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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Respironics, California, Inc.
ClinicalTrials.gov Identifier:
NCT00817297
First received: January 3, 2009
Last updated: April 17, 2017
Last verified: April 2017
  Purpose
The purpose of this study is to compare a new noninvasive ventilator to existing ventilators already used for patient care.

Condition Intervention
Respiratory Insufficiency
Respiratory Failure
Device: noninvasive ventilator

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant
Masking Description:
Subject was blinded to device identity
Primary Purpose: Treatment
Official Title: Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators for Adult Patients With Respiratory Failure or Respiratory Insufficiency

Resource links provided by NLM:


Further study details as provided by Respironics, California, Inc.:

Primary Outcome Measures:
  • Breathing comfort [ Time Frame: 0, 15, and 30 minutes ]

Secondary Outcome Measures:
  • Physiological variables [ Time Frame: 0, 15, and 30 minutes ]

Enrollment: 16
Actual Study Start Date: January 17, 2009
Study Completion Date: April 7, 2009
Primary Completion Date: March 3, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00817297

Locations
Canada, Manitoba
GF-221 Health Sciences Centre
Winnipeg, Manitoba, Canada, R3E 0Z3
Sponsors and Collaborators
Respironics, California, Inc.
Investigators
Principal Investigator: Steven Mink, MD University of Manitoba, Winnipeg, Manitoba, Canada
  More Information

Responsible Party: Respironics, California, Inc.
ClinicalTrials.gov Identifier: NCT00817297     History of Changes
Other Study ID Numbers: V60-1050767VP v 2.4
Study First Received: January 3, 2009
Last Updated: April 17, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Respironics, California, Inc.:
noninvasive ventilation

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 25, 2017