Mechanical VentilationPhase 4NCT00813839
Automated Ventilator Controlled Weaning vs Daily Spontaneous Breathing Trial in Difficult to Wean ICU Patients
A Phase 4 study testing daily weaning trails in people with Mechanical Ventilation and Weaning, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Weaning
- What is being tested?
- daily weaning trails
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Oct 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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- Patients with neurological injury in whom care is likely to be withdrawn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.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco General Hospital, UCSF Dept. of Anesthesia
San Francisco, California, 94110
About this study
Official title: 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).
- Conditions
- Mechanical Ventilation, Weaning
- Being tested
- daily weaning trails
- Keywords
- SmartCare, Spontaneous Breathing Trials, Mechanical Ventilation, Weaning, Patients requiring prolonged mechanical ventilation (>72 hours)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
daily weaning trailsOther
daily SmartCare vs SBT until extubation criteria met
| Study group | Role | What they receive |
|---|---|---|
| 1 SmartCare | Experimental | automated ventilator controlled adjustment of pressure support Receives: Other: daily weaning trails |
| 2 spontaneous breathing Trial | Active comparator | daily SBT on minimum pressure support Receives: Other: daily weaning trails |
What is being measured
The primary outcome is the main question the study is designed to answer.
weaning time to successful spontaneous breathing trial
Measured: 28 days or extubation
weaning time to successful extubation
Measured: 28 days or extubation
ventilator weaning days
Measured: 28 days or extubation
total duration of ventilatory support
Measured: 28 days or extubation
Secondary outcomes (4)
reintubations within 48 hours
Measured: 48 hrs
sedation and analgesic requirements
Measured: 28 days or extubation
ICU and hospital length of stay
Measured: total time of ICU and hospital stay
clinical staff time requirements
Measured: during active weaning period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionOct 2011
- Study completionOct 2011
Why it stopped: for inability to enroll subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813839
- Sponsor's protocol ID
- H60971-32402-02
- Status last verified
- May 2015
- First submitted
- 19 Dec 2008
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Automated Ventilator Controlled Weaning to Daily Spontaneous Breathing Trial Weaning Protocol in ICU Patients Following Prolonged Mechanical Ventilation.
- ClinicalTrials.gov ID
- NCT00813839
- Acronym / sponsor ID
- H60971-32402-02
- Conditions
- Mechanical Ventilation, Weaning
- Keywords
- SmartCare, Spontaneous Breathing Trials, Mechanical Ventilation, Weaning, Patients requiring prolonged mechanical ventilation (>72 hours)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: for inability to enroll subjects.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 23 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 SmartCare | Experimental | Other: daily weaning trailsautomated ventilator controlled adjustment of pressure support |
| 2 spontaneous breathing Trial | Active comparator | Other: daily weaning trailsdaily SBT on minimum pressure support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| daily weaning trailsdaily SmartCare vs SBT until extubation criteria met | Other | 1 SmartCare, 2 spontaneous breathing Trial |
Primary outcome
weaning time to successful spontaneous breathing trial
Time frame: 28 days or extubation
weaning time to successful extubation
Time frame: 28 days or extubation
ventilator weaning days
Time frame: 28 days or extubation
total duration of ventilatory support
Time frame: 28 days or extubation
4 secondary outcomes
reintubations within 48 hours
Time frame: 48 hrs
sedation and analgesic requirements
Time frame: 28 days or extubation
ICU and hospital length of stay
Time frame: total time of ICU and hospital stay
clinical staff time requirements
Time frame: during active weaning period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing daily weaning trails in people with Mechanical Ventilation and Weaning, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weaning time to successful spontaneous breathing trial (time frame: 28 days or extubation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2015.