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Clinical Trials in Sweden / NCT06906263
Recruiting Observational

Complications Related to the Anaesthesia During Airway Endoscopy in Children With Tracheostomy.

NCT06906263 · tracked via the Priya Life Science Sweden tracker
Sponsor
Karolinska Institutet
Phase
Observational
Started
2025-03-31
Last updated
2026-03-20

Condition(s) studied

Anesthesia ComplicationTracheostomy ComplicationsChildren Receiving General Anesthesia

Study summary

The goal of this observational study is to investigate the incidence of severe anaesthesiologic complications during anaesthesia in children with tracheostomy undergoing surveillance airway endoscopy. The main question it aims to answer is how common severe anaesteshiologic complications are in these patients and investigate if there is an association between severe anaesthesiologic complications and patient related factors.

Primary outcome: The incidence of severe anaesthesiologic complications in children with tracheostomy undergoing surveillance airway endoscopy.

Secondary outcome: The association between severe anaesthesiologic complications and patient related factors: age at tracheostomy, age at surveillance endoscopy, ventilator dependence, current and previously diagnosed tracheostomy related airway complications.

All children under 18 yrs. of age with a tracheostomy accepted for general anaesthesia undergoing surveillance airway endoscopy at the Long term Intensive Care unit at Karolinska University Hospital Stockholm Sweden will be eligable for inclusion. The anaesthesia will be conducted according to current practise and complications will recorded by the anaesthesiologist in charge. Participants may only be included several times during the study period.

Eligibility

Sex
ALL
Min age
—
Max age
18 Years
Healthy volunteers
No
All patients: under the age of 18 years with tracheostomy undergoing surveillance airway endoscopy approved for anesthesia will be included within the time frame of the study (3 years). Patients may be included multiple times during the study period. Exclusion Criteria: Patients will be excluded from the study if the airway endoscopy is a non-elective emergency procedure. Patients undergoing concurrent major surgery during the same session will be included in the study but excluded from analysis of postoperative symptoms (secondary outcome measure). This is because postoperative well-being cannot be reliably attributed to the airway endoscopy alone when major surgery is performed simultaneously. The same patient may be eligible for inclusion at multiple time points during the inclusion period if subject to subsequent airway endoscopies that meet the inclusion criteria.

Primary outcome measure(s)

  • severe anaesthesiologic complications — Perioperative
    The incidence of severe anaesthesiologic complications in children with tracheostomy undergoing surveillance airway endoscopy.

Trial sites (1)

FacilityCityRegionStatus
Pediatric Perioperative Medicine and Intensive Care Solna Sweden Recruiting

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Other trials for the same condition

"Airway Complications in Pediatric Patients With Tracheostomies: To What Extent Can Symptoms Identified by Caregivers or Pediatricians Serve as Predictors for Airway Complications Confirmed Through Surveillance Endoscopy?" Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06906263 on ClinicalTrials.gov ↗ ← All trials in Sweden