Continuous Regional Analysis Device for Neonate Lung

Acute Respiratory Distress Syndrome Clinical Trial

— CRADL  

Official title:

Continuous Regional Analysis Device for Neonate Lung

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02962505
• Other study ID #: 668259
• Status: Completed
• Start date: November 2016
• Est. completion date: March 3, 2019

Study information

• Verified date: March 2019
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 3, 2019
• Est. primary completion date: March 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Bronchiolitis
• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Bronchiolitis
• Infant Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Locations

Country	Name	City	State
Cyprus	Archbishop Makarios III Hospital	Nicosia
Finland	Oulu University Hospital	Oulu
Netherlands	Academic Medical Center	Amsterdam
Netherlands	VU University Medical Center	Amsterdam

Sponsors (11)

Lead Sponsor	Collaborator
University of Schleswig-Holstein	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, Studio Fifield, SWISSTOM AG, University College, London, University of Geneva

Countries where clinical trial is conducted

Cyprus,  Finland,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in right-to-left and/or anteroposterior ventilation distribution by >10% compared with baseline		72 hours
Primary	Time and duration of right-to-left or left-to-right ventilation ratio >2:1		72 hours
Primary	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	Relationship between time of onset/end of non-invasive respiratory support and EIT findings		72 hours
Secondary	Relationship between time of intubation/extubation and EIT findings		72 hours
Secondary	Relationship between time of suctioning and EIT findings		72 hours
Secondary	Relationship between time and type of posture change and EIT findings		72 hours
Secondary	Relationship between time of surfactant administration and EIT findings		72 hours
Secondary	Relationship between time of clinically indicated radiological examination and EIT findings		72 hours
Secondary	Relationship between time of recruitment manoeuvre and EIT findings		72 hours
Secondary	Relationship between time of confirmed pneumothorax and EIT findings		72 hours
Secondary	Relationship between time of confirmed endotracheal tube malposition and EIT findings		72 hours
Secondary	Relationship between primary cause of respiratory failure and EIT findings		72 hours
Secondary	Relationship between fraction of inspired oxygen over time and EIT findings		72 hours
Secondary	Relationship between saturation of peripheral oxygen over time and EIT findings		72 hours