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

Respironics, California, Inc.16 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Respiratory Insufficiency Respiratory Failure

Interventions

noninvasive ventilatorDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

GF-221 Health Sciences Centre

Winnipeg, Manitoba, Canada

Outcomes

Primary Outcomes

Breathing comfort

Time frame: 0, 15, and 30 minutes

Secondary Outcomes

Physiological variables

Time frame: 0, 15, and 30 minutes

Data from ClinicalTrials.gov

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