"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?"

NCT07121517 | Recruiting

• 1 other identifier: 2023-07493-01-V
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.To what extent are tracheostomy-related complications in children asymptomatic when detected through surveillance airway endoscopy?
2. 2.How reliable are caregiver reports in identifying symptoms associated with tracheostomy-related airway complications?

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

Keywords

surveillance; endoscopy; pediatric; intensive care unit; tracheostomy complication

Outcome Measures

Primary Outcomes (2)

• Proportion of patients who are diagnosed with a serious tracheostomy related airway complication, without associated symptoms reported by caregiver prior to airway endoscopy.

  Symtoms prior to surveillance endoscopy are recorded from caregiver reports and from clinical investigation by pediatrician upon admission. Airway complications detected through Surveillance Airway Endoscopy in children with Tracheostomy are recorded. Association between symptoms and identified airway complications is investigated.

  2 years

• Proportion of patients who are diagnosed with a serious tracheostomy related airway complication, without associated symptoms reported by a paediatrician prior to airway endoscopy.

  Symtoms prior to surveillance endoscopy are recorded from caregiver reports and from clinical investigation by pediatrician upon admission. Airway complications detected through Surveillance Airway Endoscopy in children with Tracheostomy are recorded. Association between symptoms and identified airway complications is investigated.

  2 years

Secondary Outcomes (3)

• Proportion of patients that was diagnosed with at least one serious tracheostomy related complication during the study period.

  2 years

• Proportion of surveillance airway endoscopies identifying a serious tracheostomy related airway complication without associated symptoms reported by caregiver prior to airway endoscopy.

  2 years

• Proportion of surveillance airway endoscopies identifying a serious tracheostomy related airway complication without associated symptoms reported by pediatrician prior to airway endoscopy .

  2 years

Study Arms (1)

Children with tracheostomy undergoing at LIVA

All children under 18 years with tracheostomy undergoing follow-up through the long term intensive care unit LIVA at Karolinska University Hospital Solna, Sweden will be eligible for inclusion. This is a majority of the children living with tracheostomy in Sweden.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children below the age of 18 with tracheostomy undergoing follow-up through the Long term Intensive Care Unit at Karolinska University Hospital in Stockholm Sweden scheduled for surveillance airway endoscopy between sept 2025 and sept 2027. This includes the majority of children with tracheostomy in Sweden. Patients undergo airway endoscopy 1-2 times per year. One patient may be included more than one time. Estimated population size is approximately 100.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

LIVA, Barn PMI, Karolinska Universitetssjukhuset Solna

Solna, 17176, Sweden

RECRUITING

Study Officials

• Ida Engqvist, MD

  LIVA, Barn PMI, Karolinska Universitetssjukhuset, Solna, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ida Engqvist, MD

CONTACT

+46(0)768455333; ida.engqvist@regionstockholm.se

Eva Hedlund, MD, PhD

CONTACT

+46(0)707421285; eva.h.hedlund@regionstockholm.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, Principal Investigator

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 13, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

SE (1)