- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05271786
WEANING FROM TRACHEOSTOMY
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
Conditions
Intervention / Treatment
Detailed Description
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.
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
- Patients >18 years old
- Percutaneous tracheostomy performed for any reason
- 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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
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Milan, Italy, 20157
- L. Sacco Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients >18 years old
- Percutaneous tracheostomy performed for any reason
- 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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- OR022022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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