SurveillanceNCT07121517
"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?"
An observational study of Surveillance and Endoscopy, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Surveillance, Endoscopy, Tracheostomy Complication
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2025to 31 Aug 2027
- How long will I take part?
- 2 Years
- 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: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
LIVA, Barn PMI, Karolinska Universitetssjukhuset Solna
Solna, 17176
About this study
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.
Read more
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:
- To what extent are tracheostomy-related complications in children asymptomatic when detected through surveillance airway endoscopy?
- 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.
Read the 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
- To what extent are tracheostomy-related complications in children asymptomatic when detected through surveillance airway endoscopy?
- 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
- Keywords
- surveillance, endoscopy, pediatric, intensive care unit, tracheostomy complication
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 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years
Secondary outcomes (3)
Proportion of patients that was diagnosed with at least one serious tracheostomy related complication during the study period.
Tracheostomy related complications are identified through suveillance airway endoscopy. Serious tracheostomy related complications incluce suprastomal granuloma, suprastomal prolapse, tip granuloma, tip erosion or other stoma pathology with urgent need for intervention.
Measured: 2 years
Proportion of surveillance airway endoscopies identifying 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.
Measured: 2 years
Proportion of surveillance airway endoscopies identifying a serious tracheostomy related airway complication without associated symptoms reported by pediatrician 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 Sep 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurveillanceStudies 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
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Ida Engqvist, Karolinska Institutet
- Investigators
- Ida Engqvist, MD, Principal investigator, LIVA, Barn PMI, Karolinska Universitetssjukhuset, Solna, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121517
- Sponsor's protocol ID
- 2023-07493-01-V
- Other IDs
- 2023
- Status last verified
- Feb 2026
- First submitted
- 6 Aug 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "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?"
- ClinicalTrials.gov ID
- NCT07121517
- Acronym / sponsor ID
- 2023-07493-01-V
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 13 Aug 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.
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:
- To what extent are tracheostomy-related complications in children asymptomatic when detected through surveillance airway endoscopy?
- 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
- To what extent are tracheostomy-related complications in children asymptomatic when detected through surveillance airway endoscopy?
- 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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
Proportion of patients who are diagnosed with a serious tracheostomy related airway complication, without associated symptoms reported by caregiver prior to airway endoscopy.
Time frame: 2 years
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.
Proportion of patients who are diagnosed with a serious tracheostomy related airway complication, without associated symptoms reported by a paediatrician prior to airway endoscopy.
Time frame: 2 years
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.
3 secondary outcomes
Proportion of patients that was diagnosed with at least one serious tracheostomy related complication during the study period.
Time frame: 2 years
Proportion of surveillance airway endoscopies identifying a serious tracheostomy related airway complication without associated symptoms reported by caregiver prior to airway endoscopy.
Time frame: 2 years
Proportion of surveillance airway endoscopies identifying a serious tracheostomy related airway complication without associated symptoms reported by pediatrician prior to airway endoscopy .
Time frame: 2 years
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 17 Feb 2026.
- 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.
Ida Engqvist, MD principal investigator
LIVA, Barn PMI, Karolinska Universitetssjukhuset, Solna, Sweden
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 Surveillance and Endoscopy, 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 1 inclusion and 1 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 17 Feb 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, MD (+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?
Proportion of patients who are diagnosed with a serious tracheostomy related airway complication, without associated symptoms reported by caregiver prior to airway endoscopy. (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2026.