Complications Related to the Anaesthesia During Airway Endoscopy in Children with Tracheostomy.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-31

Study Completion Date

2027-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this observational study is to investigate the incidence of severe anaesthesiologic complications during anaesthesia in children with tracheostomy undergoing surveillance airway endoscopy. The main question it aims to answer is how common severe anaesteshiologic complications are in these patients and investigate if there is an association between severe anaesthesiologic complications and patient related factors.

Primary outcome: The incidence of severe anaesthesiologic complications in children with tracheostomy undergoing surveillance airway endoscopy.

Secondary outcome: The association between severe anaesthesiologic complications and patient related factors: age at tracheostomy, age at surveillance endoscopy, ventilator dependence, current and previously diagnosed tracheostomy related airway complications.

All children under 18 yrs. of age with a tracheostomy accepted for general anaesthesia undergoing surveillance airway endoscopy at the Long term Intensive Care unit at Karolinska University Hospital Stockholm Sweden will be eligable for inclusion. The anaesthesia will be conducted according to current practise and complications will recorded by the anaesthesiologist in charge. Participants may only be included once.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

"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

Surveillance Endoscopy Tracheostomy Complication +3 more

NOT_YET_RECRUITING

Feeding Difficulties and Quality of Life in Children with Tracheal Cannula

NCT06893458

Quality of Life (QOL) Tracheostomy Children in the Pediatric Intensive Care Unit or General Pediatric Care Unit Requiring a Central Venous Catheter +3 more

NOT_YET_RECRUITING

Challenges and Management of Post-intubation Tracheal Stenosis

NCT06061380

Tracheal Stenosis

COMPLETED

Endoscopic Evaluation of the Paediatric Airway After Prior Prolonged (>24 h) Tracheal Intubation

NCT02350933

Intubation Endoscopy

COMPLETED NA

Routine Use of FIBERoptic Bronchoscopic Guidance in Percutaneous TRACHeostomy

NCT04265625

Complications

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Background:

Children with airway obstruction due to inborn malformations or trauma, or who have a chronic need for respiratory support due to lung- or neuromuscular diseases, may require a tracheostomy. A tracheostomy is a surgical opening of the trachea at the front of the neck to create an artificial airway, maintained with a tracheostomy tube. The Long-term Intensive Care Unit (LIVA) is a unit within Paediatric Perioperative Medicine and Intensive Care (BPMI) at Karolinska University Hospital. Since 1998, its primary task has been to care for children with tracheostomies from a large part of the country and it is the only unit of its kind in Scandinavia.

LIVA's follow-up of children with tracheostomies includes 1-2 surveillance airway endoscopies under anaesthesia per year. The endoscopies aim to early identify airway complications related to the tracheostomy tube. Complications, such as granulomas, infections, or bleeding, are often asymptomatic, and potentially lethal. There is no international nor national consensus regarding how often surveillance endoscopies should be performed. The possibility of individualizing the surveillance program based on risk factors has not been explored. Every anaesthesia carries a potential risk for the child. The incidence of complications related to the anaesthesia in children with tracheostomy undergoing airway endoscopy has not yet been investigated.

In this study the investigator aim at assessing the incidence of anaesthesia-related complications during the surveillance airway endoscopies. Understanding the anaesthesiologic risk associated with the endoscopies is important in weighing risk versus benefit with the current surveillance airway endoscopy program.

Main objective: To investigate the incidence of anaesthesiologic complications in children undergoing airway endoscopy as part of the surveillance program for children with tracheostomy.

Research outcomes:

Primary outcome: What is the incidence of severe anaesthesiologic complications in children with tracheostomy undergoing surveillance airway endoscopy? Secondary outcome: Is the risk for anaesthesia complications associated with patient related factors such as age, comorbidity and indication for tracheostomy?

Method: This is a prospective observational study. All children with tracheostomy undergoing follow-up through LIVA scheduled to undergo a surveillance endoscopy will be eligible for inclusion continued until 80 investigations have been performed or the 2 year investigation period has ended. Participants may only be included once. The anaesthesia is conducted according to current practice. Anaesthesia-related complications are recorded by the anaesthesiologist in charge through a standardized protocol including occurrences of hypoxemia, bronchospasm, aspiration, severe bradycardia and hypothermia, during anaesthesia and in the immediate postoperative period. Demographic data and information regarding risk factors with regards to anaesthesiologic complications are collected from patient charts. Ethical approval has been obtained, ref. no2023-07493-01.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthesia Complication Tracheostomy Complications Children Receiving General Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Children below 18yrs with tracheostomy undergoing follow-up with surveillance airway endoscopy

The children with tracheostomy undergoing follow-up with surveillance airway endoscopy under general anasthesia through the Long term intensive care unit (LIVA) at Karolinska Hospital Stockholm Sweden between jan 2025-dec 2026.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

All patients

1. under the age of 18yrs
2. with tracheostomy
3. undergoing surveillance airway endoscopy
4. approved for anesthesia

will be included once within the time frame of the study (2years).

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No