WEANING FROM TRACHEOSTOMY

NCT05271786 | Completed

• 1 other identifier: OR022022
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

Tracheostomy is a very common surgical procedure performed in critically ill patients on invasive mechanical ventilation, and usually performed in difficult-to-wean patients and whn prolonged mechanical ventilation is required. Weaning from the tracheostomy cannula (i.e. decannulation) represents one of the crucial steps in the post-acute respiratory management of these patients. Tracheostomy literature mainly focuses on the timing and technique of this procedure, but there is a lack of studies about decannulation and, currently, our knowledge is primarily based on expert opinion. The COVID-19 pandemic, due to the rapid increase in the number of patients exposed to prolonged mechanical ventilation, has stressed the need for objective parameters and shared standardized protocols to perform weaning from tracheostomy.

Conditions

Tracheostomy Weaning; Tracheostomy Decannulation

Keywords

tracheostomy weaning; tracheostomy decannulation; Quantitative-Semi Quantitative - QSQ

Outcome Measures

Primary Outcomes (2)

• Standard procedures of decannulation

  To review and compare the standard operating procedures adopted for decannulation at a multicenter level.

  5 years

• QSQ score

  To retrospectively validate a clinical score for weaning from trachesotomy (Quantitative-Semi Quantitative - QSQ )

  5 years

Secondary Outcomes (3)

• Predictors of decannulation failure

  5 years

• Time of decannulation and its influence on the weaning process

  5 years

• Shared protocol and clinical score

  5 years

Study Arms (1)

Tracheostomized patients

Patients who underwent percutaneous tracheostomy performed for any reason

Other: Decannulation

Interventions

Decannulation OTHER

retrospective evaluation of decannulation

Tracheostomized patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who underwent a tracheostomy procedure and decannulation during their hospital stay since January 2017 until November 2021.

You may qualify if:

• Patients \>18 years old
• Percutaneous tracheostomy
• At least one decannulation attempt

You may not qualify if:

• Surgical/permanent tracheostomy
• Elective tracheostomy due to neck masses or tumors, in view of a surgical approach
• Patients tracheostomized more than once

Sponsors & Collaborators

• University of Milan: lead
• Dejan Radovanovic: collaborator
• Marina Gatti: collaborator
• Michele Mondoni: collaborator
• Stefano Centanni: collaborator
• Frascesco Blasi: collaborator
• Andrea Gramegna: collaborator
• Fabiano Di Marco: collaborator
• Stefano Aliberti: collaborator
• Humanitas Research Hospital IRCCS, Rozzano-Milan: collaborator
• Ca' Granda Policlinico Milano: collaborator
• ASST Santi Paolo e Carlo: collaborator
• Ospedale Luigi Sacco Milano: collaborator
• Papa Giovanni XXIII Bergamo: collaborator

Study Sites (1)

L. Sacco Hospital

Milan, 20157, Italy

Location

MeSH Terms

Interventions

Tracheostomy Decannulation

Intervention Hierarchy (Ancestors)

Tracheostomy; Airway Management; Therapeutics; Device Removal; Surgical Procedures, Operative; Ostomy; Otorhinolaryngologic Surgical Procedures; Thoracic Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 9, 2022
• Study Start: April 1, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)