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NCT Number: NCT06552676

riSk Factors fOR neCk phlEgmon afteR pErcutaneous tRacheostomy in ICU

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

Recruiting

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Key information

Conditions

Tracheostomy Complication Quality of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maggiore Hospital Carlo Alberto Pizzardi

Bologna, 40024, Italy

Location status: Recruiting

Location contact

Lorenzo Gamberini, MD

CONTACT

[email protected]

+393403550540

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous tracheostomy

Procedure

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.

Primary outcomes

  1. Neck phlegmon

    Time frame: 7 days

    Neck phlegmon in the incisional site

Secondary outcomes

  1. Intensive Care Stay

    Time frame: 1 year

    Days of ICU stay

  2. Hospital Stay

    Time frame: 1 year

    Days of hospital stay

  3. Mortality

    Time frame: 30 days

    30 days mortality

  4. Health related quality of life

    Time frame: 2 years

    15D instrument

  5. Dysphagia

    Time frame: 2 years

    Eating Attitude test - EAT-10 questionnaire

  6. Dysphonia

    Time frame: 2 years

    Voice Handicap Index - VHI-10 questionnaire

  7. Dyspnoea

    Time frame: 2 years

    Modified Medical Research Council Dyspnea Scale - mMRC-10

  8. Cough

    Time frame: 2 years

    Leicester Cough Questionnaire - LCQ

Study contacts

Contact information is provided by the study sponsor or research team.

Lorenzo Gamberini, MD

CONTACT

[email protected]

+393403550540

Sponsors and collaborators

Lead sponsor

Azienda Usl di Bologna

Other Gov

Registry information

Acronym: SORCERER

Important dates

Study start
2018
Primary completion
2024
Study completion
2025
First posted
Aug 14, 2024
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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