- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00813839
Automated Ventilator Controlled Weaning vs Daily Spontaneous Breathing Trial in Difficult to Wean ICU Patients
May 6, 2015 updated by: University of California, San Francisco
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).
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94110
- San Francisco General Hospital, UCSF Dept. of Anesthesia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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- Patients with neurological injury in whom care is likely to be withdrawn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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1 SmartCare
automated ventilator controlled adjustment of pressure support
|
daily SmartCare vs SBT until extubation criteria met
|
Active Comparator: 2 spontaneous breathing Trial
daily SBT on minimum pressure support
|
daily SmartCare vs SBT until extubation criteria met
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
weaning time to successful spontaneous breathing trial
Time Frame: 28 days or extubation
|
28 days or extubation
|
weaning time to successful extubation
Time Frame: 28 days or extubation
|
28 days or extubation
|
ventilator weaning days
Time Frame: 28 days or extubation
|
28 days or extubation
|
total duration of ventilatory support
Time Frame: 28 days or extubation
|
28 days or extubation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
reintubations within 48 hours
Time Frame: 48 hrs
|
48 hrs
|
sedation and analgesic requirements
Time Frame: 28 days or extubation
|
28 days or extubation
|
ICU and hospital length of stay
Time Frame: total time of ICU and hospital stay
|
total time of ICU and hospital stay
|
clinical staff time requirements
Time Frame: during active weaning period
|
during active weaning period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
December 19, 2008
First Submitted That Met QC Criteria
December 22, 2008
First Posted (Estimate)
December 23, 2008
Study Record Updates
Last Update Posted (Estimate)
May 8, 2015
Last Update Submitted That Met QC Criteria
May 6, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H60971-32402-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mechanical Ventilation
-
Thammasat UniversityCompletedProlonged Mechanical Ventilation | Home Mechanical VentilationThailand
-
Academisch Medisch Centrum - Universiteit van Amsterdam...University of Zurich; Dijklander Ziekenhuis; Reinier de Graaf GroepCompletedMechanical Ventilation | Mechanical PowerNetherlands
-
JOSE IVAN RODRIGUEZ DE MOLINA SERRANOCompletedMechanical Ventilation Complication | Mechanical Power | Driving Pressure | Lung Protective VentilationMexico
-
Rabin Medical CenterUnknownMechanical Ventilation | Weaning | Prolonged Ventilation
-
Drägerwerk AG & Co. KGaAUniversity of Göttingen; Prof. Dr. med. ImhoffSuspendedMechanical Ventilation | Ventilation Perfusion MismatchGermany
-
Capital Medical UniversityRecruitingMechanical VentilationChina
-
University of ChicagoActive, not recruitingMechanical VentilationUnited States
-
Chang Gung UniversityCompleted
-
The University of Texas Health Science Center,...Edwards LifesciencesWithdrawnMechanical VentilationUnited States
-
Bursa Yüksek İhtisas Education and Research HospitalCompletedthe Effect of Different Mechanical Ventilation Modes on Optic Nerve Diameter and Conscious FunctionsMechanical VentilationTurkey
Clinical Trials on daily weaning trails
-
Thomas Jefferson UniversityCompletedSatisfaction | Adherence, Patient | MotivationUnited States
-
University of Missouri-ColumbiaTerminated
-
Felix JF HerthDLR German Aerospace Center; University Hospital Heidelberg; Federal Joint Committee and other collaboratorsRecruitingWeaning | Invasive VentilationGermany
-
BDH-Klinik Hessisch OldendorfCompletedRespiratory Insufficiency | Neurologic DisorderGermany
-
Federal University of UberlandiaCompletedWeaning Failure | Complication of Respirator [Ventilator]Brazil
-
University Hospital TuebingenNot yet recruitingAcute Respiratory Distress Syndrome
-
Jianfeng XieUnknownMechanical Ventilation | Weaning | Intensive Care MedicineChina
-
The University of Texas Health Science Center,...CompletedRespiratory Distress Syndrome | Apnea of PrematurityUnited States
-
Fundación para la Investigación del Hospital Clínico...Completed
-
Johan Fridolf HermansenCompletedAcute Kidney Injury | Acute Kidney Failure Stage 3Denmark