NCT06552676

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. 1.\- What are the risk factors associated with the development of tracheal phlegmon percutaneous tracheostomy?
  2. 2.\- How does the appearance of tracheal phlegmon impact intensive care stay, hospital stay, mortality, and Health-related quality of life?

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 9, 2018

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

August 14, 2024

Status Verified

August 1, 2024

Enrollment Period

6.4 years

First QC Date

August 10, 2024

Last Update Submit

August 10, 2024

Conditions

Tracheostomy ComplicationQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Neck phlegmon

    Neck phlegmon in the incisional site

    7 days

Secondary Outcomes (8)

  • Intensive Care Stay

    1 year

  • Hospital Stay

    1 year

  • Mortality

    30 days

  • Health related quality of life

    2 years

  • Dysphagia

    2 years

  • +3 more secondary outcomes

Study Arms (1)

Percutaneous tracheostomy

Patients receiving percutaneous tracheostomy for any reason during their ICU stay

Procedure: Percutaneous tracheostomy

Interventions

Percutaneous tracheostomyPROCEDURE

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.

Percutaneous tracheostomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted to Intensive Care undergoing percutaneous tracheostomy for any cause

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maggiore Hospital Carlo Alberto Pizzardi

Bologna, 40024, Italy

RECRUITING

Related Publications (7)

  • 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: 16775568BACKGROUND

  • 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: 24358633BACKGROUND

  • 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: 24094800BACKGROUND

  • 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: 38670318BACKGROUND

  • 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: 17941714BACKGROUND

  • 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: 28775631RESULT

  • 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: 28465381RESULT

Central Study Contacts

Lorenzo Gamberini, MD

CONTACT

+393403550540gamberini6@ausl.bologna.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2024

First Posted

August 14, 2024

Study Start

August 9, 2018

Primary Completion

December 31, 2024

Study Completion

January 31, 2025

Last Updated

August 14, 2024

Record last verified: 2024-08

Locations

IT(1)