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Completed

NCT Number: NCT05271786

WEANING FROM TRACHEOSTOMY

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.

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Key information

Conditions

Tracheostomy Weaning Tracheostomy Decannulation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

L. Sacco Hospital

Milan, 20157, Italy

About this study

The study will have two co-primary objectives:

  • To review and compare the standard operating procedures adopted for decannulation at a multicenter level.
  • To retrospectively validate a clinical score for weaning from trachesotomy (Quantitative-Semi Quantitative - QSQ) Secondary objectives will be: 1) to assess the presence of predictors of decannulation failure; 2) to investigate if timing of decannulation can influence the result of the tracheostomy weaning process, and 3) to possibly derive a novel clinical score and a shared protocol for decannulation.

The investigators will retrospectively collect data from patients who underwent a tracheostomy procedure and decannulation during their hospital stay since January 2017 until November 2021.

A digital dataset will be shared with the participating centers. The following variables will be collected: age, gender, comorbidities, reason and date of tracheostomy, technique used, type of cannula, variables associated with the weaning process (timing and type of caliber reduction, tube capping, assessment of airway patency by means of fiberoptic bronchoscopy, effectiveness of cough and swallowing, type and timing of change in respiratory support), level of consciousness, vital signs, arterial blood gas analysis and blood tests before and after decannulation, failure of decannulation and related complications. The dataset will be also designed to retrospectively validate the QsQ score, which is based on two main criteria (or quantitative parameters) and eight minor criteria (or semi-quantitative parameters).

Inclusion criteria

  • Patients >18 years old
  • Percutaneous tracheostomy performed for any reason
  • At least one decannulation attempt during the hospitalization period. Exclusion criteria
  • Patients with surgical/permanent tracheostomy (e.g. neuromuscular disorders needing long-term invasive mechanical ventilation) 2. Patients that underwent elective tracheostomy due to neck masses or tumors, in view of a surgical approach 3. Patients tracheostomized more than once

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Decannulation

Other

retrospective evaluation of decannulation

Primary outcomes

  1. Standard procedures of decannulation

    Time frame: 5 years

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

  2. QSQ score

    Time frame: 5 years

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

Secondary outcomes

  1. Predictors of decannulation failure

    Time frame: 5 years

    Assessment of the presence of predictors of decannulation failure

  2. Time of decannulation and its influence on the weaning process

    Time frame: 5 years

    Investigation if timing of decannulation can influence the result of the tracheostomy weaning process

  3. Shared protocol and clinical score

    Time frame: 5 years

    Possible derivation of a novel clinical score and a shared protocol for decannulation

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Collaborators

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

Registry information

Official study title

WEANING FROM TRACHEOSTOMY: A MULTICENTER, OBSERVATIONAL REVIEW OF PROCEDURES AND PROTOCOLS AND A RESTROSPECTIVE VALIDATION OF THE QSQ SCORING SYSTEM

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 9, 2022
Registry last updated
Sep 10, 2025

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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