Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators
1 other identifier
interventional
3
1 country
1
Brief Summary
The purpose of this study is to compare a new noninvasive ventilator to existing ventilators already used for patient care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2009
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 3, 2009
CompletedFirst Posted
Study publicly available on registry
January 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
August 12, 2009
CompletedAugust 19, 2009
August 1, 2009
2 months
January 3, 2009
May 5, 2009
August 12, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Breathing Comfort
Comfort on visual analog scale 0 - 100, 0 is best
30 minutes
Secondary Outcomes (5)
Saturation of Arterial Oxygen
30 minutes
Respiratory Rate
30 minutes
Minute Ventilation
30 minutes
Heart Rate
30 minutes
Blood Pressure
30 minutes
Study Arms (2)
V60 then Conventional
EXPERIMENTALStudy device first
Conventional then V60
EXPERIMENTALConventional device first
Interventions
The V60 Mask Ventilator used to provide noninvasive ventilation. It is compared to the patient's conventional ventilator in a cross-over study. The ventilator settings can range from CPAP to Pressure Support ventilation with values of IPAP and EPAP to match the conventional ventilation on which the patient had been placed.
Eligibility Criteria
You may qualify if:
- Age \> 7 years and \< 18 years
- Weight \> 20 kg (44 lbs)
- Respiratory failure or respiratory insufficiency
- Ability to cooperate with the investigators
- Designated adult able to provide Informed Consent
You may not qualify if:
- An endotracheal tube or tracheostomy in place
- Hemodynamically instability
- Prolonged apnea
- Inability to maintain the airway
- A recent history of cardiac and or respiratory arrest
- Acute hemorrhage
- Multiple organ system failure
- Undrained pneumothorax
- High risk for aspiration
- Metastatic or terminal cancer
- Do-not-resuscitate orders
- Inability to clear respiratory secretions
- Inability to fit a mask
- Facial surgery, trauma, or deformity
- Upper gastrointestinal or airway surgery
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
GF-221 Health Sciences Centre
Winnipeg, Manitoba, R3E 0Z3, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Terminated before 20 patients enrolled
Results Point of Contact
- Title
- Adam Seiver
- Organization
- Respironics California
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Mink, MD
University of Manitoba, Winnipeg, Manitoba, Canada
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 3, 2009
First Posted
January 6, 2009
Study Start
January 1, 2009
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
August 19, 2009
Results First Posted
August 12, 2009
Record last verified: 2009-08