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Does Deflating the Tracheal Cuff Shorten Weaning Time?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gonzalo Hernandez Martinez, Hospital Virgen de la Salud
ClinicalTrials.gov Identifier:
NCT00956540
First received: August 6, 2009
Last updated: August 19, 2011
Last verified: August 2011

August 6, 2009
August 19, 2011
December 2009
May 2011   (final data collection date for primary outcome measure)
Weaning Time [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The weaning time starts at the first disconnection from mechanical ventilation lasting >30 minutes and ends after the patient tolerate 24 consecutive hours disconnected from mechanical ventilation.
Weaning time [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00956540 on ClinicalTrials.gov Archive Site
Tracheobronchitis and Pneumonia [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Does Deflating the Tracheal Cuff Shorten Weaning Time?
Effect of Deflating the Tracheal Cuff During Ventilatory Disconnections on Weaning Time

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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Weaning
  • Tracheostomy
  • Procedure: Deflating tracheal cuff
    Deflating tracheal cuff during ventilatory disconnections along the weaning phase in patients tracheostomized for prolonged weaning or ventilatory support.
  • Procedure: Deflating tracheal cuff 2
    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.
  • Experimental: Deflating
    Deflating tracheal cuff (total air suction under negative pressure using a syringe) during periods of disconnection from mechanical ventilation in the weaning phase in patients tracheostomized for prolonged weaning or ventilatory support. During ventilatory support the tracheal cuff remain pressurized (30 mmHg).
    Intervention: Procedure: Deflating tracheal cuff
  • No Intervention: Not deflating
    The tracheal cuff remain inflated all the time during the weaning phase in patients tracheostomized for prolonged weaning or ventilatory support
  • Experimental: Deflating 2
    Deflating tracheal cuff during periods of disconnection from mechanical ventilation in the weaning phase in patients tracheostomized for low level of consciousness or inability to adequate mange the airway.
    Intervention: Procedure: Deflating tracheal cuff 2
  • No Intervention: Not deflating 2
    The tracheal cuff remain inflated all the time during the weaning phase in patients tracheostomized for low level of consciousness or inability to adequate mange the airway.
Hernandez G, Pedrosa A, Ortiz R, Cruz Accuaroni Mdel M, Cuena R, Vaquero Collado C, García Plaza S, González Arenas P, Fernandez R. The effects of increasing effective airway diameter on weaning from mechanical ventilation in tracheostomized patients: a randomized controlled trial. Intensive Care Med. 2013 Jun;39(6):1063-70. doi: 10.1007/s00134-013-2870-7. Epub 2013 Mar 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
195
May 2011
May 2011   (final data collection date for primary outcome measure)

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).

Exclusion Criteria:

  • High risk of aspiration (neuromuscular disease affecting bulbar functions, tracheostomies indicated as a part of a surgical procedure involving the upper airway or high risk of aspiration observed after specific evaluation previous to randomization).
  • Death before starting weaning attempts.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00956540
29/06/09-54
Yes
Gonzalo Hernandez Martinez, Hospital Virgen de la Salud
Hospital Virgen de la Salud
Not Provided
Study Chair: Gonzalo Hernandez, MD Hospital Virgen de la Salud
Principal Investigator: Maria del Mar Cruz, MD Hospital Virgen de la Salud
Hospital Virgen de la Salud
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP