Actively Recruiting

Age: 0 - 18Years
All Genders
ID07121517

Airway Complications in Pediatric Patients With Tracheostomies: To What Extent Can Symptoms Identified by Caregivers or Pediatricians Predict Airway Complications Confirmed Through Surveillance Endoscopy?

Led by Karolinska Institutet · Updated on 2026-02-17

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

K

Karolinska Institutet

Lead Sponsor

R

Region Stockholm

Collaborating Sponsor

AI-Summary

What this Trial Is About

This observational study focuses on children under 18 years of age with tracheostomies who are followed at the Long-Term Intensive Care Unit (LIVA) at Karolinska University Hospital in Sweden. It aims to determine how often tracheostomy-related airway complications are asymptomatic or linked to symptoms detected through surveillance airway endoscopy. Additionally, the study evaluates how accurately caregivers and pediatricians can identify symptoms related to serious airway complications. Children scheduled for regular surveillance airway endoscopy under anesthesia as part of their follow-up at LIVA will be included. Upon admission, caregivers complete a questionnaire about possible symptoms of airway complications. The child then undergoes a physical exam and medical history review by a pediatrician following a set protocol. An ENT surgeon, unaware of the questionnaire and pediatrician exam results, performs the airway endoscopy to identify complications. During the study, researchers will compare caregiver and pediatrician reports with findings from airway endoscopy to assess symptom reliability. The main measurements include the proportion of patients with serious tracheostomy airway complications who show no symptoms before endoscopy. The study spans two years, with ongoing surveillance and the collection of data on symptoms and complications. Ethical approval has been obtained to conduct this research.

CONDITIONS

Brief 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?"

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children under 18 years old with a tracheostomy
  • Scheduled for surveillance airway endoscopy under anesthesia as part of regular follow-up at the Long-Term Intensive Care Unit (LIVA) at Karolinska University Hospital
  • Patients may be included multiple times during the study period
Not Eligible

You will not qualify if you...

  • Undergoing airway endoscopy that is not part of the surveillance airway endoscopy program
  • Emergency endoscopies are excluded

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for eligibility screening and scheduling surveillance endoscopy

Surveillance

Duration - Up to 2 years

Participants undergo regular multidisciplinary assessments and surveillance airway endoscopies under anesthesia to detect tracheostomy-related airway complications.

1 to 2 surveillance airway endoscopies annually with additional multidisciplinary assessments

Trial Site Locations

Total: 1 location

1

LIVA, Barn PMI, Karolinska Universitetssjukhuset Solna

Solna, Sweden, 17176

Actively Recruiting

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Research Team

I

Ida Engqvist, MD

E

Eva Hedlund, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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