N/A
N=3
Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators
Respiratory Insufficiency · Respiratory Failure
Bottom Line
View on ClinicalTrials.gov: NCT00817804 ↗Enrolled (actual)
3
Serious AEs
—
Results posted
Aug 2009
Primary outcome: Primary: Breathing Comfort — 10; 40; 33.3; 45 visual analog scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Use of the V60 Mask Ventilator (Device)
- Age
- Pediatric, Adult · 7+ yrs
- Sex
- All
- Sponsor
- Respironics, California, Inc.
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Breathing Comfort |
10; 40; 33.3; 45 | — |
| SECONDARY Saturation of Arterial Oxygen |
— | — |
| SECONDARY Respiratory Rate |
— | — |
| SECONDARY Minute Ventilation |
— | — |
| SECONDARY Heart Rate |
— | — |
| SECONDARY Blood Pressure |
— | — |
Summary
The purpose of this study is to compare a new noninvasive ventilator to existing ventilators already used for patient care.
Eligibility Criteria
Inclusion Criteria
- Age > 7 years and 20 kg (44 lbs)
- Respiratory failure or respiratory insufficiency
- Ability to cooperate with the investigators
- Designated adult able to provide Informed Consent
Exclusion Criteria
- 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
- Pregnancy
- Refractory delirium
- PaO2 < 50 mmHg on present settings
- Designee unable or unwilling to provide Informed Consent
Data sourced from ClinicalTrials.gov (NCT00817804). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.