NCT00817297

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 Adult Patients With Respiratory Failure or Respiratory Insufficiency

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Respironics, California, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Insufficiency
• Respiratory Failure

Interventions

Type	Name	Description
DEVICE	noninvasive ventilator	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

Timeline

• Start date: 2009-01-17
• Primary completion: 2009-03-03
• Completion: 2009-04-07
• First posted: 2009-01-06
• Last updated: 2017-11-17

Locations

1 site across 1 country: Canada