Decannulation of Tracheostomy Cannula Based on Suctioning Frequency and High-flow Oxygen Protocol in the Intensive Care Unit

Study Overview
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Brief Summary
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In the DECAP-ICU trial, the investigators will be focusing on the impact of a new weaning tracheostomy technique based on suctioning frequency compared to the standard practice of capping tolerance.

Official Title
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Decannulation of Tracheostomy Cannula Based on Suctioning Frequency and High-flow Oxygen Protocol in the Intensive Care Unit

Conditions
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Tracheostomy Weaning

Intervention / Treatment
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* Procedure: Suctioning based protocol
* Procedure: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Weaning from mechanical ventilation for at least 24 hours Randomisation must be done in 24 hours of the mechanical ventilation weaning. Exclusion Criteria: Sabadell > 2 Contraindication of decannulation : Glasgow Coma Scale <6, severe dysphagia, non permeable respiratory tracks, neuromuscular disease (expect for the ICU weakness) and long term tracheostomy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suction based protocol<br>Weaning protocol based on suctioning frequency. Once the weaning of mechanical ventilation, the patients in this arm will be on high-flow nasal canula. The canula will be remove if the decannulation conditions are met (if the patient require less than 2 aspirations in 8 hours for 24 consecutive hours) | Procedure: Suctioning based protocol<br>* cf. arm The necessity of suctioning will be assed continuously by the nurses, respiratory therapist and the medical team. If the patient require 2 or less aspiration each 8 hours for 24 hours straight, an attempt of decanalution will be done.<br>|
| Other: Usual care<br>Usual care will mainly base on the capping trial. | Procedure: Usual Care<br>* Usual care in our center is tolerance to a capping trial.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to decannulation | Time between the randomisation and the decannulation | Frome date of randomisation to the date of the actual decannulation or to the date of death, whichever comes first, assessed up to 48 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to decannulation criteria | Time between the randomisation and the criteria of decannulation | From date of randomisation to the date when the criteria of decannulation are met or to the date of death, whichever comes first, assessed up to 48 months. | 
| Length of stay ICU | Lenght of stay in the ICU. | From admission to the date when the patient quit the ICU, through study completion, average of 6 to 12 months. | 
| Length of stay hospital | Length of stay in the hospital | From admission to the date when the patient is discharge of the hospital, through study completion, average of 6 to 12 months. | 
| ICU readmission | ICU readmission | Through study completion, average of 6 to 12 months. | 
| Decannulation failure | Necessity of reimplantation of a tracheostomy after the decannulation | Through study completion, average of 6 to 12 months. | 
| Mechanical Ventilation weaning failure | Necessity of starting mechanical ventilation once the randomisation is started | Through study completion, average of 6 to 12 months. | 
| Adverses effects | Pneumonia, sepsis, septic shock | Through study completion, average of 6 to 12 months. | 
| Mortality | All cause mortality | Through study completion, average of 6 to 12 months. |