Tracheostomy WeaningNCT05271786
WEANING FROM TRACHEOSTOMY
An observational study of Tracheostomy Weaning and Tracheostomy Decannulation, run by University of Milan at 1 site in Italy.
Trial summary
Tracheostomy is a very common surgical procedure performed in critically ill patients on invasive mechanical ventilation, and usually performed in difficult-to-wean patients and whn prolonged mechanical ventilation is required. Weaning from the tracheostomy cannula (i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy Weaning, Tracheostomy Decannulation
- What is being tested?
- Decannulation
- How many people
- 192 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2022to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients who underwent a tracheostomy procedure and decannulation during their hospital stay since January 2017 until November 2021.
Who may be able to join
- Patients >18 years old
- Percutaneous tracheostomy
- At least one decannulation attempt
Who cannot join
- Surgical/permanent tracheostomy
- Elective tracheostomy due to neck masses or tumors, in view of a surgical approach
- Patients tracheostomized more than once
Trial locations and contacts
1 site in 1 country.
About this study
Official title: WEANING FROM TRACHEOSTOMY: A MULTICENTER, OBSERVATIONAL REVIEW OF PROCEDURES AND PROTOCOLS AND A RESTROSPECTIVE VALIDATION OF THE QSQ SCORING SYSTEM
Tracheostomy is a very common surgical procedure performed in critically ill patients on invasive mechanical ventilation, and usually performed in difficult-to-wean patients and whn prolonged mechanical ventilation is required.
Weaning from the tracheostomy cannula (i.e. decannulation) represents one of the crucial steps in the post-acute respiratory management of these patients. Tracheostomy literature mainly focuses on the timing and technique of this procedure, but there is a lack of studies about decannulation and, currently, our knowledge is primarily based on expert opinion. The COVID-19 pandemic, due to the rapid increase in the number of patients exposed to prolonged mechanical ventilation, has stressed the need for objective parameters and shared standardized protocols to perform weaning from tracheostomy.
Read the detailed description
The study will have two co-primary objectives:
- To review and compare the standard operating procedures adopted for decannulation at a multicenter level.
- To retrospectively validate a clinical score for weaning from trachesotomy (Quantitative-Semi Quantitative - QSQ) Secondary objectives will be: 1) to assess the presence of predictors of decannulation failure; 2) to investigate if timing of decannulation can influence the result of the tracheostomy weaning process, and 3) to possibly derive a novel clinical score and a shared protocol for decannulation.
The investigators will retrospectively collect data from patients who underwent a tracheostomy procedure and decannulation during their hospital stay since January 2017 until November 2021.
A digital dataset will be shared with the participating centers. The following variables will be collected: age, gender, comorbidities, reason and date of tracheostomy, technique used, type of cannula, variables associated with the weaning process (timing and type of caliber reduction, tube capping, assessment of airway patency by means of fiberoptic bronchoscopy, effectiveness of cough and swallowing, type and timing of change in respiratory support), level of consciousness, vital signs, arterial blood gas analysis and blood tests before and after decannulation, failure of decannulation and related complications. The dataset will be also designed to retrospectively validate the QsQ score, which is based on two main criteria (or quantitative parameters) and eight minor criteria (or semi-quantitative parameters).
Inclusion criteria
- Patients >18 years old
- Percutaneous tracheostomy performed for any reason
- At least one decannulation attempt during the hospitalization period. Exclusion criteria
- Patients with surgical/permanent tracheostomy (e.g. neuromuscular disorders needing long-term invasive mechanical ventilation) 2. Patients that underwent elective tracheostomy due to neck masses or tumors, in view of a surgical approach 3. Patients tracheostomized more than once
- Conditions
- Tracheostomy Weaning, Tracheostomy Decannulation
- Being tested
- Decannulation
- Keywords
- tracheostomy weaning, tracheostomy decannulation, Quantitative-Semi Quantitative - QSQ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecannulationOther
retrospective evaluation of decannulation
| Study group | Role | What they receive |
|---|---|---|
| Tracheostomized patients | Patients who underwent percutaneous tracheostomy performed for any reason Receives: Other: Decannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard procedures of decannulation
To review and compare the standard operating procedures adopted for decannulation at a multicenter level.
Measured: 5 years
QSQ score
To retrospectively validate a clinical score for weaning from trachesotomy (Quantitative-Semi Quantitative - QSQ )
Measured: 5 years
Secondary outcomes (3)
Predictors of decannulation failure
Assessment of the presence of predictors of decannulation failure
Measured: 5 years
Time of decannulation and its influence on the weaning process
Investigation if timing of decannulation can influence the result of the tracheostomy weaning process
Measured: 5 years
Shared protocol and clinical score
Possible derivation of a novel clinical score and a shared protocol for decannulation
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start1 Apr 2022
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tracheostomy WeaningStudies 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
- Retrospective
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Collaborators
- Dejan Radovanovic, Marina Gatti, Michele Mondoni, Stefano Centanni, Frascesco Blasi, Andrea Gramegna, Fabiano Di Marco, Stefano Aliberti, Humanitas Research Hospital IRCCS, Rozzano-Milan, Ca' Granda Policlinico Milano, ASST Santi Paolo e Carlo, Ospedale Luigi Sacco Milano, A.O. Ospedale Papa Giovanni XXIII
- Responsible party
- Principal investigator, Pierachille Santus, MD, PhD, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271786
- Sponsor's protocol ID
- OR022022
- Status last verified
- Sep 2025
- First submitted
- 28 Feb 2022
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Radovanovic D, Di Marco F, Mondoni M, Crimi C, Gramegna A, Gatti M, Signorello JC, Raimondi F, Albrici C, Morana G, Blasi FBA, Santus P. Determinants of time to decannulation and predictors of early weaning from tracheostomy: a multicenter, retrospective Italian cohort study. Ann Intensive Care. 2026 Mar 17;16:100050. doi: 10.1016/j.aicoj.2026.100050. eCollection 2026.
