NCT00817804CompletedNot Applicable
Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators for Pediatric Patients With Respiratory Failure or Respiratory Insufficiency
Respironics, California, Inc.2 sites in 1 country3 target enrollmentStarted: January 1, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 3
- Locations
- 2
- Primary Endpoint
- Breathing Comfort
Study Overview
Brief Summary
The purpose of this study is to compare a new noninvasive ventilator to existing ventilators already used for patient care.
Detailed Description
This study compares the Respironics California V60 Mask ventilator to conventional noninvasive ventilators in a cross-over study with the patient as his/her own control.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
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
Outcomes
Primary Outcomes
Breathing Comfort
Time Frame: 30 minutes
Comfort on visual analog scale 0 - 100, 0 is best
Secondary Outcomes
- Saturation of Arterial Oxygen(30 minutes)
- Respiratory Rate(30 minutes)
- Minute Ventilation(30 minutes)
- Heart Rate(30 minutes)
- Blood Pressure(30 minutes)
Investigators
Study Sites (2)
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