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

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:

MedlinePlus related topics: Respiratory Failure

U.S. FDA Resources

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

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

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 May 21, 2013