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Continuous Regional Analysis Device for Neonate Lung (CRADL)

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ClinicalTrials.gov Identifier: NCT02962505
Recruitment Status : Recruiting
First Posted : November 11, 2016
Last Update Posted : November 21, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Infant Respiratory Distress Syndrome Acute Bronchiolitis Acute Respiratory Distress Syndrome

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 Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Continuous Regional Analysis Device for Neonate Lung
Study Start Date : November 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

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Ages Eligible for Study:   up to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study specifically focuses on the EIT monitoring of preterm and term neonates, small infants and children up to the age of 7 years treated in NICU and PICU as this is the population where the need for regional lung function monitoring tools is most urgently needed to optimize the ventilator therapy, validate the effectiveness, efficacy and safety of nursing and medical interventions (endotracheal suctioning, posture changes, surfactant therapy, alveolar recruitment, etc.) and prevent/minimize the occurrence of acute (pneumothorax, endotracheal tube misplacement) and chronic (chronic lung disease or bronchopulmonary dysplasia) adverse effects.

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02962505

Contact: Inez Frerichs, MD +4943159720971 inez.frerichs@uksh.de
Contact: Tobias Becher, MD +4943159720980 tobias.becher@uksh.de

Archbishop Makarios III Hospital Recruiting
Nicosia, Cyprus
Contact: Christina Karaoli       christinakaraoli@gmail.com   
Oulu University Hospital Recruiting
Oulu, Finland
Contact: Merja Kallio       merja.kallio@oulu.fi   
Papageorgiou Hospital Not yet recruiting
Thessaloníki, Greece
Contact: Ilias Chatziioannidis       drilias@windowslive.com   
Academic Medical Center Recruiting
Amsterdam, Netherlands
Contact: Anton Van Kaam, MD       a.h.vankaam@amc.uva.nl   
Sponsors and Collaborators
University of Schleswig-Holstein
Middlesex University London
University College, London
NICU of Makarios III Hospital-The Ministry of Health for the Republic of Cyprus
Bio-Medical Research Foundation
University of Geneva
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Studio Fifield
Panaxea B.V.
Study Chair: Inez Frerichs, MD University Medical Center SH, Kiel , Germany
More Information

Responsible Party: Inez Frerichs, Prof. Dr. Inéz Frerichs, University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT02962505     History of Changes
Other Study ID Numbers: 668259
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Bronchial Diseases
Lung Diseases, Obstructive
Respiratory Tract Infections
Lung Injury