We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00817804
First Posted: January 6, 2009
Last Update Posted: August 19, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Respironics, California, Inc.
  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: Use of the V60 Mask Ventilator

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators for Pediatric 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: 30 minutes ]

Secondary Outcome Measures:
  • Saturation of Arterial Oxygen [ Time Frame: 30 minutes ]
  • Respiratory Rate [ Time Frame: 30 minutes ]
  • Minute Ventilation [ Time Frame: 30 minutes ]
  • Heart Rate [ Time Frame: 30 minutes ]
  • Blood Pressure [ Time Frame: 30 minutes ]

Enrollment: 3
Study Start Date: January 2009
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: V60 then Conventional
Study device first
Device: Use of the V60 Mask Ventilator
The V60 Mask Ventilator used to provide noninvasive ventilation. It is compared to the patient's conventional ventilator in a cross-over study. The ventilator settings can range from CPAP to Pressure Support ventilation with values of IPAP and EPAP to match the conventional ventilation on which the patient had been placed.
Other Name: V60 is the Philips V60 Ventilator
Experimental: Conventional then V60
Conventional device first
Device: Use of the V60 Mask Ventilator
The V60 Mask Ventilator used to provide noninvasive ventilation. It is compared to the patient's conventional ventilator in a cross-over study. The ventilator settings can range from CPAP to Pressure Support ventilation with values of IPAP and EPAP to match the conventional ventilation on which the patient had been placed.
Other Name: V60 is the Philips V60 Ventilator

Detailed Description:
This study compares the Respironics California V60 Mask ventilator to conventional noninvasive ventilators in a cross-over study with the patient as his/her own control.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 7 years and < 18 years
  • Weight > 20 kg (44 lbs)
  • Respiratory failure or respiratory insufficiency
  • Ability to cooperate with the investigators
  • Designated adult able to provide Informed Consent

Exclusion Criteria:

  • An endotracheal tube or tracheostomy in place
  • Hemodynamically 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
  • PaO2 < 50 mmHg on present settings
  • Designee unable or unwilling to provide Informed Consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00817804


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: Dr. Steven Mink, Professor of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada
ClinicalTrials.gov Identifier: NCT00817804     History of Changes
Other Study ID Numbers: V60-1050766VP v 2.3
First Submitted: January 3, 2009
First Posted: January 6, 2009
Results First Submitted: May 5, 2009
Results First Posted: August 12, 2009
Last Update Posted: August 19, 2009
Last Verified: August 2009

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


To Top