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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.
Randomized controlled trial.
Inclusion criteria: tracheostomized patients for any of the following reasons:
- Prolonged time under mechanical ventilation (>21 days) or prolonged weaning.
- Motor component of Glasgow Coma Score <6 points or inability to adequate manage the airway (>2 aspirations every 8 hours).
- High risk of aspiration (neuromuscular disease affecting bulbar functions, tracheostomy indicated as a part of a surgical protocol involving the upper airway or high risk of aspiration observed after specific evaluation previous to randomization).
- Death before starting weaning attempts.
Study protocol: patients will be randomized after fulfilling standard criteria for weaning initiation and stratified for risk of aspiration. The risk of aspiration will be evaluated using the drink test, and stratified into three categories:
- Low risk (normal drink test).
- Moderate risk (these patients will be included with specific safety considerations, see later).
- High risk patients (spontaneous aspiration of pharyngeal secretions previous to drink test), 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 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 MV 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 MV for at least 24 hours, we will assess his or her preparedness for decannulation. We 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.
- Patients will be considered weaned when remain disconnected from MV for at least 24 hours.
- 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. In all patients a high flow-humidified oxygen-air mixture system will be connected trough the external cannula. In moderate-risk patients a fibrolaryngoscopy will exactly evaluate the risk of aspiration. If confirmed the cannula will be replaced with a subglottic aspiration cannula.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Deflating tracheal cuff, Deflation 2
Hospital Virgen de la Salud
Hospital Virgen de la Salud
Published on BioPortfolio: 2014-07-23T21:13:40-0400
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