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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The primary objective of this study was to compare the performance (i.e., patient self-reported Comfort score) of the V60 device and a conventional noninvasive ventilator (patient's current ventilator). For the User Needs Assessment, the primary objective of the study was to validate the V60 to user needs. All patients were volunteers from the Respiratory Section of the Health Sciences Centre at the University of Manitoba. The study utilized a randomized 2-period cross-over study design to compare the V60 System to the patients' existing conventional noninvasive ventilator in different ventilation modes.

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

Conditions
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Respiratory Insufficiency, Respiratory Failure

Intervention / Treatment
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* Device: noninvasive ventilator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years and < 85 years Weight > 20 kg (44 lbs) Respiratory failure or respiratory insufficiency Ability to cooperate with the investigators Exclusion Criteria: An endotracheal tube or tracheostomy in place Hemodynamic 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 Inability or unwillingness to provide Informed Consent PaO2 < 50 mmHg

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: V60 Mask, Then Conventional Mask<br>Experimental V60 Mask Ventilator for treating adult patients with COPD, then Comparator Conventional Mask Ventilator for treating adult patients with COPD | Device: noninvasive ventilator<br>* Experimental V60 Mask noninvasive Ventilator for treating patients with COPD, then Comparator Conventional Mask noninvasive Ventilator for treating patients with COPD in crossover study design<br>|
| Other: Conventional Mask, Then V60 Mask<br>Comparator Conventional Mask noninvasive Ventilator for treating adult patients with COPD, then Experimental V60 Mask noninvasive Ventilator for treating adult patients with COPD. | Device: noninvasive ventilator<br>* Experimental V60 Mask noninvasive Ventilator for treating patients with COPD, then Comparator Conventional Mask noninvasive Ventilator for treating patients with COPD in crossover study design<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breathing comfort |  | 0, 15, and 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological variables |  | 0, 15, and 30 minutes | 

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