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

Mechanical Ventilation Clinical Trial

Official title:

Comparison of Automated Ventilator Controlled Weaning to Daily Spontaneous Breathing Trial Weaning Protocol in ICU Patients Following Prolonged Mechanical Ventilation.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00813839
• Other study ID #: H60971-32402-02
• Status: Withdrawn
• Phase: Phase 4
• First received: December 19, 2008
• Last updated: May 6, 2015
• Start date: November 2008
• Est. completion date: October 2011

Study information

• Verified date: May 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: University of California San Francisco, Committee on Human Research
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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• Patients with neurological injury in whom care is likely to be withdrawn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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mechanical Ventilation
• Weaning

Intervention

Other:
• daily weaning trails
daily SmartCare vs SBT until extubation criteria met

Locations

Country	Name	City	State
United States	San Francisco General Hospital, UCSF Dept. of Anesthesia	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weaning time to successful spontaneous breathing trial		28 days or extubation	No
Primary	weaning time to successful extubation		28 days or extubation	No
Primary	ventilator weaning days		28 days or extubation	No
Primary	total duration of ventilatory support		28 days or extubation	No
Secondary	reintubations within 48 hours		48 hrs	Yes
Secondary	sedation and analgesic requirements		28 days or extubation	Yes
Secondary	ICU and hospital length of stay		total time of ICU and hospital stay	No
Secondary	clinical staff time requirements		during active weaning period	No