Tracheostomy ComplicationSORCERERNCT06552676
riSk Factors fOR neCk phlEgmon afteR pErcutaneous tRacheostomy in ICU
An observational study of Tracheostomy Complication and Quality of Life, run by Azienda Usl di Bologna at 1 site in Italy.
Trial summary
Primary Purpose: To investigate the incidence and risk factors related to the appearance of tracheal phlegmon in patients undergoing percutaneous tracheostomy. Participant Population/Primary Condition: Patients admitted to Intensive Care Main Questions Aims to Answer: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy Complication, Quality of Life
- What is being tested?
- Percutaneous tracheostomy
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 9 Aug 2018to 31 Jan 2025
- 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 admitted to Intensive Care undergoing percutaneous tracheostomy for any cause
Who may be able to join
- Age greater than 18 years
- Presence of indication for tracheostomy
Who cannot join
- Failure of the percutaneous tracheostomy technique or recourse to surgical tracheostomy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Maggiore Hospital Carlo Alberto Pizzardi
Bologna, 40024
Lorenzo Gamberini, MD, +393403550540, gamberini6@ausl.bologna.it
About this study
Official title: Risk Factors for Neck Phlegmon After Percutaneous Tracheostomy in ICU
Primary Purpose: To investigate the incidence and risk factors related to the appearance of tracheal phlegmon in patients undergoing percutaneous tracheostomy.
Participant Population/Primary Condition: Patients admitted to Intensive Care
Main Questions Aims to Answer:
- - What are the risk factors associated with the development of tracheal phlegmon percutaneous tracheostomy?
- - How does the appearance of tracheal phlegmon impact intensive care stay, hospital stay, mortality, and Health-related quality of life?
Participants will be followed up after undergoing tracheostomy for 7 days to identify eventual phlegmons.
At the two-year follow-up, the health-related quality of life will be assessed
- Conditions
- Tracheostomy Complication, Quality of Life
- Being tested
- Percutaneous tracheostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous tracheostomyProcedure or surgery
Percutaneous tracheostomy is a widely used technique in intensive care. It involves creating a passage between the tracheal lumen and the outside, through which a cannula is placed.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous tracheostomy | Patients receiving percutaneous tracheostomy for any reason during their ICU stay Receives: Procedure: Percutaneous tracheostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck phlegmon
Neck phlegmon in the incisional site
Measured: 7 days
Secondary outcomes (8)
Intensive Care Stay
Days of ICU stay
Measured: 1 year
Hospital Stay
Days of hospital stay
Measured: 1 year
Mortality
30 days mortality
Measured: 30 days
Health related quality of life
15D instrument
Measured: 2 years
Dysphagia
Eating Attitude test - EAT-10 questionnaire
Measured: 2 years
Dysphonia
Voice Handicap Index - VHI-10 questionnaire
Measured: 2 years
Dyspnoea
Modified Medical Research Council Dyspnea Scale - mMRC-10
Measured: 2 years
Cough
Leicester Cough Questionnaire - LCQ
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 posted14 Aug 2024
- Study start9 Aug 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jan 2025 (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 Tracheostomy ComplicationStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Usl di Bologna
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552676
- Sponsor's protocol ID
- SORCERER - 24088
- Acronym
- SORCERER
- Status last verified
- Aug 2024
- First submitted
- 10 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Silvester W, Goldsmith D, Uchino S, Bellomo R, Knight S, Seevanayagam S, Brazzale D, McMahon M, Buckmaster J, Hart GK, Opdam H, Pierce RJ, Gutteridge GA. Percutaneous versus surgical tracheostomy: A randomized controlled study with long-term follow-up. Crit Care Med. 2006 Aug;34(8):2145-52. doi: 10.1097/01.CCM.0000229882.09677.FD.
PubMed 16775568Schindler A, Mozzanica F, Monzani A, Ceriani E, Atac M, Jukic-Peladic N, Venturini C, Orlandoni P. Reliability and validity of the Italian Eating Assessment Tool. Ann Otol Rhinol Laryngol. 2013 Nov;122(11):717-24. doi: 10.1177/000348941312201109.
PubMed 24358633Forti S, Amico M, Zambarbieri A, Ciabatta A, Assi C, Pignataro L, Cantarella G. Validation of the Italian Voice Handicap Index-10. J Voice. 2014 Mar;28(2):263.e17-263.e22. doi: 10.1016/j.jvoice.2013.07.013. Epub 2013 Oct 2.
PubMed 24094800Sorano A, Fumagalli C, Cinelli E, Birring SS, Fontana GA, Lavorini F. Development of an Italian version of the Leicester cough questionnaire and its relationship with other symptom-specific measures for patients with chronic cough. Respir Med. 2024 Jun;227:107642. doi: 10.1016/j.rmed.2024.107642. Epub 2024 Apr 24.
PubMed 38670318von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. PLoS Med. 2007 Oct 16;4(10):e296. doi: 10.1371/journal.pmed.0040296.
PubMed 17941714Mehta AK, Chamyal PC. TRACHEOSTOMY COMPLICATIONS AND THEIR MANAGEMENT. Med J Armed Forces India. 1999 Jul;55(3):197-200. doi: 10.1016/S0377-1237(17)30440-9. Epub 2017 Jun 26.
