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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02962505
Other study ID # 668259
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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