WEANING FROM TRACHEOSTOMY

• Conditions: Tracheostomy Decannulation; Tracheostomy Weaning
• Interventions: Other: Decannulation

• Registration Number: NCT05271786
• Lead Sponsor: University of Milan

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

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-28
• Study First Submitted QC: 2022-02-28
• Last Update Submitted: 2022-02-28
• Study First Posted: 2022-03-09
• Last Update Posted: 2022-03-09
• Study Start: 2022-04-01
• Primary Completion: 2022-10-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tracheostomized patients	Decannulation	Patients who underwent percutaneous tracheostomy performed for any reason

Primary Outcome Measures

Name	Time	Method
QSQ score	5 years	To retrospectively validate a clinical score for weaning from trachesotomy (Quantitative-Semi Quantitative - QSQ )
Standard procedures of decannulation	5 years	To review and compare the standard operating procedures adopted for decannulation at a multicenter level.

Secondary Outcome Measures

Name	Time	Method
Predictors of decannulation failure	5 years	Assessment of the presence of predictors of decannulation failure
Shared protocol and clinical score	5 years	Possible derivation of a novel clinical score and a shared protocol for decannulation
Time of decannulation and its influence on the weaning process	5 years	Investigation if timing of decannulation can influence the result of the tracheostomy weaning process

Trial Locations

Locations (1)

L. Sacco Hospital; 🇮🇹 Milan, Italy