PubMed 41884465
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WEANING FROM TRACHEOSTOMY: A MULTICENTER, OBSERVATIONAL REVIEW OF PROCEDURES AND PROTOCOLS AND A RESTROSPECTIVE VALIDATION OF THE QSQ SCORING SYSTEM
- ClinicalTrials.gov ID
- NCT05271786
- Acronym / sponsor ID
- OR022022
- Conditions
- Tracheostomy Weaning, Tracheostomy Decannulation
- Keywords
- tracheostomy weaning, tracheostomy decannulation, Quantitative-Semi Quantitative - QSQ
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Collaborators
- Dejan Radovanovic, Marina Gatti, Michele Mondoni, Stefano Centanni, Frascesco Blasi, Andrea Gramegna, Fabiano Di Marco, Stefano Aliberti, Humanitas Research Hospital IRCCS, Rozzano-Milan, Ca' Granda Policlinico Milano, ASST Santi Paolo e Carlo, Ospedale Luigi Sacco Milano, A.O. Ospedale Papa Giovanni XXIII
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 9 Mar 2022 (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.
Tracheostomy is a very common surgical procedure performed in critically ill patients on invasive mechanical ventilation, and usually performed in difficult-to-wean patients and whn prolonged mechanical ventilation is required.
Weaning from the tracheostomy cannula (i.e. decannulation) represents one of the crucial steps in the post-acute respiratory management of these patients. Tracheostomy literature mainly focuses on the timing and technique of this procedure, but there is a lack of studies about decannulation and, currently, our knowledge is primarily based on expert opinion. The COVID-19 pandemic, due to the rapid increase in the number of patients exposed to prolonged mechanical ventilation, has stressed the need for objective parameters and shared standardized protocols to perform weaning from tracheostomy.
Detailed description
The study will have two co-primary objectives:
- To review and compare the standard operating procedures adopted for decannulation at a multicenter level.
- To retrospectively validate a clinical score for weaning from trachesotomy (Quantitative-Semi Quantitative - QSQ) Secondary objectives will be: 1) to assess the presence of predictors of decannulation failure; 2) to investigate if timing of decannulation can influence the result of the tracheostomy weaning process, and 3) to possibly derive a novel clinical score and a shared protocol for decannulation.
The investigators will retrospectively collect data from patients who underwent a tracheostomy procedure and decannulation during their hospital stay since January 2017 until November 2021.
A digital dataset will be shared with the participating centers. The following variables will be collected: age, gender, comorbidities, reason and date of tracheostomy, technique used, type of cannula, variables associated with the weaning process (timing and type of caliber reduction, tube capping, assessment of airway patency by means of fiberoptic bronchoscopy, effectiveness of cough and swallowing, type and timing of change in respiratory support), level of consciousness, vital signs, arterial blood gas analysis and blood tests before and after decannulation, failure of decannulation and related complications. The dataset will be also designed to retrospectively validate the QsQ score, which is based on two main criteria (or quantitative parameters) and eight minor criteria (or semi-quantitative parameters).
Inclusion criteria
- Patients >18 years old
- Percutaneous tracheostomy performed for any reason
- At least one decannulation attempt during the hospitalization period. Exclusion criteria
- Patients with surgical/permanent tracheostomy (e.g. neuromuscular disorders needing long-term invasive mechanical ventilation) 2. Patients that underwent elective tracheostomy due to neck masses or tumors, in view of a surgical approach 3. Patients tracheostomized more than once
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tracheostomized patients | – | Other: DecannulationPatients who underwent percutaneous tracheostomy performed for any reason |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent a tracheostomy procedure and decannulation during their hospital stay since January 2017 until November 2021.
Key inclusion criteria (3 listed)
- Patients >18 years old
- Percutaneous tracheostomy
- At least one decannulation attempt
Key exclusion criteria (3 listed)
- Surgical/permanent tracheostomy
- Elective tracheostomy due to neck masses or tumors, in view of a surgical approach
- Patients tracheostomized more than once
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decannulationretrospective evaluation of decannulation | Other | Tracheostomized patients |
Primary outcome
Standard procedures of decannulation
Time frame: 5 years
To review and compare the standard operating procedures adopted for decannulation at a multicenter level.
QSQ score
Time frame: 5 years
To retrospectively validate a clinical score for weaning from trachesotomy (Quantitative-Semi Quantitative - QSQ )
3 secondary outcomes
Predictors of decannulation failure
Time frame: 5 years
Time of decannulation and its influence on the weaning process
Time frame: 5 years
Shared protocol and clinical score
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Derived from this study: PubMed 41884465Radovanovic D, Di Marco F, Mondoni M, Crimi C, Gramegna A, Gatti M, Signorello JC, Raimondi F, Albrici C, Morana G, Blasi FBA, Santus P. Determinants of time to decannulation and predictors of early weaning from tracheostomy: a multicenter, retrospective Italian cohort study. Ann Intensive Care. 2026 Mar 17;16:100050. doi: 10.1016/j.aicoj.2026.100050. eCollection 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Tracheostomy Weaning and Tracheostomy Decannulation, run by University of Milan at 1 site in Italy.
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 3 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: finished, as of the sponsor's last update on 10 Sep 2025. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard procedures of decannulation (time frame: 5 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 NCT05271786, which also lists 1 linked publication.
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 10 Sep 2025.