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)

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 Overview

• Status: Completed
• Conditions: Tracheostomy; Airway Management; Respiratory Therapy
• Intervention / Treatment: Procedure: Decannulation protocol.; Device: High flow conditioned oxygen therapy

• Study Type: Interventional
• Enrollment (Actual): 330
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Hospital del Mar
  • Barcelona, Spain
    • Hospital Universitario Vall D´Ebron
  • Ciudad Real, Spain
    • Hospital Universitario de Ciudad Real
  • Madrid, Spain
    • Hospital Universitario Ramon y Cajal
  • Toledo, Spain
    • Hospital Virgen de la Salud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Capping trial protocol; 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.
Experimental: Suctioning frequency protocol; Decannulation 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.	Procedure: Decannulation 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).; Device: High 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).; Other Names: OptiflowTM, Fisher&Paykel, Auckland, New Zealand.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hospital Virgen de la Salud
• Investigators: Study Chair: Gonzalo Hernandez, MD, Hospital Virgen de la Salud

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: July 27, 2015
• First Submitted That Met QC Criteria: July 28, 2015
• First Posted (Estimate): July 31, 2015

Study Record Updates

• Last Update Posted (Actual): August 7, 2018
• Last Update Submitted That Met QC Criteria: August 6, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Tracheostomy; Decannulation; Adult airway management
• Other Study ID Numbers: 3/7/2015 n67