Tracheostomy PatientsON TRACHNCT07769021
Tracheostomy Practice in Adult Intensive Care Units
An observational study of Tracheostomy Patients and Tracheostomy Decannulation, run by Royal College of Surgeons, Ireland at 13 sites in 8 countries.
Trial summary
ON TRACH is an international, multicentre, observational study with the aim of characterising the timing and practice of tracheostomy insertion, management, weaning and longer-term outcomes of these patients, in intensive care units internationally. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy Patients, Tracheostomy Decannulation, Intensive Care (ICU)
- How many people
- 2,500 participants
- Where
- 13 sitesin 8 countries
- Study dates
- 2 Nov 2026to Mar 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients aged 18 years and older admitted in the intensive care unit after commencement of the enrolment period, and that are in receipt of invasive ventilator support, will be screened daily until ICU discharge or death. Those that undergo tracheostomy insertion during critical care admission will be included in the study.
Who may be able to join
- Greater than 18 years of age
- Tracheostomy insertion during critical care admission
Who cannot join
- Tracheostomy prior to critical care admission
- Elective tracheostomy insertion for head and neck pathology
- Tracheostomy insertion for emergency surgical management of airway obstruction
- Mini tracheostomy insertion only
Trial locations and contacts
13 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
Michelle Smyth, BSc contact
13 sites in 8 countries
Ireland3 sites
Beaumont Hospital
Dublin
Michelle Smyth, +353868823764, michellesmyth@rcsi.ie
Ger Curley
Mater Misericordiae University Hospital Dublin
Dublin
Aisling Mc Mahon, +353861091104, aislingmcmahon@mater.ie
Stephen Murphy
Galway University Hospital
Galway
John Laffey, MD DSc, +353 91 544315, jlaffey@universityofgalway.ie
John Laffey, MD Dsc
Italy3 sites
Ospedale Policlinico San Martino Genoa
Genova
Denise Battaglini, PhD, +39 010 5551, battaglini.denise@gmail.com
Denise Battaglini, PhD
University of Naples Frederico II
Naples
Maria Vargas, PhD, +39 081 253 1111, vargas.maria82@gmail.com
Maria Vargas, PhD
University Hospital San Luigi Gonzaga Turin
Torino
Vincenzo Russotto, MD, +39 011 90261
Vincenzo Russotto, MD
United States2 sites
University of Michigan Health Ann Arbor
Ann Arbor, Michigan, 48109
Michael Brenner, MD, 734-936-4000, mbren@med.umich.edu
Michael Brenner, MD
Beth Israel Medical Centre
Boston, Massachusetts, 02215
Elisabeth Riviello, MD, 617-667-7000, eriviell@bidmc.havard.edu
Elisabeth Riviello, MD
Brazil1 site
Nereu Ramos Hospital
Florianópolis
Israel Maia, MD, +48 3216-9300, israels.maia@gmail.com
Israel Maia, MD
Canada1 site
Toronto General Hospital
Toronto
Matteo Parotto, PhD, 416-340-4800, matteo.parotto@uhn.ca
Matteo Parotto, PhD
India1 site
Tata Memorial Hospital
Mumbai
Shiela Myatra, MD, +91 22 2417 7000, shiela150@hotmail.com
Shiela Myatra, MD
Switzerland1 site
University Hospital of Lausanne
Lausanne
Lise Piquilloud Imboden, PhD, +41 21 314 11 11, lise.piquilloud@chuv.ch
Lise Piquilloud Imboden, PhD
United Kingdom1 site
Manchester University Hospital
Manchester
Brendan Mc Grath, PhD, +44 161 276 1234, brendan.mcgrath@manchester.ac.uk
Brendan Mc Grath, PhD
About this study
Official title: Observational iNternational Study of TRACHeostomy Practice in Adult Intensive Care Units - ON TRACH
ON TRACH is an international, multicentre, observational study with the aim of characterising the timing and practice of tracheostomy insertion, management, weaning and longer-term outcomes of these patients, in intensive care units internationally. Participating intensive care units (ICU) will recruit all consecutive patients undergoing tracheostomy insertion over a 12 week period, aiming for broad global representation. This will allow identification of variation in care of patients with a tracheostomy in the intensive care and it's origin, to drive improvement and enhance safety and outcomes for patients with a tracheostomy in the future.
Read the detailed description
Care of the patient with a tracheostomy is a core element of critical care practice. Around 20% of patients admitted to an intensive care unit (ICU) undergo tracheostomy insertion during their stay, typically in the context of prolonged mechanical ventilation and complex rehabilitation needs. Despite its frequent use and ongoing quality improvement initiatives, considerable variation in practice continues to exist and many questions with regards to tracheostomy timing, insertion, management and longer-term outcomes remain.
