Actively Recruiting

Age: 18Years +
All Genders
ID06552676

Risk Factors for Neck Phlegmon After Percutaneous Tracheostomy in ICU

Led by Azienda Usl di Bologna · Updated on 2024-08-14

300

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

riSk Factors fOR neCk phlEgmon afteR pErcutaneous tRacheostomy in ICU

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 18 years
  • Presence of indication for tracheostomy
Not Eligible

You will not qualify if you...

  • Failure of the percutaneous tracheostomy technique or recourse to surgical tracheostomy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Implementation

Duration - Varies according to ICU stay

Participants undergo percutaneous tracheostomy during their ICU stay.

1 procedure visit

Surveillance

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

Trial Site Locations

Total: 1 location

1

Maggiore Hospital Carlo Alberto Pizzardi

Bologna, Italy, 40024

Actively Recruiting

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Research Team

L

Lorenzo Gamberini, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Development of an Italian version of the Leicester cough questionnaire and its relationship with other symptom-specific measures for patients with chronic cough.

Alessandra Sorano, Carlo Fumagalli, Elenia Cinelli...

https://pubmed.ncbi.nlm.nih.gov/38670318

The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies.

Erik von Elm, Douglas G Altman, Matthias Egger...

https://pubmed.ncbi.nlm.nih.gov/17941714