Clinical trial NCT05271786: WEANING FROM TRACHEOSTOMY
Official title: WEANING FROM TRACHEOSTOMY: A MULTICENTER, OBSERVATIONAL REVIEW OF PROCEDURES AND PROTOCOLS AND A RESTROSPECTIVE VALIDATION OF THE QSQ SCORING SYSTEM
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tracheostomy Weaning
Tracheostomy Decannulation
Keywords: tracheostomy weaning
tracheostomy decannulation
Quantitative-Semi Quantitative - QSQ
Lead sponsor: University of Milan
Sponsor class: OTHER
Collaborators: name: Dejan Radovanovic
name: Marina Gatti
name: Michele Mondoni
name: Stefano Centanni
name: Frascesco Blasi
name: Andrea Gramegna
name: Fabiano Di Marco
name: Stefano Aliberti
name: Humanitas Research Hospital IRCCS, Rozzano-Milan
name: Ca' Granda Policlinico Milano
name: ASST Santi Paolo e Carlo
name: Ospedale Luigi Sacco Milano
name: Papa Giovanni XXIII Bergamo
First posted: 2022-03-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent a tracheostomy procedure and decannulation during their hospital stay since January 2017 until November 2021.

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.

Detailed description: The study will have two co-primary objectives:

1. To review and compare the standard operating procedures adopted for decannulation at a multicenter level.
2. 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.

We 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

1. Patients \>18 years old
2. Percutaneous tracheostomy performed for any reason
3. At least one decannulation attempt during the hospitalization period. Exclusion criteria

1. 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

Eligibility criteria: Inclusion Criteria:

1. Patients \>18 years old
2. Percutaneous tracheostomy performed for any reason
3. At least one decannulation attempt during the hospitalization period.

Exclusion Criteria:

1. 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

Primary outcomes:
measure: Standard procedures of decannulation
timeFrame: 5 years
measure: QSQ score
timeFrame: 5 years
Secondary outcomes:
measure: Predictors of decannulation failure
timeFrame: 5 years
measure: Time of decannulation and its influence on the weaning process
timeFrame: 5 years
measure: Shared protocol and clinical score
timeFrame: 5 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: L. Sacco Hospital
Study officials:
References: