Predicting airway problems in children with tracheostomies using caregiver and pediatrician reports.
Official title: "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?"
Run by Karolinska Institutet · NCT07121517 · Data updated 2026-11-12
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 |
|---|---|
| Ages | Any age to 18 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Solna) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | August 31, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | February 17, 2026 |
| Trial ID | NCT07121517 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Children undergoing emergency airway endoscopy or those not followed at LIVA are excluded and unlikely to benefit directly from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Incremental Instrumental Dead Space vs Capping Trial Before Removing a Tracheostomy
This study tests whether adding extra tubing to the ventilator circuit (without blocking the tube) helps decide when a patient is ready to breathe on their own after a tracheostomy better than the standard capping trial.
-
Structured education for families of patients with tracheostomy in the ICU
This trial tests whether giving a structured education session to family members of ICU patients with tracheostomies can reduce their state anxiety and improve well-being and satisfaction with care.
-
Using a virtual reality headset during endoscopy to improve operator comfort
This study will try the Apple Vision Pro headset during colonoscopy, EUS, and ERCP to see if it makes the endoscopist more comfortable and is practical to use during procedures.
-
Use of invasive home ventilation in Denmark
This project will see how often people with neuromuscular diseases or spinal cord injuries in Denmark used invasive home mechanical ventilation between 2016 and 2025 and what their one-year outcomes were.
-
Immersion training for gastroscopy and colonoscopy trainees.
This project will test whether immersive training for gastroscopy and colonoscopy helps trainee endoscopists improve their skills and gives good value for endoscopy services.
-
Improving care and surveillance of fevers in the DRC
This project tracked people with recent fevers at two hospitals in the DRC to see what causes their fevers, how they are treated, and whether biomarkers like CRP relate to outcomes and antibiotic use.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.