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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
Results First Received: July 1, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Weaning
Tracheostomy
Interventions: Procedure: Deflating tracheal cuff
Procedure: Deflating tracheal cuff 2

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Deflating The tracheal cuff is deflating during disconnection from mechanical ventilation periods in patients tracheostomized for prolonged weaning or ventilatory support. While patients are connected to mechanical ventilation, the cuff is reinflated.
Not Deflating The tracheal cuff remains inflated during disconnections from mechanical ventilation periods until the patients is definitively liberated from mechanical ventilation in patients tracheostomized for prolonged weaning or ventilatory support
Deflating 2 The tracheal cuff is deflated during disconnections from mechanical ventilation periods in patients tracheostomized for low level of consciousness or inability to adequate mange the airway. The cuff is reinflated when the patients is connected to mechanical ventilation.
Not Deflating 2 The tracheal cuff remains inflated during the weaning period until the patient is definitively liberated from mechanical ventilation in patients tracheostomized for low level of consciousness or inability to adequate manage the airway.

Participant Flow:   Overall Study
    Deflating   Not Deflating   Deflating 2   Not Deflating 2
STARTED   54   50   46   45 
COMPLETED   51   46   43   41 
NOT COMPLETED   3   4   3   4 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Deflating The tracheal cuff is deflating during disconnection from mechanical ventilation periods in patients tracheostomized for prolonged weaning or ventilatory support. While patients are connected to mechanical ventilation, the cuff is reinflated.
Not Deflating The tracheal cuff remains inflated during disconnections from mechanical ventilation periods until the patients is definitively liberated from mechanical ventilation in patients tracheostomized for prolonged weaning or ventilatory support
Deflating 2 The tracheal cuff is deflated during disconnections from mechanical ventilation periods in patients tracheostomized for low level of consciousness or inability to adequate mange the airway. The cuff is reinflated when the patients is connected to mechanical ventilation.
Not Deflating 2 The tracheal cuff remains inflated during the weaning period until the patient is definitively liberated from mechanical ventilation in patients tracheostomized for low level of consciousness or inability to adequate manage the airway.
Total Total of all reporting groups

Baseline Measures
   Deflating   Not Deflating   Deflating 2   Not Deflating 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 54   50   46   45   195 
Age 
[Units: Participants]
         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   40   35   44   40   159 
>=65 years   14   15   2   5   36 
Age 
[Units: Years]
Mean (Standard Deviation)
 56  (16)   58  (19)   56  (16)   58  (19)   57  (17) 
Gender 
[Units: Participants]
         
Female   23   17   16   19   75 
Male   31   33   30   26   120 
Region of Enrollment 
[Units: Participants]
         
Spain   54   50   46   45   195 


  Outcome Measures

1.  Primary:   Weaning Time   [ Time Frame: 6 months ]

2.  Secondary:   Tracheobronchitis and Pneumonia   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Gonzalo Hernández
Organization: Hospital Virgen de la Salud
phone: 0034629625428
e-mail: ghernandezm@telefonica.net


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gonzalo Hernandez Martinez, Hospital Virgen de la Salud
ClinicalTrials.gov Identifier: NCT00956540     History of Changes
Other Study ID Numbers: 29/06/09-54
Study First Received: August 6, 2009
Results First Received: July 1, 2011
Last Updated: August 19, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica