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
  Purpose

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).


Condition Intervention Phase
Mechanical Ventilation
Weaning
Other: daily weaning trails
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Automated Ventilator Controlled Weaning to Daily Spontaneous Breathing Trial Weaning Protocol in ICU Patients Following Prolonged Mechanical Ventilation.

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: November 2008
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 SmartCare
automated ventilator controlled adjustment of pressure support
Other: daily weaning trails
daily SmartCare vs SBT until extubation criteria met
Active Comparator: 2 spontaneous breathing Trial
daily SBT on minimum pressure support
Other: daily weaning trails
daily SmartCare vs SBT until extubation criteria met

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813839

Locations
United States, California
San Francisco General Hospital, UCSF Dept. of Anesthesia
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
  More Information

No publications provided

Responsible Party: Jenson Wong MD, Department of Anesthesia, UCSF
ClinicalTrials.gov Identifier: NCT00813839     History of Changes
Other Study ID Numbers: H60971-32402-02
Study First Received: December 19, 2008
Last Updated: March 23, 2011
Health Authority: United States: University of California San Francisco, Committee on Human Research

Keywords provided by University of California, San Francisco:
SmartCare
Spontaneous Breathing Trials
Mechanical Ventilation
Weaning
Patients requiring prolonged mechanical ventilation (>72 hours)

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014