Continuous Regional Analysis Device for Neonate Lung (CRADL)

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Cyprus
  • Nicosia, Cyprus
    • Archbishop Makarios III Hospital
• Finland
  • Oulu, Finland
    • Oulu University Hospital
• Netherlands
  • Amsterdam, Netherlands
    • VU University Medical Center
  • Amsterdam, Netherlands
    • Academic Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Time and duration of right-to-left or left-to-right ventilation ratio >2:1		72 hours
Percentage of EIT examination time with at least 26 out of 32 sensors exhibiting skin contact impedance of < 700 Ohm	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.	72 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Relationship between time of onset/end of non-invasive respiratory support and EIT findings	72 hours
Relationship between time of intubation/extubation 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 recruitment manoeuvre 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 primary cause of respiratory failure and EIT findings	72 hours
Relationship between fraction of inspired oxygen over time and EIT findings	72 hours
Relationship between saturation of peripheral oxygen over time and EIT findings	72 hours

Collaborators and Investigators

• Sponsor: University Hospital Schleswig-Holstein
• Collaborators: University College, London; Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Middlesex University London; NICU of Makarios III Hospital-The Ministry of Health for the Republic of Cyprus; Bio-Medical Research Foundation; University of Geneva; Linneuniversitetet; SWISSTOM AG; Studio Fifield; Panaxea
• Investigators: Study Chair: Inez Frerichs, MD, University Medical Center SH, Kiel , Germany

Publications and helpful links

General Publications

• Becher TH, Miedema M, Kallio M, Papadouri T, Karaoli C, Sophocleous L, Rahtu M, van Leuteren RW, Waldmann AD, Strodthoff C, Yerworth R, Dupre A, Benissa MR, Nordebo S, Khodadad D, Bayford R, Vliegenthart R, Rimensberger PC, van Kaam AH, Frerichs I. Prolonged Continuous Monitoring of Regional Lung Function in Infants with Respiratory Failure. Ann Am Thorac Soc. 2022 Jun;19(6):991-999. doi: 10.1513/AnnalsATS.202005-562OC.

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): March 3, 2019
• Study Completion (Actual): March 3, 2019

Study Registration Dates

• First Submitted: November 3, 2016
• First Submitted That Met QC Criteria: November 8, 2016
• First Posted (Estimate): November 11, 2016

Study Record Updates

• Last Update Posted (Actual): March 21, 2019
• Last Update Submitted That Met QC Criteria: March 19, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Injury; Infant, Premature, Diseases; Bronchitis; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Bronchiolitis
• Other Study ID Numbers: 668259

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No