Trial record 8 of 981 for:    ventilators

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

This study has been completed.
Sponsor:
Information provided by:
Respironics, California, Inc.
ClinicalTrials.gov Identifier:
NCT00817804
First received: January 3, 2009
Last updated: August 12, 2009
Last verified: August 2009
  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: 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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

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
Study First Received: January 3, 2009
Results First Received: May 5, 2009
Last Updated: August 12, 2009
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014