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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

December 19, 2008
March 23, 2011
November 2008
October 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00813839 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Automated Ventilator Controlled Weaning vs Daily Spontaneous Breathing Trial in Difficult to Wean ICU Patients
Comparison of Automated Ventilator Controlled Weaning to Daily Spontaneous Breathing Trial Weaning Protocol in ICU Patients Following Prolonged Mechanical Ventilation.

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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Mechanical Ventilation
  • Weaning
Other: daily weaning trails
daily SmartCare vs SBT until extubation criteria met
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
100
October 2011
October 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00813839
H60971-32402-02
No
Jenson Wong MD, Department of Anesthesia, UCSF
University of California, San Francisco
Not Provided
Not Provided
University of California, San Francisco
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP