riSk Factors fOR neCk phlEgmon afteR pErcutaneous tRacheostomy in ICU (SORCERER)

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

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Tracheostomy Complication
• Intervention / Treatment: Procedure: Percutaneous tracheostomy

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Lorenzo Gamberini, MD; Phone Number: +393403550540; Email: gamberini6@ausl.bologna.it

Study Locations

• Italy
  • Bologna, Italy, 40024
    • Recruiting
    • Maggiore Hospital Carlo Alberto Pizzardi
    • Contact: Lorenzo Gamberini, MD; Phone Number: +393403550540; Email: gamberini6@ausl.bologna.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients admitted to Intensive Care undergoing percutaneous tracheostomy for any cause

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Percutaneous tracheostomy; Patients receiving percutaneous tracheostomy for any reason during their ICU stay	Procedure: Percutaneous tracheostomy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck phlegmon	Neck phlegmon in the incisional site	7 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Azienda Usl di Bologna

Publications and helpful links

General Publications

• von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. PLoS Med. 2007 Oct 16;4(10):e296. doi: 10.1371/journal.pmed.0040296.
• Silvester W, Goldsmith D, Uchino S, Bellomo R, Knight S, Seevanayagam S, Brazzale D, McMahon M, Buckmaster J, Hart GK, Opdam H, Pierce RJ, Gutteridge GA. Percutaneous versus surgical tracheostomy: A randomized controlled study with long-term follow-up. Crit Care Med. 2006 Aug;34(8):2145-52. doi: 10.1097/01.CCM.0000229882.09677.FD.
• Schindler A, Mozzanica F, Monzani A, Ceriani E, Atac M, Jukic-Peladic N, Venturini C, Orlandoni P. Reliability and validity of the Italian Eating Assessment Tool. Ann Otol Rhinol Laryngol. 2013 Nov;122(11):717-24. doi: 10.1177/000348941312201109.
• Forti S, Amico M, Zambarbieri A, Ciabatta A, Assi C, Pignataro L, Cantarella G. Validation of the Italian Voice Handicap Index-10. J Voice. 2014 Mar;28(2):263.e17-263.e22. doi: 10.1016/j.jvoice.2013.07.013. Epub 2013 Oct 2.
• Sorano A, Fumagalli C, Cinelli E, Birring SS, Fontana GA, Lavorini F. Development of an Italian version of the Leicester cough questionnaire and its relationship with other symptom-specific measures for patients with chronic cough. Respir Med. 2024 Jun;227:107642. doi: 10.1016/j.rmed.2024.107642. Epub 2024 Apr 24.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2018
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: August 10, 2024
• First Submitted That Met QC Criteria: August 10, 2024
• First Posted (Actual): August 14, 2024

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 10, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Connective Tissue Diseases; Skin Diseases, Infectious; Suppuration; Cellulitis
• Other Study ID Numbers: SORCERER - 24088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No