EIT findings

    Time frame: 72 hours

  4. Relationship between time and type of posture change and EIT findings

    Time frame: 72 hours

  5. Relationship between time of surfactant administration and EIT findings

    Time frame: 72 hours

  6. Relationship between time of clinically indicated radiological examination and EIT findings

    Time frame: 72 hours

  7. Relationship between time of recruitment manoeuvre and EIT findings

    Time frame: 72 hours

  8. Relationship between time of confirmed pneumothorax and EIT findings

    Time frame: 72 hours

  9. Relationship between time of confirmed endotracheal tube malposition and EIT findings

    Time frame: 72 hours

  10. Relationship between primary cause of respiratory failure and EIT findings

    Time frame: 72 hours

  11. Relationship between fraction of inspired oxygen over time and EIT findings

    Time frame: 72 hours

  12. Relationship between saturation of peripheral oxygen over time and EIT findings

    Time frame: 72 hours

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Collaborators

  • 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
  • SWISSTOM AG
  • Studio Fifield
  • University College, London
  • University of Geneva, Switzerland

Registry information

Acronym: CRADL

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 11, 2016
Registry last updated
Mar 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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