PubMed 28775631Voelker MT, Wiechmann M, Dietz A, Laudi S, Bercker S. Two-Year Follow-Up After Percutaneous Dilatational Tracheostomy in a Surgical ICU. Respir Care. 2017 Jul;62(7):963-969. doi: 10.4187/respcare.05290. Epub 2017 May 2.
PubMed 28465381
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Neck Phlegmon After Percutaneous Tracheostomy in ICU
- ClinicalTrials.gov ID
- NCT06552676
- Acronym / sponsor ID
- SORCERER / SORCERER - 24088
- Conditions
- Tracheostomy Complication, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Azienda Usl di BolognaOther government
- Study start
- 9 Aug 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 14 Aug 2024 (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.
Primary Purpose: To investigate the incidence and risk factors related to the appearance of tracheal phlegmon in patients undergoing percutaneous tracheostomy.
Participant Population/Primary Condition: Patients admitted to Intensive Care
Main Questions Aims to Answer:
- - What are the risk factors associated with the development of tracheal phlegmon percutaneous tracheostomy?
- - How does the appearance of tracheal phlegmon impact intensive care stay, hospital stay, mortality, and Health-related quality of life?
Participants will be followed up after undergoing tracheostomy for 7 days to identify eventual phlegmons.
At the two-year follow-up, the health-related quality of life will be assessed
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Percutaneous tracheostomy | – | Procedure: Percutaneous tracheostomyPatients receiving percutaneous tracheostomy for any reason during their ICU stay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to Intensive Care undergoing percutaneous tracheostomy for any cause
Key inclusion criteria (2 listed)
- Age greater than 18 years
- Presence of indication for tracheostomy
Key exclusion criteria (1 listed)
- Failure of the percutaneous tracheostomy technique or recourse to surgical tracheostomy
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 |
|---|---|---|
| Percutaneous tracheostomyPercutaneous tracheostomy is a widely used technique in intensive care. It involves creating a passage between the tracheal lumen and the outside, through which a cannula is placed. | Procedure or surgery | Percutaneous tracheostomy |
Primary outcome
Neck phlegmon
Time frame: 7 days
Neck phlegmon in the incisional site
8 secondary outcomes
Intensive Care Stay
Time frame: 1 year
Hospital Stay
Time frame: 1 year
Mortality
Time frame: 30 days
Health related quality of life
Time frame: 2 years
Dysphagia
Time frame: 2 years
Dysphonia
Time frame: 2 years
Dyspnoea
Time frame: 2 years
Cough
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Background: PubMed 16775568Silvester W, Goldsmith D, Uchino S, Bellomo R, Knight S, Seevanayagam S, Brazzale D, McMahon M, Buckmaster J, Hart GK, Opdam H, Pierce RJ, Gutteridge GA. Percutaneous versus surgical tracheostomy: A randomized controlled study with long-term follow-up. Crit Care Med. 2006 Aug;34(8):2145-52. doi: 10.1097/01.CCM.0000229882.09677.FD.
- Background: PubMed 24358633Schindler A, Mozzanica F, Monzani A, Ceriani E, Atac M, Jukic-Peladic N, Venturini C, Orlandoni P. Reliability and validity of the Italian Eating Assessment Tool. Ann Otol Rhinol Laryngol. 2013 Nov;122(11):717-24. doi: 10.1177/000348941312201109.
- Background: PubMed 24094800Forti S, Amico M, Zambarbieri A, Ciabatta A, Assi C, Pignataro L, Cantarella G. Validation of the Italian Voice Handicap Index-10. J Voice. 2014 Mar;28(2):263.e17-263.e22. doi: 10.1016/j.jvoice.2013.07.013. Epub 2013 Oct 2.
- Background: PubMed 38670318Sorano A, Fumagalli C, Cinelli E, Birring SS, Fontana GA, Lavorini F. Development of an Italian version of the Leicester cough questionnaire and its relationship with other symptom-specific measures for patients with chronic cough. Respir Med. 2024 Jun;227:107642. doi: 10.1016/j.rmed.2024.107642. Epub 2024 Apr 24.
- Background: PubMed 17941714von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. PLoS Med. 2007 Oct 16;4(10):e296. doi: 10.1371/journal.pmed.0040296.
- Results publication: PubMed 28775631Mehta AK, Chamyal PC. TRACHEOSTOMY COMPLICATIONS AND THEIR MANAGEMENT. Med J Armed Forces India. 1999 Jul;55(3):197-200. doi: 10.1016/S0377-1237(17)30440-9. Epub 2017 Jun 26.
- Results publication: PubMed 28465381Voelker MT, Wiechmann M, Dietz A, Laudi S, Bercker S. Two-Year Follow-Up After Percutaneous Dilatational Tracheostomy in a Surgical ICU. Respir Care. 2017 Jul;62(7):963-969. doi: 10.4187/respcare.05290. Epub 2017 May 2.
- 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. This study is not recruiting at the moment.
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 Complication and Quality of Life, run by Azienda Usl di Bologna 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 2 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: status not confirmed, as of the sponsor's last update on 14 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lorenzo Gamberini, MD (+393403550540, gamberini6@ausl.bologna.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck phlegmon (time frame: 7 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 NCT06552676, 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 14 Aug 2024.