WEANING FROM TRACHEOSTOMY

February 28, 2022 updated by: Pierachille Santus, MD, PhD, University of Milan

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

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.

Study Overview

Status

Not yet recruiting

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Milan, Italy, 20157
        • L. Sacco Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Tracheostomized patients
Patients who underwent percutaneous tracheostomy performed for any reason
retrospective evaluation of decannulation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictors of decannulation failure
Time Frame: 5 years
Assessment of the presence of predictors of decannulation failure
5 years
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
5 years
Shared protocol and clinical score
Time Frame: 5 years
Possible derivation of a novel clinical score and a shared protocol for decannulation
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

February 28, 2022

First Submitted That Met QC Criteria

February 28, 2022

First Posted (Actual)

March 9, 2022

Study Record Updates

Last Update Posted (Actual)

March 9, 2022

Last Update Submitted That Met QC Criteria

February 28, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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