Actively Recruiting

Age: 0 - 18Years
All Genders
NCT07121517

"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?"

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

100

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

Sponsors

K

Karolinska Institutet

Lead Sponsor

R

Region Stockholm

Collaborating Sponsor

AI-Summary

What this Trial Is About

Study Objective: This observational study aims to prospectively investigate to what extent tracheostomy-related complications in children are asymptomatic or associated with symptoms when detected through surveillance airway endoscopy. We also aim at investigating how reliable caregiver reports and investigations by pediatriscians are in identifying symptoms associated with severe tracheostomy-related airway complications. Study Population: The study population comprises children under 18 years of age undergoing follow-up at the Long-Term Intensive Care Unit (LIVA) at Karolinska University Hospital in Stockholm, Sweden. Research Questions: 1. To what extent are tracheostomy-related complications in children asymptomatic when detected through surveillance airway endoscopy? 2. How reliable are caregiver reports in identifying symptoms associated with tracheostomy-related airway complications? Methods: Children scheduled for surveillance airway endoscopy are admitted to LIVA. Upon admission, the caregiver is asked to complete a short questionnaire regarding symptoms that may indicate a tracheostomy-related complication. After the questionnaire has been completed, the child will be examined by the responsible paediatrician, with the aim of identifying any signs or symptoms that could indicate an airway complication. The examination includes physical examination and medical history conducted according to a predefined protocol. The airway endoscopy is performed by an ENT surgeon who has not examined the patient beforehand and is not informed of the caregiver's responses nor the result of the examination by the pediatrician. However, there is no strict protocol in place to blind the surgeon to any visibly apparent symptoms or to information that may be spontaneously reported by the caregiver or paediatrician.

CONDITIONS

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?"

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 routine surveillance airway endoscopy under anesthesia
  • Receiving regular follow-up at the Long-Term Intensive Care Unit (LIVA) at Karolinska University Hospital
  • 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 routine surveillance program
  • Emergency airway endoscopies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

LIVA, Barn PMI, Karolinska Universitetssjukhuset Solna

Solna, Sweden, 17176

Actively Recruiting

Loading map...

Research Team

I

Ida Engqvist, MD

CONTACT

E

Eva Hedlund, MD, PhD

CONTACT

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here