Health TrialsbyHealthPanel

riSk Factors fOR neCk phlEgmon afteR pErcutaneous tRacheostomy in ICU

ConditionsTracheostomy ComplicationQuality of Life
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Usl di Bologna

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age greater than 18 years

Presence of indication for tracheostomy

Disqualifiers

Failure of the percutaneous tracheostomy technique or recourse to surgical tracheostomy

Trial population

Patients admitted to Intensive Care undergoing percutaneous tracheostomy for any cause

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Percutaneous tracheostomy

    Procedure/Surgery

    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.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Percutaneous tracheostomy1 intervention

Trial outcomes

Primary outcomes

1

Neck phlegmon

Neck phlegmon in the incisional site

Time frame
7 days

Secondary outcomes

1

Intensive Care Stay

Days of ICU stay

Time frame
1 year
2

Hospital Stay

Days of hospital stay

Time frame
1 year
3

Mortality

30 days mortality

Time frame
30 days
4

Health related quality of life

15D instrument

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Azienda Usl di Bologna

Lead sponsor

Source ClinicalTrials.gov
Apply now