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

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

Study Overview

• Status: Completed
• Conditions: Respiratory Failure; Respiratory Insufficiency
• Intervention / Treatment: Device: noninvasive ventilator

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0Z3
      • GF-221 Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: V60 Mask, Then Conventional Mask; Experimental V60 Mask Ventilator for treating adult patients with COPD, then Comparator Conventional Mask Ventilator for treating adult patients with COPD	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
Other: Conventional Mask, Then V60 Mask; 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; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Respironics, California, Inc.
• Investigators: Principal Investigator: Steven Mink, MD, University of Manitoba, Winnipeg, Manitoba, Canada

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2009
• Primary Completion (Actual): March 3, 2009
• Study Completion (Actual): April 7, 2009

Study Registration Dates

• First Submitted: January 3, 2009
• First Submitted That Met QC Criteria: January 5, 2009
• First Posted (Estimate): January 6, 2009

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 13, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: noninvasive ventilation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: V60-1050767VP v 2.4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No