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

Hospital Virgen de la Salud

Status: Completed

Conditions: Airway Management; Respiratory Therapy; Tracheostomy

Treatments: Device: High flow conditioned oxygen therapy; Procedure: Decannulation protocol.

Study type: Interventional

Funder types: Other

Identifiers

NCT02512744

3/7/2015 n67

Details and patient eligibility

About

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.

Enrollment: 330 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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330 participants in 2 patient groups

Capping trial protocol

No Intervention group

Description:

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.

Suctioning frequency protocol

Experimental group

Description:

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.

Treatment:

Procedure: Decannulation protocol.

Device: High flow conditioned oxygen therapy