Reducing Decannulation Time: Limitation of Decannulation Capping Trials (REDECAP)

Not Applicable

Completed

• Conditions: Tracheostomy; Airway Management; Respiratory Therapy
• Interventions: Procedure: Decannulation protocol.; Device: High flow conditioned oxygen therapy

• Registration Number: NCT02512744
• Lead Sponsor: Hospital Virgen de la Salud

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-27
• Study First Submitted QC: 2015-07-28
• Study First Posted: 2015-07-31
• Study Start: 2016-05-01
• Primary Completion: 2018-05-01
• Study Completion: 2018-05-01
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-06
• Last Update Posted: 2018-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Suctioning frequency protocol	Decannulation 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.
Suctioning frequency protocol	High flow conditioned oxygen therapy	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
ICU mortality	Patients will be followed for the duration of ICU stay, an expected average of 2 months	ICU 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

Trial Locations

Locations (5)

Hospital Universitario Vall D´Ebron; 🇪🇸 Barcelona, Spain

Hospital Del Mar; 🇪🇸 Barcelona, Spain

Hospital Universitario de Ciudad Real; 🇪🇸 Ciudad Real, Spain

Hospital Universitario Ramon Y Cajal; 🇪🇸 Madrid, Spain

Hospital Virgen de La Salud; 🇪🇸 Toledo, Spain