Quality of Life (QOL)NCT06893458
Feeding Difficulties and Quality of Life in Children With Tracheal Cannula
An observational study of Quality of Life (QOL) and Tracheostomy, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
The over all goal of this observational study is to study if there is an association between the presence of feeding difficulties and self-assessed quality of life in children with tracheal cannula. The main questions it aims to answer are 1. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Quality of Life (QOL), Tracheostomy, Children in the Pediatric Intensive Care Unit or General Pediatric Care Unit Requiring a Central Venous Catheter
- How many people
- 80 participants
- Where
- 2 sitesSweden
- Study dates
- 17 Mar 2025to 17 Mar 2027
- 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 between jan 2025 and jan 2027. About 80 patients.
Inclusion Criteria: 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 between march 2025 and march 2027.
Exclusion criteria: Patients that can not undergo full evaluations/examinations will not be included.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Not yet recruiting
LIVA, Barn PMI, Karolinska Universitetssjukhuset Solna
Solna, Stockholm County, 17176
Ida Engqvist, Medical Doctor, +46(0)768455333, ida.engqvist@regionstockholm.se
Eva Hedlund, Medical Doctor PhD, +46(0)707421285, eva.h.hedlund@regionstockholm.se
- Recruiting
LIVA, Barn PMI, Karolinska Universitetssjukhuset, Solna, Sweden
Solna, Stockholm County, 17176
Eva Hedlund, Medical Doctor PhD, +46(0)707421285, eva.h.hedlund@regionstockholm.se
About this study
The over all goal of this observational study is to study if there is an association between the presence of feeding difficulties and self-assessed quality of life in children with tracheal cannula.
The main questions it aims to answer are
Read more
- What is the incidence of feeding difficulties in children with tracheostomy and what type of feeding difficulties affect these children?
- How do children with a tracheal tube and their parents assess their quality of life measured through PedsQL?
- Is there an association between the presence of feeding difficulties and self-assessed quality of life in children with tracheal cannula?
Quality of life will be assessed in an interview using the PedsQL instrument generic module 4.0. Swallowing difficulties will be assessed through evaluations based on The Montreal Children's Hospital Feeding Scale.
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 regular team assessments and linked to LIVA is a multidisciplinary team consisting of paediatricians, ear-nose-throat specialists, paediatric anaesthesiologists, nurses, physiotherapists, dietitians, speech therapists, counsellors, and play therapists.
Studies indicate that feeding difficulties in children with tracheostomies are common and many have enteral feeding entirely or partially through gastrostomies. Our understanding regarding the types of feeding difficulties that these children experience and the potential causes and consequences however are limited. Studies have shown that both children and parents of children with tracheostomies rate their quality of life far lower than other groups of children with severe chronic diseases. Existing studies however are small involving only 20-25 subjects and studies of the quality of life of tracheostomized children in Sweden and the factors that may determine quality of life is lacking. A study in children with esophageal atresia indicate that the ability to taste food in the mouth is related to increased self assessed quality of life. The association between swallowing difficulties and quality of life in children with tracheostomy has to the best of our knowledge not been investigated before.
Main objective:
To investigate the quality of life in children with tracheostomy and their caregivers and identify the aspects determining it. Feeding difficulties will be studied specifically to investigate if there is an association between the ability to feed orally and self-assessed quality of life.
Research questions:
Primary: Is there an association between the presence of feeding difficulties and self-assessed quality of life in children with tracheal cannula? Secondary: How do children with a tracheal tube and their parents assess their quality of life measured through PedsQL? Which factors affect the quality of life in children with a tracheostomy?
Method: This is a prospective observational study. The 80 children currently undergoing regular follow-up at LIVA will be eligible for inclusion. Quality of life assessment by both children and parents is conducted using the PedsQL instrument, generic module 4.0. This validated tool is a questionnaire with 23 questions covering four domains: health/activities, emotions, social functioning, and school/daycare. Swallowing difficulties are assessed through evaluations based on The Montreal Children's Hospital Feeding Scale, a validated tool used to assess and monitor the feeding abilities and behaviors of infants and young children. Each assessment takes approximately 10min and will take place within the framework of the multidisciplinary team visits that the children associated with LIVA participate in.
Measures of quality of life are compared with data from other populations in the PedsQL database and related to the scores regarding feeding difficulties derived from the Montreal Feeding Scale.
Ethical approval has been obtained, ref. no 2023-07493-01.
- Conditions
- Quality of Life (QOL), Tracheostomy, Children in the Pediatric Intensive Care Unit or General Pediatric Care Unit Requiring a Central Venous Catheter, Feeding Difficulties, Swallowing Difficulties, Caregiver Quality of Life
- Keywords
- pediatric quality of life, caregiver quality of life, swallowing related quality of life, feeding difficulties, pediatric tracheostomy
- Medical subject headings
- Deglutition Disorders
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.
