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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percutaneous tracheostomy | Patients receiving percutaneous tracheostomy for any reason during their ICU stay |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous tracheostomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Neck phlegmon | Neck phlegmon in the incisional site | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Intensive Care Stay | Days of ICU stay | 1 year |
| Hospital Stay | Days of hospital stay | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients admitted to Intensive Care undergoing percutaneous tracheostomy for any cause
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lorenzo Gamberini, MD | Contact | +393403550540 | gamberini6@ausl.bologna.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maggiore Hospital Carlo Alberto Pizzardi | Recruiting | Bologna | 40024 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16775568 | Background | 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. | |
| 24358633 |
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| Mortality | 30 days mortality | 30 days |
| Health related quality of life | 15D instrument | 2 years |
| Dysphagia | Eating Attitude test - EAT-10 questionnaire | 2 years |
| Dysphonia | Voice Handicap Index - VHI-10 questionnaire | 2 years |
| Dyspnoea | Modified Medical Research Council Dyspnea Scale - mMRC-10 | 2 years |
| Cough | Leicester Cough Questionnaire - LCQ | 2 years |
| 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. |
| 24094800 | Background | 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. |
| 38670318 | Background | 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. |
| 17941714 | Background | 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. |
| 28775631 | Result | 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. |
| 28465381 | Result | 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. |