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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

noninvasive ventilator

About this trial

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

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age > 18 years and < 85 years
Weight > 20 kg (44 lbs)
Respiratory failure or respiratory insufficiency
Ability to cooperate with the investigators

Exclusion Criteria:

An endotracheal tube or tracheostomy in place
Hemodynamic 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
Inability or unwillingness to provide Informed Consent
PaO2 < 50 mmHg

Sites / Locations

GF-221 Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

V60 Mask, Then Conventional Mask

Conventional Mask, Then V60 Mask

Arm Description

Experimental V60 Mask Ventilator for treating adult patients with COPD, then Comparator Conventional Mask Ventilator for treating adult patients with COPD

Comparator Conventional Mask noninvasive Ventilator for treating adult patients with COPD, then Experimental V60 Mask noninvasive Ventilator for treating adult patients with COPD.

Outcomes

Primary Outcome Measures

Breathing comfort

Secondary Outcome Measures

Physiological variables

Full Information

NCT ID

NCT00817297

First Posted

January 3, 2009

Last Updated

November 13, 2017

Sponsor

Respironics, California, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00817297

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 Adult Patients With Respiratory Failure or Respiratory Insufficiency

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

January 17, 2009 (Actual)

Primary Completion Date

March 3, 2009 (Actual)

Study Completion Date

April 7, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Respironics, California, Inc.

4. Oversight

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

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

The primary objective of this study was to compare the performance (i.e., patient self-reported Comfort score) of the V60 device and a conventional noninvasive ventilator (patient's current ventilator). For the User Needs Assessment, the primary objective of the study was to validate the V60 to user needs. All patients were volunteers from the Respiratory Section of the Health Sciences Centre at the University of Manitoba. The study utilized a randomized 2-period cross-over study design to compare the V60 System to the patients' existing conventional noninvasive ventilator in different ventilation modes.

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

Participant

Masking Description

Subject was blinded to device identity

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

V60 Mask, Then Conventional Mask

Arm Type

Other

Arm Description

Experimental V60 Mask Ventilator for treating adult patients with COPD, then Comparator Conventional Mask Ventilator for treating adult patients with COPD

Arm Title

Conventional Mask, Then V60 Mask

Arm Type

Other

Arm Description

Comparator Conventional Mask noninvasive Ventilator for treating adult patients with COPD, then Experimental V60 Mask noninvasive Ventilator for treating adult patients with COPD.

Intervention Type

Device

Intervention Name(s)

noninvasive ventilator

Intervention Description

Experimental V60 Mask noninvasive Ventilator for treating patients with COPD, then Comparator Conventional Mask noninvasive Ventilator for treating patients with COPD in crossover study design

Primary Outcome Measure Information:

Title

Breathing comfort

Time Frame

0, 15, and 30 minutes

Secondary Outcome Measure Information:

Title

Physiological variables

Time Frame

0, 15, and 30 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age > 18 years and < 85 years Weight > 20 kg (44 lbs) Respiratory failure or respiratory insufficiency Ability to cooperate with the investigators Exclusion Criteria: An endotracheal tube or tracheostomy in place Hemodynamic 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 Inability or unwillingness to provide Informed Consent PaO2 < 50 mmHg

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

Plan to Share IPD

Learn more about this trial

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

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