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Completed

NCT Number: NCT02512744

Reducing Decannulation Time: Limitation of Decannulation Capping Trials (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.

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Key information

Conditions

Tracheostomy Airway Management Respiratory Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Del Mar, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Critically-ill tracheostomized patients weaned from mechanical ventilation (24 consecutive hours disconnected).

Exclusion criteria

  • 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.

Treatment and study plan

Decannulation protocol.

Procedure

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

Device

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.

Primary outcomes

  1. Decannulation time

    Time frame: 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 outcomes

  1. Decannulation failure

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospital Virgen de la Salud

Other

Registry information

Official study title

Reducing Decannulation Time in Critically-ill Tracheostomized Patients: Decannulation Capping Trial Protocol vs Frequency Aspiration Protocol (REDECAP)

Acronym: REDECAP

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 31, 2015
Registry last updated
Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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