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

Not Applicable

Completed

• Conditions: Respiratory Insufficiency; Respiratory Failure
• Interventions: Device: Use of the V60 Mask Ventilator

• Registration Number: NCT00817804
• Lead Sponsor: Respironics, California, Inc.

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-03
• Study First Submitted QC: 2009-01-05
• Study First Posted: 2009-01-06
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Results First Submitted: 2009-05-05
• Results First Submitted QC: 2009-06-28
• Status Verified: 2009-08
• Results First Posted: 2009-08-12
• Last Update Submitted: 2009-08-12
• Last Update Posted: 2009-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Conventional then V60	Use of the V60 Mask Ventilator	Conventional device first
V60 then Conventional	Use of the V60 Mask Ventilator	Study device first

Primary Outcome Measures

Name	Time	Method
Breathing Comfort	30 minutes	Comfort on visual analog scale 0 - 100, 0 is best

Secondary Outcome Measures

Name	Time	Method
Saturation of Arterial Oxygen	30 minutes
Respiratory Rate	30 minutes	Breathing rate in breaths per minute
Minute Ventilation	30 minutes	Liters per minute that the patient breathes
Heart Rate	30 minutes	Beats per minute that the patient's heart is beating
Blood Pressure	30 minutes	Systolic and diastolic blood pressure

Trial Locations

Locations (1)

GF-221 Health Sciences Centre; 🇨🇦 Winnipeg, Manitoba, Canada