Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators

Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators for Pediatric Patients With Respiratory Failure or Respiratory Insufficiency

The purpose of this study is to compare a new noninvasive ventilator to existing ventilators already used for patient care.

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.

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