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

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

Detailed Description
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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.

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

Conditions
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Respiratory Insufficiency, Respiratory Failure

Intervention / Treatment
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* Device: Use of the V60 Mask Ventilator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V60 then Conventional<br>Study device first | Device: Use of the V60 Mask Ventilator<br>* The V60 Mask Ventilator used to provide noninvasive ventilation. It is compared to the patient's conventional ventilator in a cross-over study. The ventilator settings can range from CPAP to Pressure Support ventilation with values of IPAP and EPAP to match the conventional ventilation on which the patient had been placed.<br>* Other names: V60 is the Philips V60 Ventilator;|
| Experimental: Conventional then V60<br>Conventional device first | Device: Use of the V60 Mask Ventilator<br>* The V60 Mask Ventilator used to provide noninvasive ventilation. It is compared to the patient's conventional ventilator in a cross-over study. The ventilator settings can range from CPAP to Pressure Support ventilation with values of IPAP and EPAP to match the conventional ventilation on which the patient had been placed.<br>* Other names: V60 is the Philips V60 Ventilator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breathing Comfort | Comfort on visual analog scale 0 - 100, 0 is best | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Saturation of Arterial Oxygen |  | 30 minutes | 
| Respiratory Rate | Breathing rate in breaths per minute | 30 minutes | 
| Minute Ventilation | Liters per minute that the patient breathes | 30 minutes | 
| Heart Rate | Beats per minute that the patient's heart is beating | 30 minutes | 
| Blood Pressure | Systolic and diastolic blood pressure | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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noninvasive ventilation