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Follow-up of infants and children surgically treated for an acquired laryngeal stenosis after endotracheal intubation

Follow-up of infants and children surgically treated for an acquired laryngeal stenosis after endotracheal intubation - Follow-up of children surgically treated for acquired laryngeal stenosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON34296
Enrollment
79
Registered
2010-11-30
Start date
2011-01-10
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

verworven luchtwegaandoeningen larynxstenosis narrowing of the upper airway

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
2 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)