Status:
COMPLETED
Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators
Lead Sponsor:
Respironics, California, Inc.
Conditions:
Respiratory Insufficiency
Respiratory Failure
Eligibility:
All Genders
7-18 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00817804
Start Date
January 1 2009
End Date
March 1 2009
Last Update
August 19 2009
Active Locations (1)
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1
GF-221 Health Sciences Centre
Winnipeg, Manitoba, Canada, R3E 0Z3