"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?"

NCT ID: NCT07121517

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-08-31

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. 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.

Detailed Description

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.

Background Children with airway obstruction due to congenital malformations, trauma, or chronic respiratory or neuromuscular conditions may require a tracheostomy. The Long-Term Intensive Care Unit (LIVA), part of the Pediatric Perioperative Medicine and Intensive Care (BPMI) at Karolinska University Hospital, has been providing specialized care for children with tracheostomies across Sweden since 1998. The care at LIVA involves assessements by a multidisciplinary team, including pediatricians, ENT specialists, pediatric anesthesiologists, nurses, physiotherapists, dietitians, speech therapists, counselors, and play therapists.

Follow-up at LIVA includes regular multidisciplinary assessments and one to two surveillance airway endoscopies under anesthesia annually, aimed at early detection of airway complications related to the tracheostomy tube. Complications such as granulomas, infections, or bleeding are often asymptomatic but can be potentially life-threatening. There is currently no national or international consensus on the optimal frequency of surveillance endoscopies, and the potential for individualizing surveillance based on risk factors, including the presentation of symptoms, remains unexplored. Given the risks associated with anesthesia, minimizing unnecessary procedures is critical.

Currently, a retrospective study is underway to examine the incidence of tracheostomy-related complications, their correlation with risk and demographic factors, and preoperative symptoms. Preliminary results indicate that 72% of patients experienced at least one tracheostomy-related complication, while only 19% exhibited symptoms prior to surveillance endoscopy according to patient records. Suprastomal granuloma was the most frequent complication observed. Interventions were required for all symptomatic patients and 71% of asymptomatic patients with identified complications. Patients using ventilators and/or cuffed cannulas had a higher incidence of complications compared to those without (88% vs. 61%, p<0.05).

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.

Ethical Approval Ethical approval for the study has been obtained (Ref. No: 2023-07493-01).

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility 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.

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Stockholm

OTHER_GOV

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Ida Engqvist

Medical doctor, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ida Engqvist, MD

Role: PRINCIPAL_INVESTIGATOR

LIVA, Barn PMI, Karolinska Universitetssjukhuset, Solna, Sweden

Locations

LIVA, Barn PMI, Karolinska Universitetssjukhuset Solna

Solna, , Sweden

Countries

Sweden

Central Contacts

Ida Engqvist, MD

Role: CONTACT

ida.engqvist@regionstockholm.se

+46(0)768455333

Eva Hedlund, MD, PhD

Role: CONTACT

eva.h.hedlund@regionstockholm.se

+46(0)707421285

Other Identifiers

2023-07493-01-V

Identifier Type: -

Identifier Source: org_study_id