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

History of Changes

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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.

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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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
Number of Participants [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 ]

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2. Secondary:

Tracheobronchitis and Pneumonia [ Time Frame: 6 months ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

Serious Adverse Events

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Other Adverse Events

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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.

Limitations and Caveats

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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Results Point of Contact:

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

No publications provided

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

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