Anesthesia ComplicationNCT06906263
Complications Related to the Anaesthesia During Airway Endoscopy in Children With Tracheostomy.
An observational study of Anesthesia Complication and Tracheostomy Complications, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Anesthesia Complication, Tracheostomy Complications, Children Receiving General Anesthesia
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- 31 Mar 2025to 31 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
None listed.
Who cannot join
- 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.
- The same patient may be eligible for inclusion at multiple time points during the inclusion period if subject to subsequent airway endoscopies that meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Andreas Andersson, Associate Professor contact
Sweden1 site, 1 recruiting
- Recruiting
Pediatric Perioperative Medicine and Intensive Care
Solna, 171 76
Eva Hedlund, M.D. Ph.D, +46 (0)707421285, eva.h.hedlund@regionstockholm.se
Ida Engqvist, M.D, +46 (0)768455333, ida.engqvist@regionstockholm.se
About this study
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.
Read more
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.
Read the detailed description
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 approximately 100 investigations have been performed or the 3 year investigation period has ended. Participants may be included several times during the study period. 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
- Anesthesia Complication, Tracheostomy Complications, Children Receiving General Anesthesia
- Keywords
- Tracheostomy, Pediatric, Anesthesia complication, general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
severe anaesthesiologic complications
The incidence of severe anaesthesiologic complications in children with tracheostomy undergoing surveillance airway endoscopy.
Measured: Perioperative
Secondary outcomes (1)
Association between severe anaesthesiologic complications and patient related factors
The association between severe anaesthesiologic complications and patient related factors: age at tracheostomy, age at surveillance endoscopy, ventilatory dependence, current and previously diagnosed tracheostomy related airway complications.
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start31 Mar 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anesthesia ComplicationStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ida Engqvist, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906263
- Sponsor's protocol ID
- 2023-07493-01
- Other IDs
- 2023
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33296833Habre 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.
PubMed 28363725Liu 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.
PubMed 31670383
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complications Related to the Anaesthesia During Airway Endoscopy in Children With Tracheostomy.
- ClinicalTrials.gov ID
- NCT06906263
- Acronym / sponsor ID
- 2023-07493-01
- Conditions
- Anesthesia Complication, Tracheostomy Complications, Children Receiving General Anesthesia
- Keywords
- Tracheostomy, Pediatric, Anesthesia complication, general anesthesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 approximately 100 investigations have been performed or the 3 year investigation period has ended. Participants may be included several times during the study period. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- 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.
- The same patient may be eligible for inclusion at multiple time points during the inclusion period if subject to subsequent airway endoscopies that meet the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
severe anaesthesiologic complications
Time frame: Perioperative
The incidence of severe anaesthesiologic complications in children with tracheostomy undergoing surveillance airway endoscopy.
1 secondary outcome
Association between severe anaesthesiologic complications and patient related factors
Time frame: Perioperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Background: PubMed 33296833Al 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.
- Background: PubMed 28363725Habre 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.
- Background: PubMed 31670383Liu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andreas Andersson, Associate Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia Complication and Tracheostomy Complications, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ida Engqvist, M.D (+46 (0) 768455333, ida.engqvist@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severe anaesthesiologic complications (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06906263, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.