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

NCT06906263 | Recruiting

• 1 other identifier: 2023-07493-01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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 several times during the study period.

Conditions

Anesthesia Complication; Tracheostomy Complications; Children Receiving General Anesthesia

Keywords

Tracheostomy; Pediatric; Anesthesia complication; general anesthesia

Outcome Measures

Primary Outcomes (1)

• severe anaesthesiologic complications

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

  Perioperative

Secondary Outcomes (1)

• Association between severe anaesthesiologic complications and patient related factors

  Perioperative

Study Arms (1)

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.

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

All children below 18yrs with tracheostomy undergoing follow-up with surveillance airway endoscopy in general anesthesia at the Long Term Intensive Care unit (LIVA) at Karolinska University Hospital in Stockholm Sweden will be studied. This includes a majority of the children with tracheostomy in Sweden.

You may not qualify if:

• Patients will be excluded from the study if the airway endoscopy is a non-elective emergency procedure.
• Patients undergoing concurrent major surgery during the same session will be included in the study but excluded from analysis of postoperative symptoms (secondary outcome measure). This is because postoperative well-being cannot be reliably attributed to the airway endoscopy alone when major surgery is performed simultaneously.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Pediatric Perioperative Medicine and Intensive Care

Solna, 171 76, Sweden

RECRUITING

Related Publications (3)

• Al Bahri K, Liu CC. Surveillance endoscopy in pediatric tracheostomy: A systematic review. Int J Pediatr Otorhinolaryngol. 2021 Jan;140:110533. doi: 10.1016/j.ijporl.2020.110533. Epub 2020 Dec 1.

  PMID: 33296833 BACKGROUND

• Habre W, Disma N, Virag K, Becke K, Hansen TG, Johr M, Leva B, Morton NS, Vermeulen PM, Zielinska M, Boda K, Veyckemans F; APRICOT Group of the European Society of Anaesthesiology Clinical Trial Network. Incidence of severe critical events in paediatric anaesthesia (APRICOT): a prospective multicentre observational study in 261 hospitals in Europe. Lancet Respir Med. 2017 May;5(5):412-425. doi: 10.1016/S2213-2600(17)30116-9. Epub 2017 Mar 28.

  PMID: 28363725 BACKGROUND

• Liu CC, Soares JJ, Elder L, Hill L, Abts M, Bonilla-Velez J, Dahl JP, Johnson KE, Ong T, Striegl AM, Whitlock K, Parikh SR. Surveillance endoscopy after tracheostomy placement in children: Findings and interventions. Laryngoscope. 2020 May;130(5):1327-1332. doi: 10.1002/lary.28247. Epub 2019 Oct 31.

  PMID: 31670383 BACKGROUND

Central Study Contacts

Ida Engqvist, M.D

CONTACT

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

Andreas Andersson, Associate Professor

CONTACT

+46 (0)704997886

Study Design

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

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 2, 2025
• Study Start: March 31, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

SE (1)