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

Primary Purpose

Mechanical Ventilation, Weaning

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
daily weaning trails
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mechanical Ventilation focused on measuring SmartCare, Spontaneous Breathing Trials, Mechanical Ventilation, Weaning, Patients requiring prolonged mechanical ventilation (>72 hours)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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  • Patients with neurological injury in whom care is likely to be withdrawn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

Sites / Locations

  • San Francisco General Hospital, UCSF Dept. of Anesthesia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1 SmartCare

2 spontaneous breathing Trial

Arm Description

automated ventilator controlled adjustment of pressure support

daily SBT on minimum pressure support

Outcomes

Primary Outcome Measures

weaning time to successful spontaneous breathing trial
weaning time to successful extubation
ventilator weaning days
total duration of ventilatory support

Secondary Outcome Measures

reintubations within 48 hours
sedation and analgesic requirements
ICU and hospital length of stay
clinical staff time requirements

Full Information

First Posted
December 19, 2008
Last Updated
May 6, 2015
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT00813839
Brief Title
Automated Ventilator Controlled Weaning vs Daily Spontaneous Breathing Trial in Difficult to Wean ICU Patients
Official Title
Comparison of Automated Ventilator Controlled Weaning to Daily Spontaneous Breathing Trial Weaning Protocol in ICU Patients Following Prolonged Mechanical Ventilation.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Withdrawn
Why Stopped
for inability to enroll subjects.
Study Start Date
November 2008 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Ventilation, Weaning
Keywords
SmartCare, Spontaneous Breathing Trials, Mechanical Ventilation, Weaning, Patients requiring prolonged mechanical ventilation (>72 hours)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 SmartCare
Arm Type
Experimental
Arm Description
automated ventilator controlled adjustment of pressure support
Arm Title
2 spontaneous breathing Trial
Arm Type
Active Comparator
Arm Description
daily SBT on minimum pressure support
Intervention Type
Other
Intervention Name(s)
daily weaning trails
Intervention Description
daily SmartCare vs SBT until extubation criteria met
Primary Outcome Measure Information:
Title
weaning time to successful spontaneous breathing trial
Time Frame
28 days or extubation
Title
weaning time to successful extubation
Time Frame
28 days or extubation
Title
ventilator weaning days
Time Frame
28 days or extubation
Title
total duration of ventilatory support
Time Frame
28 days or extubation
Secondary Outcome Measure Information:
Title
reintubations within 48 hours
Time Frame
48 hrs
Title
sedation and analgesic requirements
Time Frame
28 days or extubation
Title
ICU and hospital length of stay
Time Frame
total time of ICU and hospital stay
Title
clinical staff time requirements
Time Frame
during active weaning period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
San Francisco General Hospital, UCSF Dept. of Anesthesia
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States

12. IPD Sharing Statement

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

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