Anaesthesia risks during airway endoscopy for children with a tracheostomy
Complications Related to the Anaesthesia During Airway Endoscopy in Children With Tracheostomy.
We will see how often children with a tracheostomy have serious anesthesia problems when they undergo surveillance airway endoscopy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Solna) |
| Trial ID | NCT06906263 on ClinicalTrials.gov |
What this trial studies
This is an observational project at the Long-term Intensive Care Unit (LIVA) at Karolinska that follows children under 18 with tracheostomies who undergo elective surveillance airway endoscopy under general anesthesia. Investigators will record the incidence of severe anesthesia-related complications during these procedures and collect patient factors such as age at tracheostomy, age at endoscopy, ventilator dependence, and prior tracheostomy-related airway problems. Emergency airway procedures are excluded, and cases with concurrent major surgery will be included but omitted from postoperative symptom analyses. Data will be used to explore whether certain patient characteristics are associated with higher complication rates.
Who should consider this trial
Good fit: Children under 18 with a tracheostomy who are scheduled for elective surveillance airway endoscopy under general anesthesia are eligible.
Not a fit: Children undergoing emergency airway endoscopy or those having major concurrent surgery during the same session may not benefit from this study's findings.
Why it matters
Potential benefit: If successful, the results could help clinicians identify higher-risk children and personalize surveillance scheduling and anesthetic planning to improve safety.
How similar studies have performed: There are few large prior studies specifically measuring anesthesia complication rates in children with tracheostomy, so this observational approach is relatively novel for this group.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Solna
- Pediatric Perioperative Medicine and Intensive Care — Solna, Sweden (Recruiting)
Study contacts
- Study coordinator: Ida Engqvist, M.D
- Email: ida.engqvist@regionstockholm.se
- Phone: +46 (0) 768455333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.