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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
330
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).
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).
Hospital Del Mar
Barcelona, Spain
Hospital Universitario Vall D´Ebron
Barcelona, Spain
Hospital Universitario de Ciudad Real
Ciudad Real, Spain
Hospital Universitario Ramon Y Cajal
Madrid, Spain
Hospital Virgen de La Salud
Toledo, Spain
Decannulation time
Time since weaning from mechanical ventilation (24 consecutive hours disconnected) to decannulation
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 3 months
Decannulation failure
Number of patients requiring recannulation during hospital stay / number of patients included in the group X 100
Time frame: 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
Time frame: 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
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 3 months
ICU mortality
ICU mortality in every study group
Time frame: Patients will be followed for the duration of ICU stay, an expected average of 2 months
Hospital mortality
Hospital mortality in every study group
Time frame: 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
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.