Reducing Decannulation Time: Limitation of Decannulation Capping Trials (REDECAP)

Study Overview
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Brief Summary
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Multicenter randomized trial centered on critically-ill tracheostomized patients, comparing two different decannulation protocols: based on capping trials to decide decannulation, based on the aspiration frequency to decide decannulation time. High-flow conditioned oxygen therapy will be applied to all patients through the tracheal cannula. In patients included in the suctioning frequency based protocol along the study period and in patients included in the capping trial protocol along periods out of capping trials.

Official Title
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Reducing Decannulation Time in Critically-ill Tracheostomized Patients: Decannulation Capping Trial Protocol vs Frequency Aspiration Protocol (REDECAP)

Conditions
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Tracheostomy, Airway Management, Respiratory Therapy

Intervention / Treatment
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* Procedure: Decannulation protocol.
* Device: High flow conditioned oxygen therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Critically-ill tracheostomized patients weaned from mechanical ventilation (24 consecutive hours disconnected). Exclusion Criteria: Patients consedered non-decannulable at time of randomization: unconscious patient (motor component of GCS score <6 points). Severe swallowing function (based on drink test). Airway patency problem (based of intolerance of occlusion test). Neuromuscular diseases. Patients with a Sabadell score >2.

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Capping trial protocol<br>Decannulation protocol based on tolerance to 24 hours capping trial to decide when to decannulate. Decapping during the capping trial for aspiration of respiratory secretions is considered a failure criteria of the trial. High flow conditioned oxygen therapy through tracheal cannula will be applied during periods out of capping trials. | |
| Experimental: Suctioning frequency protocol<br>Decannulation protocol based on suctioning frequency to decide when to decannulate (criteria: ≤2 aspirations every 8 h along 24 consecutive hours). Intervention: suctioning frequency of respiratory secretions will be recorded untill fulfill decannulation criteria. Capping trials will not be allowed in this group. High flow conditioned oxygen therapy will be applied through tracheal cannula during all the study period. | Procedure: Decannulation protocol.<br>* Comparison of two different decannulation protocols: one protocol based on capping trial tolerance to decide when to decannulate vs. protocol based on suctioning frequency of respiratory secretions to decide when to decannulate (criteria: ≤2 aspirations every 8 h along 24 consecutive hours).<br>Device: High flow conditioned oxygen therapy<br>* High flow conditioned oxygen therapy will be applied during all study period through tracheal cannula in the experimental arm (suctioning frequency based protocol) and during periods out of capping trials in the control arm (capping trials based protocol).<br>* Other names: OptiflowTM, Fisher&Paykel, Auckland, New Zealand.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decannulation time | Time since weaning from mechanical ventilation (24 consecutive hours disconnected) to decannulation | Patients will be followed for the duration of hospital stay, an expected average of 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decannulation failure | Number of patients requiring recannulation during hospital stay / number of patients included in the group X 100 | Patients will be followed for the duration of hospital stay, an expected average of 3 months | 
| Intensive Care Unit Lenght of stay | Time since ICU admission to ICU discharge | Patients will be followed for the duration of ICU stay, an expected average of 2 months | 
| Hospital lenght of stay | Time since hospital admission to hospital discharge | Patients will be followed for the duration of hospital stay, an expected average of 3 months | 
| ICU mortality | ICU mortality in every study group | Patients will be followed for the duration of ICU stay, an expected average of 2 months | 
| Hospital mortality | Hospital mortality in every study group | Patients will be followed for the duration of hospital stay, an expected average of 3 months | 
| Respiratory infection | Post-randomization pneumonia and tracheobronchitis rate in every study group | Patients will be followed for the duration of hospital stay, an expected average of 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tracheostomy, Decannulation, Adult airway management