The overall aim of the study is to correlate the anatomical and functional anatomy of the larynx, as seen on MRI to various functional outcome measures in patients who underwent open airway surgery for LTS. The specific aims of this study are: 1) to…
ID
Source
Brief title
Condition
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcomes of this study are the findings on MRI. In the first sub
study we will classify post-surgical changes, this will compared to the normal
anatomy of the larynx in healthy children. In the second sub study we will
quantify the extent and location of fibrosis. Lastly, in the third sub study,
we will quantify the mobility of the vocal cords. This will compared to the
normal vocal cord mobility as seen in healthy children.
Secondary outcome
The MRI findings from the first and second sub study will be correlated to
clinical status. Clinical status will be assessed through health related
questionnaires and spirometry. Findings from the third sub study will be
correlated to the rate of dysphonia assessed by the Dysphonia Severity Index
and voice questionnaires.
Background summary
Pediatric laryngeal stenosis (LTS) has various congenital and acquired causes.
Open airway surgery, through laryngotracheal reconstruction or cricotracheal
resection, is done to repair the airway without tracheostomy, while maintaining
swallowing and vocal function. Although the rate of successful surgical
interventions has improved over the last decades, sequelae, such as respiratory
complaints and dysphonia, are not uncommon. Anatomical and functional risk
factors leading to these sequelae are not well understood. Imaging of the
larynx post- surgery is likely to improve our understanding of these
pathophysiological risk factors. The development of Magnetic Resonance Imaging
(MRI), as an ionizing radiation- free alternative to Computer Tomography,
provides opportunities for safe morphological and functional imaging of the
upper airway in these children.
Study objective
The overall aim of the study is to correlate the anatomical and functional
anatomy of the larynx, as seen on MRI to various functional outcome measures in
patients who underwent open airway surgery for LTS. The specific aims of this
study are: 1) to correlate anatomical changes related to surgery, as seen on
MRI, to clinical outcome, 2) to correlate the extent and location of fibrosis,
as seen on MRI, to clinical outcome and 3) to correlate dynamical vocal cord
function, as seen on MRI, to dysphonia. We hypothesize that MRI can be used as
an imaging technique, without the need for sedation and without the exposition
to ionizing- radiation, for extensive morphological and dynamic evaluation of
the pediatric larynx.
Study design
This study is a prospective cross- sectional study performed at the Erasmus MC-
Sophia Children*s Hospital in Rotterdam, the Netherlands.
Study burden and risks
Participation in this study will consist of a four hour visit to the Sophia
Children*s Hospital. The visit will consist of filling in questionnaires and
recording medical history (30 minutes), physical examination (10 minutes),
spirometry (30 minutes), vocal test (20 minutes), visit mock MRI (25 minutes)
and MRI (30- 45 minutes). None of these procedures are associated with a direct
risk for the patient. MRI is a radiation free technique without risk for the
children. The only adverse effect is related to the noisy and restricted
environment of the MRI scanner that can induce claustrophobia. Appropriate
training will be performed to avoid this adverse effect, and each subject will
have the opportunity to withdraw from the study at any moment. The main benefit
for this group of children will be a better understanding of anatomical and
functional risk factors related to adverse outcome post-open airway surgery. A
better understanding of these factors will improve the healthcare for this
patient group, the better quantification of post- surgical anatomical changes
will help develop future interventions and will allow for the development of
tailored management programs according to the specific morphological and/or
functional deficit. In addition, the further developed MRI of the pediatric
larynx, could replace potentially harmful current imaging methods.
Wytemaweg 80
Rotterdam 3015CN
NL
Wytemaweg 80
Rotterdam 3015CN
NL
Listed location countries
Age
Inclusion criteria
Patient: undergone surgical reconstruction for a congenital or acquired laryngeal stenosis between 1994 and 2018( 6-30 years), able to follow instructions during MRI, informed consent by parents and/or patient
Volunteer: age between 6 and 30 years, able to follow instructions during MRI, informed consent by parents and/or volunteer
Exclusion criteria
Patient: contra- indications for MRI, inability to undergo MRI, any current lung infection (symptoms of respiratory distress, severe cough, antibiotics for current lung infection), chronic oxygen need, tracheotomy cannula in situ
Volunteer: contra- indications for MRI, inability to undergo MRI, any current lung infection (symptoms of respiratory distress, severe cough, antibiotics for current lung infection), chronic oxygen need, co- morbidities of the lungs, airways or vocal cords
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL64497.078.17 |