Trial Outcomes & Findings for Does Deflating the Tracheal Cuff Shorten Weaning Time? (NCT NCT00956540)

NCT ID: NCT00956540

Last Updated: 2011-09-27

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 195 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2011-09-27

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	54	50	46	45
Overall Study COMPLETED	51	46	43	41
Overall Study NOT COMPLETED	3	4	3	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Does Deflating the Tracheal Cuff Shorten Weaning Time?

Baseline characteristics by cohort

Measure	Deflating n=54 Participants 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 n=50 Participants 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 n=46 Participants 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 n=45 Participants 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 n=195 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants	35 Participants n=7 Participants	44 Participants n=5 Participants	40 Participants n=4 Participants	159 Participants n=21 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	15 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	36 Participants n=21 Participants
Age Continuous	56 years STANDARD_DEVIATION 16 • n=5 Participants	58 years STANDARD_DEVIATION 19 • n=7 Participants	56 years STANDARD_DEVIATION 16 • n=5 Participants	58 years STANDARD_DEVIATION 19 • n=4 Participants	57 years STANDARD_DEVIATION 17 • n=21 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	17 Participants n=7 Participants	16 Participants n=5 Participants	19 Participants n=4 Participants	75 Participants n=21 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	33 Participants n=7 Participants	30 Participants n=5 Participants	26 Participants n=4 Participants	120 Participants n=21 Participants
Region of Enrollment Spain	54 participants n=5 Participants	50 participants n=7 Participants	46 participants n=5 Participants	45 participants n=4 Participants	195 participants n=21 Participants

PRIMARY outcome

Timeframe: 6 months

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.

Outcome measures

Measure	Deflating n=55 Participants 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 n=50 Participants 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 n=46 Participants 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 n=44 Participants 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.
Weaning Time	4.95 day Standard Deviation 5	10.15 day Standard Deviation 10	4.95 day Standard Deviation 5	10.15 day Standard Deviation 10

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

Adverse Events

Deflating

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

Not Deflating

Serious events: 16 serious events

Other events: 0 other events

Deaths: 0 deaths

Deflating 2

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Not Deflating 2

Serious events: 15 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Deflating n=54 participants at risk 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 n=50 participants at risk 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 n=46 participants at risk 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 n=45 participants at risk 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.
Infections and infestations respiratory infection	18.5% 10/54 • Number of events 10	32.0% 16/50 • Number of events 16	19.6% 9/46 • Number of events 9	33.3% 15/45 • Number of events 15

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gonzalo Hernández

Hospital Virgen de la Salud

Phone: 0034629625428

Email: ghernandezm@telefonica.net

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place