Variation exists not only because of patient characteristics, but also from an organisational perspective with diversity in hospital settings, system demands and governance structures. These inconsistencies lead to deficiencies in care and avoidable harm, increased morbidity and mortality.
This is an international multicentre prospective observational study to comprehensively characterise current tracheostomy practice. The study aims to describe the indications, timing, techniques, and management of tracheostomy insertion and care; to evaluate patient-centred outcomes and procedure-related adverse events; and to explore the organisational structures and models of care supporting tracheostomised patients in the ICU and beyond. This will allow us to identify variation in care, it's origin, drive improvement and enhance safety and outcomes for patients with a tracheostomy in the future.
- Keywords
- tracheostomy, decannulation, intensive care, prolonged mechanical ventilation, tracheostomy weaning, tracheostomy outcomes
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 |
|---|---|---|
| Critical care patients with a tracheostomy | Participants will include patients 18 years and older, admitted to the intensive care, who undergo tracheostomy insertion as part of their critical care admission. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful tracheostomy decannulation
The proportion of patients successfully decannulated from tracheostomy, censored at hospital discharge or 90 days, whichever comes first.
Measured: 90 days
Secondary outcomes (7)
Time to decannulation
Time to successful decannulation censored at hospital discharge or 90 days, whichever comes first.
Measured: 90 days
Mortality
Measured: 90 days
Hospital utilization metrics
Duration of mechanical ventilation, ICU and hospital length of stay
Measured: 90 days
Return to vocalisation
Measured by time in days to placement of a speaking valve
Measured: 90 days
Return to oral intake
Measured using the Functional Oral Intake Scale (FOIS) which ranges from level 1 to 7, where level 1 is no oral intake and level 7 is full oral intake with no restrictions.
Measured: 90 days
Return to mobilisation
Measured using the Intensive Care Mobility Scale which ranges from 1 to 10 with 10 indicating a greater degree of mobility.
Measured: 90 days
Health related quality of life
Quality of life measured using the EuroQol five-dimensional questionnaire (EQ-5D-5L) with a lower score indicating a better quality of life.
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start2 Nov 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Tracheostomy PatientsStudies of the same condition, open and under way.
- 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
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769021
- Sponsor's protocol ID
- 26/54
- Other IDs
- ESICM 2026 Lachmann Grant
- Acronym
- ON TRACH
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abe T, Madotto F, Pham T, Nagata I, Uchida M, Tamiya N, Kurahashi K, Bellani G, Laffey JG; LUNG-SAFE Investigators and the ESICM Trials Group. Epidemiology and patterns of tracheostomy practice in patients with acute respiratory distress syndrome in ICUs across 50 countries. Crit Care. 2018 Aug 17;22(1):195. doi: 10.1186/s13054-018-2126-6.
PubMed 30115127Premraj L, Camarda C, White N, Godoy DA, Cuthbertson BH, Rocco PRM, Pelosi P, Robba C, Suarez JI, Cho SM, Battaglini D. Tracheostomy timing and outcome in critically ill patients with stroke: a meta-analysis and meta-regression. Crit Care. 2023 Apr 1;27(1):132. doi: 10.1186/s13054-023-04417-6.
PubMed 37005666Selekwa M, Maina I, Yeh T, Nkya A, Ncogoza I, Nuss RC, Mushi BP, Haddadi S, Van Loon K, Mbaga E, Massawe W, Roberson DW, Dharsee N, Musimu B, Xu MJ. Tracheostomy care quality improvement in low- and middle-income countries: A scoping review. PLOS Glob Public Health. 2023 Nov 9;3(11):e0002294. doi: 10.1371/journal.pgph.0002294. eCollection 2023.
PubMed 37943736Vargas M, Sutherasan Y, Antonelli M, Brunetti I, Corcione A, Laffey JG, Putensen C, Servillo G, Pelosi P. Tracheostomy procedures in the intensive care unit: an international survey. Crit Care. 2015 Aug 13;19(1):291. doi: 10.1186/s13054-015-1013-7.
PubMed 26271742Merola R, Vargas M, Sanfilippo F, Vergano M, Mistraletti G, Vetrugno L, De Pascale G, Bignami EG, Servillo G, Battaglini D. Tracheostomy Practice in the Italian Intensive Care Units: A Point-Prevalence Survey. Medicina (Kaunas). 2025 Jan 7;61(1):87. doi: 10.3390/medicina61010087.
