Clinical trial NCT06552676: riSk Factors fOR neCk phlEgmon afteR pErcutaneous tRacheostomy in ICU
Official title: Risk Factors for Neck Phlegmon After Percutaneous Tracheostomy in ICU
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tracheostomy Complication
Quality of Life
Lead sponsor: Azienda Usl di Bologna
Sponsor class: OTHER_GOV
First posted: 2024-08-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to Intensive Care undergoing percutaneous tracheostomy for any cause

Brief 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. - 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


Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years
* Presence of indication for tracheostomy

Exclusion Criteria:

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

Primary outcomes:
measure: Neck phlegmon
timeFrame: 7 days
Secondary outcomes:
measure: Intensive Care Stay
timeFrame: 1 year
measure: Hospital Stay
timeFrame: 1 year
measure: Mortality
timeFrame: 30 days
measure: Health related quality of life
timeFrame: 2 years
measure: Dysphagia
timeFrame: 2 years
measure: Dysphonia
timeFrame: 2 years
measure: Dyspnoea
timeFrame: 2 years
measure: Cough
timeFrame: 2 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Maggiore Hospital Carlo Alberto Pizzardi
Study officials:
References:
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citation: 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.
citation: 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.