Airway Management, Respiratory Therapy, Tracheostomy
Conditions
Keywords
Tracheostomy, Decannulation, Adult airway management
Brief summary
Multicenter randomized trial centered on critically-ill tracheostomized patients, comparing two different decannulation protocols: 1. based on capping trials to decide decannulation, 2. 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.
Interventions
PROCEDUREDecannulation protocol.
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).
DEVICEHigh flow conditioned oxygen therapy
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).
Sponsors
Hospital Virgen de la Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Critically-ill tracheostomized patients weaned from mechanical ventilation (24 consecutive hours disconnected).
Exclusion criteria
* Patients consedered non-decannulable at time of randomization: 1. unconscious patient (motor component of GCS score \<6 points). 2. Severe swallowing function (based on drink test). 3. Airway patency problem (based of intolerance of occlusion test). 4. Neuromuscular diseases. 5. Patients with a Sabadell score \>2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decannulation time | Patients will be followed for the duration of hospital stay, an expected average of 3 months | Time since weaning from mechanical ventilation (24 consecutive hours disconnected) to decannulation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intensive Care Unit Lenght of stay | Patients will be followed for the duration of ICU stay, an expected average of 2 months | Time since ICU admission to ICU discharge |
| Hospital lenght of stay | Patients will be followed for the duration of hospital stay, an expected average of 3 months | Time since hospital admission to hospital discharge |
| Decannulation failure | Patients will be followed for the duration of hospital stay, an expected average of 3 months | Number of patients requiring recannulation during hospital stay / number of patients included in the group X 100 |
| Hospital mortality | Patients will be followed for the duration of hospital stay, an expected average of 3 months | Hospital mortality in every study group |
| Respiratory infection | Patients will be followed for the duration of hospital stay, an expected average of 3 months | Post-randomization pneumonia and tracheobronchitis rate in every study group |
| ICU mortality | Patients will be followed for the duration of ICU stay, an expected average of 2 months | ICU mortality in every study group |
Countries
Spain
Outcome results
None listed