Primary Objectives: 1. To determine the consequences in infants and children who had a laryngotracheal reconstruction or cricotracheal resection, regardinga. quality of the voiceb. physical strain Secondary objectives:2. To determine the…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
verworven luchtwegaandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the quality of the voice, the Dysphonia Severity Index (DSI) will
be done by speech pathologist M.H. Measurements for the following four
parameters of the DSI will be obtained: highest fundamental frequency, lowest
intensity, maximum phonation time and jitter.
To determine the physical strain, the following study parameters/ endpoints
will be determined:
- Clinical history will be taken regarding complaints related to exercise
capacity.
- Physical examination will be done; croupscore, growth and signs regarding
physical strain will be determined.
- Fiberscopy will be done and recorded to visualize the anatomy and
functionality of the larynx.
- Spirometry will be done and the forced vital capacity (FVC), forced
expiratory volume in 1 second (FEV1), maximal flow at 25% of FVC remaining in
the lung (FEF25%) and forced inspiratory volume in 1 second (FIV1) will be
measured.
- The Bruce treadmill test will be done. The maximal endurance time will be
measured and serve as a criterion of exercise capacity. Before and during the
test heart rate and transcutaneous oxygen saturation will be measured.
- The borgscore will be determined, a subjective measurement for the exercise
capacity.
- An airway-resistance test will be performed to determine the resistance in
the airway during expiration in kPa/L/s.
Secondary outcome
To determine the quality of life influenced by the quality of the voice, the
Paediatric Voice Handicap Index (PVHI) or the Voice Handicap Index (VHI) will
be used, depending on the age. The PVHI provides a measurement of the severity
of a voice disorder in three domains: emotional, physical and functional. It
provides the parents perception of the severity of the voice of his/ her son/
daughter and its impact on the daily life of their child.
To determine the health-related quality of life, the following validated
questionnaires will be used, depending on the age: Child Health Questionnaire
CHQ-CF87, Infant and Toddler Quality of Life Questionnaire ITQOL and Child
Health Questionnaire - Parent Form 50 CHQ-PF50.
To determine self-esteem, the standardised and validated questionnaires *Self-
Perception Profile for Children* (SPP-C), *Self-Perception Profile for
Adolescents* (SPP-A) or *Nederlandse Persoonlijkheids Vragenlijst* (NPV-2) will
be used, depending on the age. Furthermore, the scar will be judged by the
children themselves and the physician, using a Visual Analog Score (VAS).
Background summary
Acquired laryngeal stenosis in children is a serious long-term complication of
prolonged endotracheal intubation (>= 24h). In many children who develop a
laryngeal stenosis, endoscopic treatment, a tracheostomy or laryngotracheal
reconstruction is necessary. The goal of such surgery is to create an airway
that is adequate for survival in the absence of a tracheostomy. However, an
impaired quality of the voice, physical limitations as well as adverse
psychological consequences are seen in this group of children who often have an
extensive medical history, have had a tracheostomy for a long time before
surgery and have had a laryngotracheal reconstruction.
Hypotheses
1. Infants and children after a laryngotracheal reconstruction or cricotracheal
resection because of an acquired laryngeal stenosis, have
a. impaired quality of the voice
b. decreased physical strain
2. Infants and children after a laryngotracheal reconstruction or cricotracheal
resection because of an acquired laryngeal stenosis, have
a. decreased quality of life caused by the impaired quality of the voice
b. decreased quality of life caused by the decreased physical strain
c. lower self-esteem because of the scar in the neck after tracheostomy and
surgery
Study objective
Primary Objectives:
1. To determine the consequences in infants and children who had a
laryngotracheal reconstruction or cricotracheal resection, regarding
a. quality of the voice
b. physical strain
Secondary objectives:
2. To determine the consequences in infants and children who had a
laryngotracheal reconstruction or cricotracheal resection, regarding
a. quality of life influenced by quality of the voice
b. quality of life influenced by physical strain
c. self-esteem
Study design
The study is a descriptive cross-sectional study performed at the outpatient
clinic at the Department of Otorhinolaryngology in the Sophia Children*s
Hospital, Erasmus Medical Center, Rotterdam, the Netherlands.
Study burden and risks
Participating infants, children and their parents will receive an invitation
for the outpatient clinic at the Department of Otorhinolaryngology in the
Erasmus MC - Sophia Children*s Hospital.
First, they will be sent a covering letter, a patient information letter and an
informed consent form. If informed consent is signed and send back,
participating infants, children and their parents will receive an invitation
for the outpatient clinic and several questionnaires. The parents of the
children or children themselves, if they are capable and depending on the age,
will be asked to fill out the questionnaires at home. The following research
will be done at the outpatient clinic during their half day visit: clinical
history, physical examination, fiberscopy, spirometry, treadmill test,
determine borgscore, airway resistance and Dysphonia Severity Index. The
regular follow-up of these children at the outpatient clinic varies between
several times a year and no regular follow-up anymore.
Children might provide benefit from this study not only because of the thorough
assessment of their health, but in addition they will be referred for further
specialist care when needed. Furthermore, there are no serious adverse events
associated with participation to the study.
Dr Molewaterplein 60
3015 GJ Rotterdam
NL
Dr Molewaterplein 60
3015 GJ Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Infants and children in whom prolonged intubation has caused a laryngeal stenosis and who had a laryngotracheal reconstruction or a cricotracheal resection at Sophia Children*s Hospital between 1994 and 2009. Informed consent has to be signed.
Exclusion criteria
Infants and children who had a laryngotracheal reconstruction or a cricotracheal resection because of a congenital laryngeal stenosis at Sophia Children*s Hospital.
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 | NL33690.078.10 |