PubMed 39859070Polok K, Fronczek J, van Heerden PV, Flaatten H, Guidet B, De Lange DW, Fjolner J, Leaver S, Beil M, Sviri S, Bruno RR, Wernly B, Artigas A, Pinto BB, Schefold JC, Studzinska D, Joannidis M, Oeyen S, Marsh B, Andersen FH, Moreno R, Cecconi M, Jung C, Szczeklik W; COVIP study group. Association between tracheostomy timing and outcomes for older critically ill COVID-19 patients: prospective observational study in European intensive care units. Br J Anaesth. 2022 Mar;128(3):482-490. doi: 10.1016/j.bja.2021.11.027. Epub 2021 Nov 29.
PubMed 34955167Zaga CJ, Milliren CE, McGrath BA, Yang CJ, Schiff BA, Warrillow SJ, Henningfeld JK, Gregson PA, Bedwell JR, Beaudet KM, Brenner MJ, Pandian V. Predictors of Decannulation Success in Tracheostomy: A 10-Year Analysis of the Global Tracheostomy Collaborative Database. Otolaryngol Head Neck Surg. 2025 Nov;173(5):1138-1148. doi: 10.1002/ohn.70013. Epub 2025 Sep 2.
PubMed 40891658Carton E, Fitzgerald E, Elebert R, Malone C, O'Brien S, Dunne A, Ni Muircheartaigh R, Phelan D. Changes in Multidisciplinary Tracheostomy Team Practice Over Time. Ir Med J. 2021 Sep 20;114(8):433.
PubMed 35863078Mikhaeil M, Bernard M, Currie J, Bolduc C, Radke J, Kranjc S, Meyer J. Improving weaning and liberation from mechanical ventilation for tracheostomy patients: a quality improvement initiative. BMJ Qual Saf. 2025 Jun 19;34(7):480-488. doi: 10.1136/bmjqs-2024-018324.
PubMed 40318863McGrath BA, Wallace S, Lynch J, Bonvento B, Coe B, Owen A, Firn M, Brenner MJ, Edwards E, Finch TL, Cameron T, Narula A, Roberson DW. Improving tracheostomy care in the United Kingdom: results of a guided quality improvement programme in 20 diverse hospitals. Br J Anaesth. 2020 Jul;125(1):e119-e129. doi: 10.1016/j.bja.2020.04.064. Epub 2020 May 31.
PubMed 32493580Brenner MJ, Davies EA, McGrath BA. Reducing variation in tracheostomy care can improve outcomes. Br J Anaesth. 2022 Apr;128(4):e282-e284. doi: 10.1016/j.bja.2022.01.008. Epub 2022 Feb 8. No abstract available.
PubMed 35144800Brenner MJ, Pandian V, Milliren CE, Graham DA, Zaga C, Morris LL, Bedwell JR, Das P, Zhu H, Lee Y Allen J, Peltz A, Chin K, Schiff BA, Randall DM, Swords C, French D, Ward E, Sweeney JM, Warrillow SJ, Arora A, Narula A, McGrath BA, Cameron TS, Roberson DW. Global Tracheostomy Collaborative: data-driven improvements in patient safety through multidisciplinary teamwork, standardisation, education, and patient partnership. Br J Anaesth. 2020 Jul;125(1):e104-e118. doi: 10.1016/j.bja.2020.04.054. Epub 2020 May 23.
PubMed 32456776Gentile MN, Irvine AD, King AM, Hembrom AS, Guruswamy KS, Palivela NE, Langton-Frost N, McElroy CR, Pandian V. Enhancing Communication in Critically Ill Patients with a Tracheostomy: A Systematic Review of Evidence-Based Interventions and Outcomes. Tracheostomy. 2024;1(1):26-41. doi: 10.62905/001c.115440. Epub 2024 Mar 31.
PubMed 39253605Damuth E, Mitchell JA, Bartock JL, Roberts BW, Trzeciak S. Long-term survival of critically ill patients treated with prolonged mechanical ventilation: a systematic review and meta-analysis. Lancet Respir Med. 2015 Jul;3(7):544-53. doi: 10.1016/S2213-2600(15)00150-2. Epub 2015 May 20.
PubMed 26003390Dempsey GA, Morton B, Hammell C, Williams LT, Tudur Smith C, Jones T. Long-Term Outcome Following Tracheostomy in Critical Care: A Systematic Review. Crit Care Med. 2016 Mar;44(3):617-28. doi: 10.1097/CCM.0000000000001382.
PubMed 26584197
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational iNternational Study of TRACHeostomy Practice in Adult Intensive Care Units - ON TRACH
- ClinicalTrials.gov ID
- NCT07769021
- Acronym / sponsor ID
- ON TRACH / 26/54
- Keywords
- tracheostomy, decannulation, intensive care, prolonged mechanical ventilation, tracheostomy weaning, tracheostomy outcomes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 17 Aug 2026 (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.
