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Multicenter randomized trial centered on critically-ill tracheostomized patients, comparing two different decannulation protocols:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capping trial protocol | No Intervention | 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. | |
| Suctioning frequency protocol | Experimental | Decannulation protocol based on suctioning frequency to decide when to decannulate (criteria: ā¤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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decannulation protocol. | Procedure | 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: ā¤2 aspirations every 8 h along 24 consecutive hours). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Patients consedered non-decannulable at time of randomization:
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| Name | Affiliation | Role |
|---|---|---|
| GONZALO HERNANDEZ, MD | Hospital Virgen de la Salud | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Del Mar | Barcelona | Spain | ||||
| Hospital Universitario Vall DĀ“Ebron |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32905673 | Derived | Hernandez Martinez G, Rodriguez ML, Vaquero MC, Ortiz R, Masclans JR, Roca O, Colinas L, de Pablo R, Espinosa MD, Garcia-de-Acilu M, Climent C, Cuena-Boy R. High-Flow Oxygen with Capping or Suctioning for Tracheostomy Decannulation. N Engl J Med. 2020 Sep 10;383(11):1009-1017. doi: 10.1056/NEJMoa2010834. |
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| High flow conditioned oxygen therapy | Device | 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). |
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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 |
| Barcelona |
| Spain |
| Hospital Universitario de Ciudad Real | Ciudad Real | Spain |
| Hospital Universitario Ramon Y Cajal | Madrid | Spain |
| Hospital Virgen de La Salud | Toledo | Spain |