Menu
Recruiting NCT06552676

riSk Factors fOR neCk phlEgmon afteR pErcutaneous tRacheostomy in ICU

— Observational Tracheostomy Complication Quality of Life

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Percutaneous tracheostomy.
Who it may be relevant to
Registry conditions: Tracheostomy Complication, Quality of Life. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Risk Factors for Neck Phlegmon After Percutaneous Tracheostomy in ICU

Overview

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

Interventions

  • 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.

Primary outcome measures

  • Neck phlegmon [Time frame: 7 days]
Secondary outcome measures (8)
  • Intensive Care Stay [Time frame: 1 year]
  • Hospital Stay [Time frame: 1 year]
  • Mortality [Time frame: 30 days]
  • Health related quality of life [Time frame: 2 years]
  • Dysphagia [Time frame: 2 years]
  • Dysphonia [Time frame: 2 years]
  • Dyspnoea [Time frame: 2 years]
  • Cough [Time frame: 2 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Maggiore Hospital Carlo Alberto Pizzardi — Bologna

Publications

  • 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. PMID 16775568
  • 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. PMID 24358633
  • 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. PMID 24094800
  • 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. PMID 38670318
  • 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. PMID 17941714
  • 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. PMID 28775631
  • 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. PMID 28465381

Identifiers

NCT: NCT06552676 · SORCERER - 24088

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