Feeding difficulties in Children with Tracheostomy
Feeding difficulties are assessed based on The Montreal Children's Hospital Feeding Scale, a validated tool used to assess and monitor the feeding abilities and behaviors of infants and young children.
Measured: 2 years
Quality of Life in children with Tracheostomy
Quality of life assessment by children with tracheostomy and their parents is conducted using the PedsQL instrument, generic module 4.0. This validated tool is a questionnaire with 23 questions covering four domains: health/activities, emotions, social functioning, and school/daycare.
Measured: 2 years
Secondary outcomes (1)
Association between Quality of life and presens of feeding difficulties
Measures of Quality of Life measures through PedsQl are related to the presens of feeding difficulty measured through the Montreal Childrens Hospital Feeding Scale.
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 posted25 Mar 2025
- Study start17 Mar 2025
- Primary completion17 Mar 2027 (estimated)
- Study completion17 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Quality of Life (QOL)Studies 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
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Ida Engqvist, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893458
- Sponsor's protocol ID
- 2023-07493-01-IV
- Other IDs
- 2023
- Status last verified
- Feb 2026
- First submitted
- 18 Mar 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Raynor EM, Wohl D. Tracheostomy-Related Swallowing Issues in Children. Otolaryngol Clin North Am. 2024 Aug;57(4):649-655. doi: 10.1016/j.otc.2024.02.017. Epub 2024 Mar 19.
PubMed 38508881Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
PubMed 11468499Ramsay M, Martel C, Porporino M, Zygmuntowicz C. The Montreal Children's Hospital Feeding Scale: A brief bilingual screening tool for identifying feeding problems. Paediatr Child Health. 2011 Mar;16(3):147-e17. doi: 10.1093/pch/16.3.147.
PubMed 22379377Varni JW, Limbers CA, Burwinkle TM. Impaired health-related quality of life in children and adolescents with chronic conditions: a comparative analysis of 10 disease clusters and 33 disease categories/severities utilizing the PedsQL 4.0 Generic Core Scales. Health Qual Life Outcomes. 2007 Jul 16;5:43. doi: 10.1186/1477-7525-5-43.
PubMed 17634123Bergmann S, Ritz LA, Widenmann-Grolig A, Jechalke S, von Schweinitz D, Hubertus J, Lurz E. Swallowing-related quality of life in children with oesophageal atresia: a national cohort study. Eur J Pediatr. 2023 Jan;182(1):275-283. doi: 10.1007/s00431-022-04677-4. Epub 2022 Nov 4.
PubMed 36331620Pullens B, Streppel M. Swallowing problems in children with a tracheostomy. Semin Pediatr Surg. 2021 Jun;30(3):151053. doi: 10.1016/j.sempedsurg.2021.151053. Epub 2021 May 21.
PubMed 34172203Henningfeld J, Lang C, Erato G, Silverman AH, Goday PS. Feeding Disorders in Children With Tracheostomy Tubes. Nutr Clin Pract. 2021 Jun;36(3):689-695. doi: 10.1002/ncp.10551. Epub 2020 Jul 23.
PubMed 32700397
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feeding Difficulties and Quality of Life in Children With Tracheal Cannula
- ClinicalTrials.gov ID
- NCT06893458
- Acronym / sponsor ID
- 2023-07493-01-IV
- Conditions
- Quality of Life (QOL), Tracheostomy, Children in the Pediatric Intensive Care Unit or General Pediatric Care Unit Requiring a Central Venous Catheter, Feeding Difficulties, Swallowing Difficulties, Caregiver Quality of Life
- Keywords
- pediatric quality of life, caregiver quality of life, swallowing related quality of life, feeding difficulties, pediatric tracheostomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 17 Mar 2027 (estimated)
- Study completion
- 17 Mar 2027 (estimated)
- First posted
- 25 Mar 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 over all goal of this observational study is to study if there is an association between the presence of feeding difficulties and self-assessed quality of life in children with tracheal cannula.
The main questions it aims to answer are
- What is the incidence of feeding difficulties in children with tracheostomy and what type of feeding difficulties affect these children?
- How do children with a tracheal tube and their parents assess their quality of life measured through PedsQL?
- Is there an association between the presence of feeding difficulties and self-assessed quality of life in children with tracheal cannula?
Quality of life will be assessed in an interview using the PedsQL instrument generic module 4.0. Swallowing difficulties will be assessed through evaluations based on The Montreal Children's Hospital Feeding Scale.
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 regular team assessments and linked to LIVA is a multidisciplinary team consisting of paediatricians, ear-nose-throat specialists, paediatric anaesthesiologists, nurses, physiotherapists, dietitians, speech therapists, counsellors, and play therapists.
