Percutaneous versus surgical tracheostomy: A randomized controlled study with long-term follow-up.
William Silvester, Donna Goldsmith, Shige Uchino...
https://pubmed.ncbi.nlm.nih.gov/16775568Actively Recruiting
Led by Azienda Usl di Bologna · Updated on 2024-08-14
300
Participants Needed
1
Research Sites
4 weeks
Total Duration
Researchers are studying patients admitted to intensive care who undergo percutaneous tracheostomy to understand the risk factors leading to the development of neck phlegmon, a possible complication after this procedure. The study aims to see how this complication affects hospital stay length, mortality, and quality of life over time. This observational study is sponsored by Azienda Usl di Bologna and focuses on health outcomes related to tracheostomy complications. Participants receive a percutaneous tracheostomy, a procedure that creates a direct airway passage in the neck by placing a cannula through the trachea. The study observes patients receiving this procedure for any reason during their ICU stay. There is no treatment assigned by the study; instead, researchers monitor outcomes following the procedure. Participants are followed for 7 days after the tracheostomy to detect any neck phlegmon formation. Additional follow-ups occur up to two years to assess health-related quality of life and symptoms such as swallowing difficulties, voice problems, breathing issues, and cough. Researchers also track intensive care and hospital stays, as well as mortality within 30 days. The total participation duration includes immediate post-procedure monitoring and long-term health assessments.
CONDITIONS
riSk Factors fOR neCk phlEgmon afteR pErcutaneous tRacheostomy in ICU
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Varies according to ICU stay
Participants undergo percutaneous tracheostomy during their ICU stay.
1 procedure visit
Duration - Up to 2 years
Participants are monitored for neck phlegmon and other health outcomes following the procedure.
Follow-up visits up to 2 years depending on health status
Total: 1 location
1
Maggiore Hospital Carlo Alberto Pizzardi
Bologna, Italy, 40024
Actively Recruiting
L
Lorenzo Gamberini, MD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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