Automated Ventilator Controlled Weaning vs Daily Spontaneous Breathing Trial in Difficult to Wean ICU Patients

This study has suspended participant recruitment.

(for low recruitment and enrollment of subjects.)

Sponsor:

Information provided by:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT00813839

First received: December 19, 2008

Last updated: March 23, 2011

Last verified: March 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	December 19, 2008
Last Updated Date	March 23, 2011
Start Date ^ICMJE	November 2008
Estimated Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 22, 2008)	weaning time to successful spontaneous breathing trial [ Time Frame: 28 days or extubation ] [ Designated as safety issue: No ] weaning time to successful extubation [ Time Frame: 28 days or extubation ] [ Designated as safety issue: No ] ventilator weaning days [ Time Frame: 28 days or extubation ] [ Designated as safety issue: No ] total duration of ventilatory support [ Time Frame: 28 days or extubation ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00813839 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 22, 2008)	reintubations within 48 hours [ Time Frame: 48 hrs ] [ Designated as safety issue: Yes ] sedation and analgesic requirements [ Time Frame: 28 days or extubation ] [ Designated as safety issue: Yes ] ICU and hospital length of stay [ Time Frame: total time of ICU and hospital stay ] [ Designated as safety issue: No ] clinical staff time requirements [ Time Frame: during active weaning period ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Automated Ventilator Controlled Weaning vs Daily Spontaneous Breathing Trial in Difficult to Wean ICU Patients
Official Title ^ICMJE	Comparison of Automated Ventilator Controlled Weaning to Daily Spontaneous Breathing Trial Weaning Protocol in ICU Patients Following Prolonged Mechanical Ventilation.
Brief Summary	This study will compare Drager Smart Care (SC), a commercially available automated ventilator controlled weaning mode to the current daily spontaneous breathing trial (SBT) weaning protocol. The study is designed to determine if automated ventilator controlled weaning can reduce total duration of intubation following mechanical ventilation in ICU patients requiring prolonged mechanical ventilation (>72 hours).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Mechanical Ventilation Weaning
Intervention ^ICMJE	Other: daily weaning trails daily SmartCare vs SBT until extubation criteria met
Study Arm (s)	Experimental: 1 SmartCare automated ventilator controlled adjustment of pressure support Intervention: Other: daily weaning trails Active Comparator: 2 spontaneous breathing Trial daily SBT on minimum pressure support Intervention: Other: daily weaning trails
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Suspended
Estimated Enrollment ^ICMJE	100
Estimated Completion Date	October 2011
Estimated Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Age ≥ 18 years Intubated with endotracheal tube Requiring mechanical ventilation for > 72 hours Meets weaning criteria: Improvement or resolution of the underlying process that precipitated need for mechanical ventilation, PaO2 ≥ 60 mm Hg on PEEP and FiO2 Requirements of ≤ 8 cm H2O and FiO2 ≤ 0.50, Stable oxygenation: PEEP and FiO2 requirements not increased in the past 24 hrs, Ability to initiate an inspiratory effort and trigger the ventilator, Subject enrollment approved by the primary service attending physician Exclusion Criteria: Pregnancy Patients with tracheostomy or planned tracheostomy prior to attempt to extubate Patients with known airway patency issues that are anticipated to delay extubation. Patients with neurological injury in whom care is likely to be withdrawn Patients with cervical spinal cord injury. Prospective subject or surrogate consenter does not fully understand the implications of the study because of a language barrier.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00813839
Other Study ID Numbers ^ICMJE	H60971-32402-02
Has Data Monitoring Committee	No
Responsible Party	Jenson Wong MD, Department of Anesthesia, UCSF
Study Sponsor ^ICMJE	University of California, San Francisco
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of California, San Francisco
Verification Date	March 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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