riSk Factors fOR neCk phlEgmon afteR pErcutaneous tRacheostomy in ICU
NCT ID: NCT06552676
Last Updated: 2024-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2018-08-09
2025-01-31
Brief Summary
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Participant Population/Primary Condition: Patients admitted to Intensive Care
Main Questions Aims to Answer:
1. \- What are the risk factors associated with the development of tracheal phlegmon percutaneous tracheostomy?
2. \- 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
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Percutaneous tracheostomy
Patients receiving percutaneous tracheostomy for any reason during their ICU stay
Percutaneous tracheostomy
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.
Interventions
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Percutaneous tracheostomy
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.
Eligibility Criteria
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Inclusion Criteria
* Presence of indication for tracheostomy
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Azienda Usl di Bologna
OTHER_GOV
Responsible Party
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Locations
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Maggiore Hospital Carlo Alberto Pizzardi
Bologna, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Schindler 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.
Forti 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.
Sorano 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.
von 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.
Mehta 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.
Voelker 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.
Other Identifiers
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SORCERER - 24088
Identifier Type: -
Identifier Source: org_study_id
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