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 Pediatric 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: Use of the V60 Mask 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.

• Study Type: Interventional
• Enrollment (Actual): 3
• 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: 7 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: V60 is the Philips V60 Ventilator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breathing Comfort	Comfort on visual analog scale 0 - 100, 0 is best	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Saturation of Arterial Oxygen		30 minutes
Respiratory Rate	Breathing rate in breaths per minute	30 minutes
Minute Ventilation	Liters per minute that the patient breathes	30 minutes
Heart Rate	Beats per minute that the patient's heart is beating	30 minutes
Blood Pressure	Systolic and diastolic blood pressure	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: January 1, 2009
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 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 (Estimate): August 19, 2009
• Last Update Submitted That Met QC Criteria: August 12, 2009
• Last Verified: August 1, 2009

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: V60-1050766VP v 2.3