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Does Deflating the Tracheal Cuff Shorten Weaning Time?

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ClinicalTrials.gov Identifier: NCT00956540
Recruitment Status : Completed
First Posted : August 11, 2009
Results First Posted : September 27, 2011
Last Update Posted : September 27, 2011
Sponsor:
Information provided by (Responsible Party):
Gonzalo Hernandez Martinez, Hospital Virgen de la Salud

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Weaning
Tracheostomy
Interventions Procedure: Deflating tracheal cuff
Procedure: Deflating tracheal cuff 2
Enrollment 195
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Deflating Not Deflating Deflating 2 Not Deflating 2
Hide Arm/Group Description 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. 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 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. 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.
Period Title: Overall Study
Started 54 50 46 45
Completed 51 46 43 41
Not Completed 3 4 3 4
Arm/Group Title Deflating Not Deflating Deflating 2 Not Deflating 2 Total
Hide Arm/Group Description 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. 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 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. 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 of all reporting groups
Overall Number of Baseline Participants 54 50 46 45 195
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 50 participants 46 participants 45 participants 195 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
40
  74.1%
35
  70.0%
44
  95.7%
40
  88.9%
159
  81.5%
>=65 years
14
  25.9%
15
  30.0%
2
   4.3%
5
  11.1%
36
  18.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants 50 participants 46 participants 45 participants 195 participants
56  (16) 58  (19) 56  (16) 58  (19) 57  (17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 50 participants 46 participants 45 participants 195 participants
Female
23
  42.6%
17
  34.0%
16
  34.8%
19
  42.2%
75
  38.5%
Male
31
  57.4%
33
  66.0%
30
  65.2%
26
  57.8%
120
  61.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Spain Number Analyzed 54 participants 50 participants 46 participants 45 participants 195 participants
54 50 46 45 195
1.Primary Outcome
Title Weaning Time
Hide Description 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.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Deflating Not Deflating Deflating 2 Not Deflating 2
Hide Arm/Group Description:
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.
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
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.
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.
Overall Number of Participants Analyzed 55 50 46 44
Mean (Standard Deviation)
Unit of Measure: day
4.95  (5) 10.15  (10) 4.95  (5) 10.15  (10)
2.Secondary Outcome
Title Tracheobronchitis and Pneumonia
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Deflating Not Deflating Deflating 2 Not Deflating 2
Hide Arm/Group Description 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. 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 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. 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.
All-Cause Mortality
Deflating Not Deflating Deflating 2 Not Deflating 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Deflating Not Deflating Deflating 2 Not Deflating 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/54 (18.52%)      16/50 (32.00%)      9/46 (19.57%)      15/45 (33.33%)    
Infections and infestations         
respiratory infection   10/54 (18.52%)  10 16/50 (32.00%)  16 9/46 (19.57%)  9 15/45 (33.33%)  15
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Deflating Not Deflating Deflating 2 Not Deflating 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/54 (0.00%)      0/50 (0.00%)      0/46 (0.00%)      0/45 (0.00%)    
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
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
First Submitted: August 6, 2009
First Posted: August 11, 2009
Results First Submitted: July 1, 2011
Results First Posted: September 27, 2011
Last Update Posted: September 27, 2011