Reducing Decannulation Time: Limitation of Decannulation Capping Trials (REDECAP)
REDECAP
Reducing Decannulation Time in Critically-ill Tracheostomized Patients: Decannulation Capping Trial Protocol vs Frequency Aspiration Protocol (REDECAP)
1 other identifier
interventional
330
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2016
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2015
CompletedFirst Posted
Study publicly available on registry
July 31, 2015
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedAugust 7, 2018
August 1, 2018
2 years
July 27, 2015
August 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Decannulation failure
Patients will be followed for the duration of hospital stay, an expected average of 3 months
Intensive Care Unit Lenght of stay
Patients will be followed for the duration of ICU stay, an expected average of 2 months
Hospital lenght of stay
Patients will be followed for the duration of hospital stay, an expected average of 3 months
ICU mortality
Patients will be followed for the duration of ICU stay, an expected average of 2 months
Hospital mortality
Patients will be followed for the duration of hospital stay, an expected average of 3 months
- +1 more secondary outcomes
Study Arms (2)
Capping trial protocol
NO INTERVENTIONDecannulation 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
EXPERIMENTALDecannulation 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.
Interventions
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).
Eligibility Criteria
You may qualify if:
- Critically-ill tracheostomized patients weaned from mechanical ventilation (24 consecutive hours disconnected).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
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
Related Publications (1)
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.
PMID: 32905673DERIVED
Study Officials
- STUDY CHAIR
GONZALO HERNANDEZ, MD
Hospital Virgen de la Salud
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
July 27, 2015
First Posted
July 31, 2015
Study Start
May 1, 2016
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
August 7, 2018
Record last verified: 2018-08