Condition: Surveillance · Endoscopy · Tracheostomy Complication · Sponsor: Karolinska Institutet
Study Objective: This observational study aims to prospectively investigate to what extent tracheostomy-related complications in children are asymptomatic or associated with symptoms when detected through surveillance airway endoscopy. We also aim at investigating how reliable caregiver reports and investigations by pediatriscians are in identifying symptoms associated with severe tracheostomy-related airway complications. Study Population: The study population comprises children under 18 years of age undergoing follow-up at the Long-Term Intensive Care Unit (LIVA) at Karolinska University Hospital in Stockholm, Sweden. Research Questions: 1. To what extent are tracheostomy-related complications in children asymptomatic when detected through surveillance airway endoscopy? 2. How reliable are caregiver reports in identifying symptoms associated with tracheostomy-related airway complications? Methods: Children scheduled for surveillance airway endoscopy are admitted to LIVA. Upon admission, the caregiver is asked to complete a short questionnaire regarding symptoms that may indicate a tracheostomy-related complication. After the questionnaire has been completed, the child will be examined by the responsible paediatrician, with the aim of identifying any signs or symptoms that could indicate an airway complication. The examination includes physical examination and medical history conducted according to a predefined protocol. The airway endoscopy is performed by an ENT s…
This description comes directly from the study's public registry record.
Ida Engqvist, MD · +46(0)768455333 · ida.engqvist@regionstockholm.se
Eva Hedlund, MD, PhD · +46(0)707421285 · eva.h.hedlund@regionstockholm.se
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| LIVA, Barn PMI, Karolinska Universitetssjukhuset Solna | Solna, Sweden | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07121517