Continuous Regional Analysis Device for Neonate Lung

NCT02962505 | Completed

• 1 other identifier: 668259
• Study Type: observational
• Target: 200
• Locations: 3 countries
• Sites: 4

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.

Conditions

Infant Respiratory Distress Syndrome; Acute Bronchiolitis; Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• 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

Eligibility Criteria

• Age: Up to 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead
• Middlesex University London: collaborator
• University College, London: collaborator
• NICU of Makarios III Hospital-The Ministry of Health for the Republic of Cyprus: collaborator
• Bio-Medical Research Foundation: collaborator
• University of Geneva: collaborator
• Linneuniversitetet: collaborator
• SWISSTOM AG: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• Studio Fifield: collaborator
• Panaxea: collaborator

Study Sites (4)

Archbishop Makarios III Hospital

Nicosia, Cyprus

Location

Oulu University Hospital

Oulu, Finland

Location

Academic Medical Center

Amsterdam, Netherlands

Location

VU University Medical Center

Amsterdam, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 34898392 DERIVED

MeSH Terms

Conditions

Pulmonary Atelectasis; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Inez Frerichs, MD

  University Medical Center SH, Kiel , Germany

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Inéz Frerichs

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 11, 2016
• Study Start: November 1, 2016
• Primary Completion: March 3, 2019
• Study Completion: March 3, 2019
• Last Updated: March 21, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1); FI (1); NL (2)