ON TRACH is an international, multicentre, observational study with the aim of characterising the timing and practice of tracheostomy insertion, management, weaning and longer-term outcomes of these patients, in intensive care units internationally. Participating intensive care units (ICU) will recruit all consecutive patients undergoing tracheostomy insertion over a 12 week period, aiming for broad global representation. This will allow identification of variation in care of patients with a tracheostomy in the intensive care and it's origin, to drive improvement and enhance safety and outcomes for patients with a tracheostomy in the future.
Detailed description
Care of the patient with a tracheostomy is a core element of critical care practice. Around 20% of patients admitted to an intensive care unit (ICU) undergo tracheostomy insertion during their stay, typically in the context of prolonged mechanical ventilation and complex rehabilitation needs. Despite its frequent use and ongoing quality improvement initiatives, considerable variation in practice continues to exist and many questions with regards to tracheostomy timing, insertion, management and longer-term outcomes remain.
Variation exists not only because of patient characteristics, but also from an organisational perspective with diversity in hospital settings, system demands and governance structures. These inconsistencies lead to deficiencies in care and avoidable harm, increased morbidity and mortality.
This is an international multicentre prospective observational study to comprehensively characterise current tracheostomy practice. The study aims to describe the indications, timing, techniques, and management of tracheostomy insertion and care; to evaluate patient-centred outcomes and procedure-related adverse events; and to explore the organisational structures and models of care supporting tracheostomised patients in the ICU and beyond. This will allow us to identify variation in care, it's origin, drive improvement and enhance safety and outcomes for patients with a tracheostomy in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critical care patients with a tracheostomy | – | –Participants will include patients 18 years and older, admitted to the intensive care, who undergo tracheostomy insertion as part of their critical care admission. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients aged 18 years and older admitted in the intensive care unit after commencement of the enrolment period, and that are in receipt of invasive ventilator support, will be screened daily until ICU discharge or death. Those that undergo tracheostomy insertion during critical care admission will be included in the study.
Key inclusion criteria (2 listed)
- Greater than 18 years of age
- Tracheostomy insertion during critical care admission
Key exclusion criteria (4 listed)
- Tracheostomy prior to critical care admission
- Elective tracheostomy insertion for head and neck pathology
- Tracheostomy insertion for emergency surgical management of airway obstruction
- Mini tracheostomy insertion only
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
Successful tracheostomy decannulation
Time frame: 90 days
The proportion of patients successfully decannulated from tracheostomy, censored at hospital discharge or 90 days, whichever comes first.
7 secondary outcomes
Time to decannulation
Time frame: 90 days
Mortality
Time frame: 90 days
Hospital utilization metrics
Time frame: 90 days
Return to vocalisation
Time frame: 90 days
Return to oral intake
Time frame: 90 days
Return to mobilisation
Time frame: 90 days
Health related quality of life
Time frame: 3, 6 and 12 months
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 Aug 2026.
- Background: PubMed 30115127Abe T, Madotto F, Pham T, Nagata I, Uchida M, Tamiya N, Kurahashi K, Bellani G, Laffey JG; LUNG-SAFE Investigators and the ESICM Trials Group. Epidemiology and patterns of tracheostomy practice in patients with acute respiratory distress syndrome in ICUs across 50 countries. Crit Care. 2018 Aug 17;22(1):195. doi: 10.1186/s13054-018-2126-6.
- Background: PubMed 37005666Premraj L, Camarda C, White N, Godoy DA, Cuthbertson BH, Rocco PRM, Pelosi P, Robba C, Suarez JI, Cho SM, Battaglini D. Tracheostomy timing and outcome in critically ill patients with stroke: a meta-analysis and meta-regression. Crit Care. 2023 Apr 1;27(1):132. doi: 10.1186/s13054-023-04417-6.
- Background: PubMed 37943736Selekwa M, Maina I, Yeh T, Nkya A, Ncogoza I, Nuss RC, Mushi BP, Haddadi S, Van Loon K, Mbaga E, Massawe W, Roberson DW, Dharsee N, Musimu B, Xu MJ. Tracheostomy care quality improvement in low- and middle-income countries: A scoping review. PLOS Glob Public Health. 2023 Nov 9;3(11):e0002294. doi: 10.1371/journal.pgph.0002294. eCollection 2023.
- Background: PubMed 26271742Vargas M, Sutherasan Y, Antonelli M, Brunetti I, Corcione A, Laffey JG, Putensen C, Servillo G, Pelosi P. Tracheostomy procedures in the intensive care unit: an international survey. Crit Care. 2015 Aug 13;19(1):291. doi: 10.1186/s13054-015-1013-7.
