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

• Sponsor: Hospital Virgen de la Salud (Other)
• Overall Status: Completed
• CT.gov ID: NCT02512744
• Collaborator: (none)
• Enrollment: 330
• Locations: 5
• Arms: 2
• Actual Duration (Months): 24
• Patients Per Site: 66
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tracheostomy; Airway Management; Respiratory Therapy	Procedure: Decannulation protocol.; Device: High flow conditioned oxygen therapy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 330 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Reducing Decannulation Time in Critically-ill Tracheostomized Patients: Decannulation Capping Trial Protocol vs Frequency Aspiration Protocol (REDECAP)
• Actual Study Start Date: May 1, 2016
• Actual Primary Completion Date: May 1, 2018
• Actual Study Completion Date: May 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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

4. ICU mortality [Patients will be followed for the duration of ICU stay, an expected average of 2 months]

   ICU mortality in every study group

5. Hospital mortality [Patients will be followed for the duration of hospital stay, an expected average of 3 months]

   Hospital mortality in every study group

6. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Del Mar	Barcelona		Spain
2	Hospital Universitario Vall D´Ebron	Barcelona		Spain
3	Hospital Universitario de Ciudad Real	Ciudad Real		Spain
4	Hospital Universitario Ramon Y Cajal	Madrid		Spain
5	Hospital Virgen de La Salud	Toledo		Spain

Sponsors and Collaborators

• Hospital Virgen de la Salud

Investigators

• Study Chair: GONZALO HERNANDEZ, MD, Hospital Virgen de la Salud

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gonzalo Hernandez Martinez, MD, Hospital Virgen de la Salud
• ClinicalTrials.gov Identifier: NCT02512744
• Other Study ID Numbers: 3/7/2015 n67
• First Posted: Jul 31, 2015
• Last Update Posted: Aug 7, 2018
• Last Verified: Aug 1, 2018

• Keywords provided by Gonzalo Hernandez Martinez, MD, Hospital Virgen de la Salud: Tracheostomy; Decannulation; Adult airway management

Study Results

No Results Posted as of Aug 7, 2018