Clinical trial NCT02962505: Continuous Regional Analysis Device for Neonate Lung
Official title: Continuous Regional Analysis Device for Neonate Lung
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant Respiratory Distress Syndrome
Acute Bronchiolitis
Acute Respiratory Distress Syndrome
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: Middlesex University London
name: University College, London
name: NICU of Makarios III Hospital-The Ministry of Health for the Republic of Cyprus
name: Bio-Medical Research Foundation
name: University of Geneva
name: Linneuniversitetet
name: SWISSTOM AG
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Studio Fifield
name: Panaxea
First posted: 2016-11-11
Enrollment: 200
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in aggregate measure of ventilation homogeneity (coefficient of variation and global inhomogeneity index of regional tidal volume) by > 10% compared with baseline
timeFrame: 72 hours
measure: Change in right-to-left and/or anteroposterior ventilation distribution by >10% compared with baseline
timeFrame: 72 hours
measure: Time and duration of right-to-left or left-to-right ventilation ratio >2:1
timeFrame: 72 hours
measure: Percentage of EIT examination time with at least 26 out of 32 sensors exhibiting skin contact impedance of < 700 Ohm
timeFrame: 72 hours
Secondary outcomes:
measure: Relationship between time of onset/end of non-invasive respiratory support and EIT findings
timeFrame: 72 hours
measure: Relationship between time of intubation/extubation and EIT findings
timeFrame: 72 hours
measure: Relationship between time of suctioning and EIT findings
timeFrame: 72 hours
measure: Relationship between time and type of posture change and EIT findings
timeFrame: 72 hours
measure: Relationship between time of surfactant administration and EIT findings
timeFrame: 72 hours
measure: Relationship between time of clinically indicated radiological examination and EIT findings
timeFrame: 72 hours
measure: Relationship between time of recruitment manoeuvre and EIT findings
timeFrame: 72 hours
measure: Relationship between time of confirmed pneumothorax and EIT findings
timeFrame: 72 hours
measure: Relationship between time of confirmed endotracheal tube malposition and EIT findings
timeFrame: 72 hours
measure: Relationship between primary cause of respiratory failure and EIT findings
timeFrame: 72 hours
measure: Relationship between fraction of inspired oxygen over time and EIT findings
timeFrame: 72 hours
measure: Relationship between saturation of peripheral oxygen over time and EIT findings
timeFrame: 72 hours
Other outcomes:
Locations:
city: Nicosia
country: Cyprus
facility: Archbishop Makarios III Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
Study officials:
affiliation: University Medical Center SH, Kiel , Germany
name: Inez Frerichs, MD
role: STUDY_CHAIR
References:
citation: 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.