Clinical trial NCT02512744: Reducing Decannulation Time: Limitation of Decannulation Capping Trials (REDECAP)
Official title: Reducing Decannulation Time in Critically-ill Tracheostomized Patients: Decannulation Capping Trial Protocol vs Frequency Aspiration Protocol (REDECAP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheostomy
Airway Management
Respiratory Therapy
Keywords: Tracheostomy
Decannulation
Adult airway management
Lead sponsor: Hospital Virgen de la Salud
Sponsor class: OTHER
First posted: 2015-07-31
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Decannulation time
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 3 months
Secondary outcomes:
measure: Decannulation failure
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 3 months
measure: Intensive Care Unit Lenght of stay
timeFrame: Patients will be followed for the duration of ICU stay, an expected average of 2 months
measure: Hospital lenght of stay
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 3 months
measure: ICU mortality
timeFrame: Patients will be followed for the duration of ICU stay, an expected average of 2 months
measure: Hospital mortality
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 3 months
measure: Respiratory infection
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 3 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Del Mar
city: Barcelona
country: Spain
facility: Hospital Universitario Vall D´Ebron
city: Ciudad Real
country: Spain
facility: Hospital Universitario de Ciudad Real
city: Madrid
country: Spain
facility: Hospital Universitario Ramon Y Cajal
city: Toledo
country: Spain
facility: Hospital Virgen de La Salud
Study officials:
affiliation: Hospital Virgen de la Salud
name: GONZALO HERNANDEZ, MD
role: STUDY_CHAIR
References:
citation: 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.