Studies indicate that feeding difficulties in children with tracheostomies are common and many have enteral feeding entirely or partially through gastrostomies. Our understanding regarding the types of feeding difficulties that these children experience and the potential causes and consequences however are limited. Studies have shown that both children and parents of children with tracheostomies rate their quality of life far lower than other groups of children with severe chronic diseases. Existing studies however are small involving only 20-25 subjects and studies of the quality of life of tracheostomized children in Sweden and the factors that may determine quality of life is lacking. A study in children with esophageal atresia indicate that the ability to taste food in the mouth is related to increased self assessed quality of life. The association between swallowing difficulties and quality of life in children with tracheostomy has to the best of our knowledge not been investigated before.
Main objective:
To investigate the quality of life in children with tracheostomy and their caregivers and identify the aspects determining it. Feeding difficulties will be studied specifically to investigate if there is an association between the ability to feed orally and self-assessed quality of life.
Research questions:
Primary: Is there an association between the presence of feeding difficulties and self-assessed quality of life in children with tracheal cannula? Secondary: How do children with a tracheal tube and their parents assess their quality of life measured through PedsQL? Which factors affect the quality of life in children with a tracheostomy?
Method: This is a prospective observational study. The 80 children currently undergoing regular follow-up at LIVA will be eligible for inclusion. Quality of life assessment by both children and parents is conducted using the PedsQL instrument, generic module 4.0. This validated tool is a questionnaire with 23 questions covering four domains: health/activities, emotions, social functioning, and school/daycare. Swallowing difficulties are assessed through evaluations based on The Montreal Children's Hospital Feeding Scale, a validated tool used to assess and monitor the feeding abilities and behaviors of infants and young children. Each assessment takes approximately 10min and will take place within the framework of the multidisciplinary team visits that the children associated with LIVA participate in.
Measures of quality of life are compared with data from other populations in the PedsQL database and related to the scores regarding feeding difficulties derived from the Montreal Feeding Scale.
Ethical approval has been obtained, ref. no 2023-07493-01.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- 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 between jan 2025 and jan 2027. About 80 patients.
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
Feeding difficulties in Children with Tracheostomy
Time frame: 2 years
Feeding difficulties are assessed based on The Montreal Children's Hospital Feeding Scale, a validated tool used to assess and monitor the feeding abilities and behaviors of infants and young children.
Quality of Life in children with Tracheostomy
Time frame: 2 years
Quality of life assessment by children with tracheostomy and their parents is conducted using the PedsQL instrument, generic module 4.0. This validated tool is a questionnaire with 23 questions covering four domains: health/activities, emotions, social functioning, and school/daycare.
1 secondary outcome
Association between Quality of life and presens of feeding difficulties
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 13 Feb 2026.
- Background: PubMed 38508881Raynor EM, Wohl D. Tracheostomy-Related Swallowing Issues in Children. Otolaryngol Clin North Am. 2024 Aug;57(4):649-655. doi: 10.1016/j.otc.2024.02.017. Epub 2024 Mar 19.
- Background: PubMed 11468499Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
- Background: PubMed 22379377Ramsay M, Martel C, Porporino M, Zygmuntowicz C. The Montreal Children's Hospital Feeding Scale: A brief bilingual screening tool for identifying feeding problems. Paediatr Child Health. 2011 Mar;16(3):147-e17. doi: 10.1093/pch/16.3.147.
- Background: PubMed 17634123Varni JW, Limbers CA, Burwinkle TM. Impaired health-related quality of life in children and adolescents with chronic conditions: a comparative analysis of 10 disease clusters and 33 disease categories/severities utilizing the PedsQL 4.0 Generic Core Scales. Health Qual Life Outcomes. 2007 Jul 16;5:43. doi: 10.1186/1477-7525-5-43.
- Background: PubMed 36331620Bergmann S, Ritz LA, Widenmann-Grolig A, Jechalke S, von Schweinitz D, Hubertus J, Lurz E. Swallowing-related quality of life in children with oesophageal atresia: a national cohort study. Eur J Pediatr. 2023 Jan;182(1):275-283. doi: 10.1007/s00431-022-04677-4. Epub 2022 Nov 4.
- Background: PubMed 34172203Pullens B, Streppel M. Swallowing problems in children with a tracheostomy. Semin Pediatr Surg. 2021 Jun;30(3):151053. doi: 10.1016/j.sempedsurg.2021.151053. Epub 2021 May 21.
- Background: PubMed 32700397Henningfeld J, Lang C, Erato G, Silverman AH, Goday PS. Feeding Disorders in Children With Tracheostomy Tubes. Nutr Clin Pract. 2021 Jun;36(3):689-695. doi: 10.1002/ncp.10551. Epub 2020 Jul 23.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life (QOL) and Tracheostomy, run by Karolinska Institutet at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 13 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 2 sites 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 Engqvist, Medical Doctor (+46 (+)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?
Feeding difficulties in Children with Tracheostomy (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?
On the ClinicalTrials.gov record for NCT06893458, which also lists 7 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 13 Feb 2026.