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

Not Applicable

Completed

• Conditions: Respiratory Failure; Respiratory Insufficiency
• Interventions: Device: noninvasive ventilator

• Registration Number: NCT00817297
• Lead Sponsor: Respironics, California, Inc.

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2009-01-03
• Study First Submitted QC: 2009-01-05
• Study First Posted: 2009-01-06
• Study Start: 2009-01-17
• Primary Completion: 2009-03-03
• Study Completion: 2009-04-07
• Status Verified: 2017-04
• Last Update Submitted: 2017-11-13
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
V60 Mask, Then Conventional Mask	noninvasive ventilator	Experimental V60 Mask Ventilator for treating adult patients with COPD, then Comparator Conventional Mask Ventilator for treating adult patients with COPD
Conventional Mask, Then V60 Mask	noninvasive ventilator	Comparator Conventional Mask noninvasive Ventilator for treating adult patients with COPD, then Experimental V60 Mask noninvasive Ventilator for treating adult patients with COPD.

Primary Outcome Measures

Name	Time	Method
Breathing comfort	0, 15, and 30 minutes

Secondary Outcome Measures

Name	Time	Method
Physiological variables	0, 15, and 30 minutes

Trial Locations

Locations (1)

GF-221 Health Sciences Centre; 🇨🇦 Winnipeg, Manitoba, Canada