riSk Factors fOR neCk phlEgmon afteR pErcutaneous tRacheostomy in ICU

Recruiting

• Conditions: Tracheostomy Complication; Quality of Life
• Interventions: Procedure: Percutaneous tracheostomy

• Registration Number: NCT06552676
• Lead Sponsor: Azienda Usl di Bologna

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-09
• Status Verified: 2024-08
• Study First Submitted: 2024-08-10
• Study First Submitted QC: 2024-08-10
• Last Update Submitted: 2024-08-10
• Study First Posted: 2024-08-14
• Last Update Posted: 2024-08-14
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Percutaneous tracheostomy	Percutaneous tracheostomy	Patients receiving percutaneous tracheostomy for any reason during their ICU stay

Primary Outcome Measures

Name	Time	Method
Neck phlegmon	7 days	Neck phlegmon in the incisional site

Secondary Outcome Measures

Name	Time	Method
Intensive Care Stay	1 year	Days of ICU stay
Hospital Stay	1 year	Days of hospital stay
Mortality	30 days	30 days mortality
Cough	2 years	Leicester Cough Questionnaire - LCQ
Dysphonia	2 years	Voice Handicap Index - VHI-10 questionnaire
Dyspnoea	2 years	Modified Medical Research Council Dyspnea Scale - mMRC-10
Health related quality of life	2 years	15D instrument
Dysphagia	2 years	Eating Attitude test - EAT-10 questionnaire

Trial Locations

Locations (1)

Maggiore Hospital Carlo Alberto Pizzardi; 🇮🇹 Bologna, Italy