Predicting airway problems in children with tracheostomies using caregiver and pediatrician reports.
"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?"
Karolinska Institutet · NCT07121517
We will see if symptoms reported by caregivers or pediatricians can predict airway complications found during routine surveillance endoscopy in children with tracheostomies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Karolinska Institutet (other) |
| Locations | 1 site (Solna) |
| Trial ID | NCT07121517 on ClinicalTrials.gov |
What this trial studies
This prospective observational project enrolls children under 18 with tracheostomies who are scheduled for routine surveillance airway endoscopy at the Long‑Term Intensive Care Unit (LIVA) at Karolinska University Hospital. Caregivers and pediatricians will report symptoms before the endoscopy and those reports will be compared with the endoscopic findings to determine how often complications are asymptomatic and how predictive reported symptoms are of clinically significant airway problems. Emergency endoscopies are excluded and patients may be included multiple times if they undergo repeated surveillance procedures. The goal is to inform surveillance practice by measuring the reliability of caregiver and pediatrician symptom detection for tracheostomy‑related complications.
Who should consider this trial
Good fit: Children under 18 with a tracheostomy who are scheduled for routine surveillance airway endoscopy at LIVA (Karolinska University Hospital) are the intended participants.
Not a fit: Children undergoing emergency airway endoscopy or those not followed at LIVA are excluded and unlikely to benefit directly from this study.
Why it matters
Potential benefit: If successful, the results could help clinicians target surveillance endoscopies to children at higher risk and improve early detection of life‑threatening airway complications.
How similar studies have performed: Surveillance endoscopy is an established practice, but there is limited prior evidence on how well caregiver or pediatrician symptom reports predict asymptomatic or severe tracheostomy‑related airway complications.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: All children, with tracheostomy, under the age of 18, undergoing scheduled surveillance airway endoscopy in anaesthesia as part of their regular follow-up at the Long term Intensive Care unit (LIVA) at Karolinska University Hospital are eligible for inclusion. Patients may be included several times during the study period. Exclusion criteria: All patients undergoing airway endoscopy that is not part of the surveillance airway endoscopy program will be excluded. Thus, emergency endoscopies are not included in this study.
Where this trial is running
Solna
- LIVA, Barn PMI, Karolinska Universitetssjukhuset Solna — Solna, Sweden (RECRUITING)
Study contacts
- Principal investigator: Ida Engqvist, MD — LIVA, Barn PMI, Karolinska Universitetssjukhuset, Solna, Sweden
- Study coordinator: Ida Engqvist, MD
- 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.
Conditions: Surveillance, Endoscopy, Tracheostomy Complication, Tracheostomy Complications, Tracheostomy, Children in the Pediatric Intensive Care Unit or General Pediatric Care Unit Requiring a Central Venous Catheter, surveillance, endoscopy