Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators
1 other identifier
interventional
16
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2009
CompletedFirst Posted
Study publicly available on registry
January 6, 2009
CompletedStudy Start
First participant enrolled
January 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 7, 2009
CompletedNovember 17, 2017
April 1, 2017
2 months
January 3, 2009
November 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Breathing comfort
0, 15, and 30 minutes
Secondary Outcomes (1)
Physiological variables
0, 15, and 30 minutes
Study Arms (2)
V60 Mask, Then Conventional Mask
OTHERExperimental V60 Mask Ventilator for treating adult patients with COPD, then Comparator Conventional Mask Ventilator for treating adult patients with COPD
Conventional Mask, Then V60 Mask
OTHERComparator Conventional Mask noninvasive Ventilator for treating adult patients with COPD, then Experimental V60 Mask noninvasive Ventilator for treating adult patients with COPD.
Interventions
Experimental V60 Mask noninvasive Ventilator for treating patients with COPD, then Comparator Conventional Mask noninvasive Ventilator for treating patients with COPD in crossover study design
Eligibility Criteria
You may qualify if:
- Age \> 18 years and \< 85 years
- Weight \> 20 kg (44 lbs)
- Respiratory failure or respiratory insufficiency
- Ability to cooperate with the investigators
You may not qualify if:
- An endotracheal tube or tracheostomy in place
- Hemodynamic 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)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Mink, MD
University of Manitoba, Winnipeg, Manitoba, Canada
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Subject was blinded to device identity
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2009
First Posted
January 6, 2009
Study Start
January 17, 2009
Primary Completion
March 3, 2009
Study Completion
April 7, 2009
Last Updated
November 17, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share