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

Primary Purpose

Respiratory Insufficiency, Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Use of the V60 Mask Ventilator
Sponsored by
Respironics, California, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Insufficiency focused on measuring noninvasive ventilation

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GF-221 Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

V60 then Conventional

Conventional then V60

Arm Description

Study device first

Conventional device first

Outcomes

Primary Outcome Measures

Breathing Comfort
Comfort on visual analog scale 0 - 100, 0 is best

Secondary Outcome Measures

Saturation of Arterial Oxygen
Respiratory Rate
Breathing rate in breaths per minute
Minute Ventilation
Liters per minute that the patient breathes
Heart Rate
Beats per minute that the patient's heart is beating
Blood Pressure
Systolic and diastolic blood pressure

Full Information

First Posted
January 3, 2009
Last Updated
August 12, 2009
Sponsor
Respironics, California, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00817804
Brief Title
Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators
Official Title
Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators for Pediatric Patients With Respiratory Failure or Respiratory Insufficiency
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Respironics, California, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare a new noninvasive ventilator to existing ventilators already used for patient care.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency, Respiratory Failure
Keywords
noninvasive ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
V60 then Conventional
Arm Type
Experimental
Arm Description
Study device first
Arm Title
Conventional then V60
Arm Type
Experimental
Arm Description
Conventional device first
Intervention Type
Device
Intervention Name(s)
Use of the V60 Mask Ventilator
Other Intervention Name(s)
V60 is the Philips V60 Ventilator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Breathing Comfort
Description
Comfort on visual analog scale 0 - 100, 0 is best
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Saturation of Arterial Oxygen
Time Frame
30 minutes
Title
Respiratory Rate
Description
Breathing rate in breaths per minute
Time Frame
30 minutes
Title
Minute Ventilation
Description
Liters per minute that the patient breathes
Time Frame
30 minutes
Title
Heart Rate
Description
Beats per minute that the patient's heart is beating
Time Frame
30 minutes
Title
Blood Pressure
Description
Systolic and diastolic blood pressure
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Mink, MD
Organizational Affiliation
University of Manitoba, Winnipeg, Manitoba, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
GF-221 Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0Z3
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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