|- candidate number||24035|
|- NTR Number||NTR5950|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-mrt-2016|
|- Secondary IDs||MEC2016-235 |
|- Public Title||Central airways mechanics|
|- Scientific Title||Assessment of central airways mechanics using Magnetic Resonance Imaging (MRI) and bronchoscopy: a comparison|
|- hypothesis||The new MRI protocol will be sensitive enough to detect a diagnostic change of > or = 50% change from the normal normal shaped trachea.|
|- Healt Condition(s) or Problem(s) studied||Tracheobronchomalacia|
|- Inclusion criteria||• Indication for bronchoscopy as decided by the treating paediatric chest physician;|
• Aged 6 years or above;
• Ability to perform spirometry and spirometry controlled or technician controlled MRI
• Informed consent from the parents / guardians.
|- Exclusion criteria||• Any contraindications to MRI|
• In the case any contra indications to administering bronchodilator, this part of the protocol will be omitted
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-jun-2016|
|- planned closingdate||1-jun-2018|
|- Target number of participants||60|
|- Primary outcome||sensitivity and specificity of MRI as a diagnostic tool to assess central airway collapsibility|
|- Secondary outcome||to assess concordance between MRI and bronchoscopy
airway lumen reduction scores of both MRI and bronchoscopy to assess associations between MRI/ bronchoscopy scores and pulmonary function test (PFT) parameters|
|- Timepoints||60 patients in two years|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||M.D. PhD Student P. Ciet|
|- CONTACT for SCIENTIFIC QUERIES||M.D. PhD Student P. Ciet|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam, Erasmus Medical Center, Sophia Children's Hospital|
(Source(s) of Monetary or Material Support)
|- Brief summary||: Central airways mechanics in pediatric diseases is little known in vivo. Acute and chronic airway inflammation can produce increase softness of the tracheal and bronchial wall, with so resulting tracheobronchomalacia (TBM) (1).Central airways are mostly assessed with flexible bronchoscopy and CT. Bronchoscopy is considered the gold standard modality, because it allows direct visualization of the airway. However, bronchoscopy is an invasive technique, limited to assessment during tidal breathing and requiring general anaesthesia (3). For these reasons, CT is combined with bronchoscopy. CT has high temporal and spatial resolutions that allow direct and precise measurement of the central airway. Moreover CT supplies additional information about the structures surrounding the airway and about the lung parenchyma. One limitation of CT is the radiation exposure that for pediatric patient is still matter of concern.To overcome this limitation of CT, magnetic resonance imaging (MRI) has been introduced in airway imaging. MRI is a free-radiation technique that enables repeated and dynamic acquisition (8). Dynamic acquisitions (cine-MRI) are needed for better understanding central airways mechanics, because they elicit the driving forces that regulate inspiratory and expiratory changes. The diagnostic performance of cine-MRI has never been compared to bronchoscopy. If MRI will prove to be as good as bronchoscopy to diagnose central airways diseases, it will be possible to reduce the number of invasive bronchoscopy. We developed a new MRI protocol for airway imaging that proved to be feasible in pediatric patients (9).|
Objective: We hypothesize that the new MRI protocol will be sensitive enough to detect a diagnostic change of ¡Ý 50% change from the normal shaped trachea. To test this hypothesis, the primary objective of this study is to determine sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of our MRI protocol compared to flexible bronchoscopy, used as reference test. Secondary aims include: 1) assessing concordance between TBM severity, as determined by MRI and bronchoscopy; 2) relationship between severity assessment of MRI and bronchoscopy with pulmonary function tests (PFT) and respiratory symptoms; and 3) to assess the influence of bronchodilator in airways mechanics.
Study design: Prospective, observational study
Study population: children aged 6 years and above referred to Sophia Children¡¯s Hospital for bronchoscopy. A total of 60 patients who are already scheduled for a bronchoscopy under general anaesthesia will be recruited.
Intervention (if applicable): Not applicable
Main study parameters/endpoints: The diagnostic performance of MRI to assess central airways cross-sectional changes in comparison to bronchoscopy, the current gold standard to diagnose airway diseases.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation in the study will add an extra visit to Sophia Children¡¯s Hospital. Total visit time will be approx. 1.45 hours: 40 minutes MRI scanning, 55 minutes lung function testing, training and bronchodilator (including 10 minute break), and 10 minutes for consent and questionnaire. Early and safe diagnosis of airway disease is beneficial in initiating appropriate treatment such as earlier commencement of antibiotic treatment during winter months. Finally, appropriateness of using bronchodilators for TBM symptoms, the most common, but potentially least appropriate treatment of TBM symptoms, will be assessed.
|- Main changes (audit trail)|
|- RECORD||3-mrt-2016 - 23-aug-2016|