Does Deflating the Tracheal Cuff Shorten Weaning Time?
Condition: Weaning; Tracheostomy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether deflating the tracheal cuff in
      tracheostomized patients, during disconnections from ventilatory support along the weaning
      phase shortens the weaning time.
    

Detailed description: 
      Randomized controlled trial.

      Study protocol: patients will be eligible for the study after fulfilling standard criteria
      for weaning initiation and stratified for risk of aspiration (drink test)into two categories:

        -  Low/moderate risk patients (see later).

        -  High risk patients (spontaneous aspiration of pharyngeal secretions), will be excluded
           from the study.

      After this evaluation patients will be randomized (concealed allocation) stratifying with the
      tracheostomy indication.

      Weaning and Decannulation Protocol: Attempts to discontinue mechanical ventilation (MV) will
      be initiated when the tracheostomized patients fulfill the criteria (recovery from the
      precipitating illness; respiratory criteria consisting of a PaO2/fraction of inspired oxygen
      ratio of >150 mm Hg with a positive end-expiratory pressure <8 cm H2O, and an arterial pH
      >7.32; and clinical criteria consisting of the absence of myocardial ischemia determined by
      ECG, no need for vasoactive drugs or dopamine ≤5 µg/kg/min, a heart rate <140 beats/min,
      haemoglobin concentration >8 g/dL, temperature <38°C, no need for sedative drugs, presence of
      respiratory stimulus and spontaneous cough deemed clinically appropriate. Patients will be
      screened daily for these criteria).

      A clinical algorithm for progressive weaning from mechanical ventilation will be followed at
      the discretion of the attending physician. Patients will be weaned following one of two
      methods: progressive withdrawal of pressure support ventilation or T-tube trials. When
      patients tolerate spontaneous breathing for 12 hours on two consecutive days, they will
      remain connected to the T-tube continuously.

      When the patient remain disconnected from mechanical ventilation for at least 24 hours, the
      investigators will assess his or her preparedness for decannulation. The investigators will
      perform the tracheostomy tube occlusion test to exclude tracheal obstruction to airflow.

      At this point, the attending physician clinically will evaluate the patient's capacity to
      clear respiratory secretions mainly based on the frequency of the need for suctioning and the
      characteristics of respiratory secretions.

      The nurse will suction subglottic secretions while deflating the cuff to avoid the risk of
      aspiration.

      Criteria for decannulation: respiratory secretions management considered adequate (<2
      aspiration every 8 hours) and low risk of aspiration.

      End-points:

        -  Weaning time: starting the day of first disconnection (lasting <30 minutes)and ending
           the day the patient is liberated from mechanical ventilation (patients will be
           considered weaned after 24 consecutive hours disconnected from mechanical ventilation).

        -  Tracheobronchitis and pneumonia after randomization. Safety considerations: The main
           safety concern is the risk of aspiration. First all patients will be categorized in
           three steps using the drink test: low risk patients (normal drink test) with no other
           specific interventions; moderate risk (abnormal drink test) the risk of aspiration study
           will include a videolaryngoscopy; high risk patients will be excluded from the study. In
           all patients a high flow-humidified oxygen-air mixture system will be connected trough
           the external cannula.
    

Intervention name(s): Deflating tracheal cuff; Deflating tracheal cuff 2
Intervention type(s): Procedure; Procedure
Intervention description(s): Deflating tracheal cuff during ventilatory disconnections along the weaning phase in patients tracheostomized for prolonged weaning or ventilatory support.; Deflating tracheal cuff during ventilatory disconnections along the weaning phase in patients tracheostomized for low level of consciousness or inability to adequate manage the airway.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tracheostomy; decannulation; weaning; Tracheostomy Weaning