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

NCT ID: NCT00817804

Last Updated: 2009-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-03-31

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.

Conditions

Respiratory Insufficiency; Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

V60 then Conventional

Study device first

Group Type: EXPERIMENTAL

Use of the V60 Mask Ventilator

Intervention Type: DEVICE

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.

Conventional then V60

Conventional device first

Group Type: EXPERIMENTAL

Use of the V60 Mask Ventilator

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

V60 is the Philips V60 Ventilator

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Respironics, California, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Professor of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada

Principal Investigators

Steven Mink, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba, Winnipeg, Manitoba, Canada

Locations

GF-221 Health Sciences Centre

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

V60-1050766VP v 2.3

Identifier Type: -

Identifier Source: org_study_id