- Background: PubMed 39859070Merola R, Vargas M, Sanfilippo F, Vergano M, Mistraletti G, Vetrugno L, De Pascale G, Bignami EG, Servillo G, Battaglini D. Tracheostomy Practice in the Italian Intensive Care Units: A Point-Prevalence Survey. Medicina (Kaunas). 2025 Jan 7;61(1):87. doi: 10.3390/medicina61010087.
- Background: PubMed 34955167Polok K, Fronczek J, van Heerden PV, Flaatten H, Guidet B, De Lange DW, Fjolner J, Leaver S, Beil M, Sviri S, Bruno RR, Wernly B, Artigas A, Pinto BB, Schefold JC, Studzinska D, Joannidis M, Oeyen S, Marsh B, Andersen FH, Moreno R, Cecconi M, Jung C, Szczeklik W; COVIP study group. Association between tracheostomy timing and outcomes for older critically ill COVID-19 patients: prospective observational study in European intensive care units. Br J Anaesth. 2022 Mar;128(3):482-490. doi: 10.1016/j.bja.2021.11.027. Epub 2021 Nov 29.
- Background: PubMed 40891658Zaga CJ, Milliren CE, McGrath BA, Yang CJ, Schiff BA, Warrillow SJ, Henningfeld JK, Gregson PA, Bedwell JR, Beaudet KM, Brenner MJ, Pandian V. Predictors of Decannulation Success in Tracheostomy: A 10-Year Analysis of the Global Tracheostomy Collaborative Database. Otolaryngol Head Neck Surg. 2025 Nov;173(5):1138-1148. doi: 10.1002/ohn.70013. Epub 2025 Sep 2.
- Background: PubMed 35863078Carton E, Fitzgerald E, Elebert R, Malone C, O'Brien S, Dunne A, Ni Muircheartaigh R, Phelan D. Changes in Multidisciplinary Tracheostomy Team Practice Over Time. Ir Med J. 2021 Sep 20;114(8):433.
- Background: PubMed 40318863Mikhaeil M, Bernard M, Currie J, Bolduc C, Radke J, Kranjc S, Meyer J. Improving weaning and liberation from mechanical ventilation for tracheostomy patients: a quality improvement initiative. BMJ Qual Saf. 2025 Jun 19;34(7):480-488. doi: 10.1136/bmjqs-2024-018324.
- Background: PubMed 32493580McGrath BA, Wallace S, Lynch J, Bonvento B, Coe B, Owen A, Firn M, Brenner MJ, Edwards E, Finch TL, Cameron T, Narula A, Roberson DW. Improving tracheostomy care in the United Kingdom: results of a guided quality improvement programme in 20 diverse hospitals. Br J Anaesth. 2020 Jul;125(1):e119-e129. doi: 10.1016/j.bja.2020.04.064. Epub 2020 May 31.
- Background: PubMed 35144800Brenner MJ, Davies EA, McGrath BA. Reducing variation in tracheostomy care can improve outcomes. Br J Anaesth. 2022 Apr;128(4):e282-e284. doi: 10.1016/j.bja.2022.01.008. Epub 2022 Feb 8. No abstract available.
- Background: PubMed 32456776Brenner MJ, Pandian V, Milliren CE, Graham DA, Zaga C, Morris LL, Bedwell JR, Das P, Zhu H, Lee Y Allen J, Peltz A, Chin K, Schiff BA, Randall DM, Swords C, French D, Ward E, Sweeney JM, Warrillow SJ, Arora A, Narula A, McGrath BA, Cameron TS, Roberson DW. Global Tracheostomy Collaborative: data-driven improvements in patient safety through multidisciplinary teamwork, standardisation, education, and patient partnership. Br J Anaesth. 2020 Jul;125(1):e104-e118. doi: 10.1016/j.bja.2020.04.054. Epub 2020 May 23.
- A study website including information for clinicians, researchers and participants. Links will be available to study documents and to register interest in participating as a site.Link provided by the sponsor.
- 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.
Michelle Smyth, BSc contact
13 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheostomy Patients and Tracheostomy Decannulation, run by Royal College of Surgeons, Ireland at 13 sites in 8 countries.
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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Ireland, Italy, United States, Brazil, Canada and 3 more countries. 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 Aisling Mc Mahon, MB BCh BAO FCAI FJFICMI (+35318032204, aislingmcmahon@mater.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful tracheostomy decannulation (time frame: 90 days). 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 NCT07769021, which also lists 32 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 17 Aug 2026.