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

Respironics

Status: Completed

Conditions: Respiratory Failure; Respiratory Insufficiency

Treatments: Device: Use of the V60 Mask Ventilator

Study type: Interventional

Funder types: Industry

Identifiers

NCT00817804

V60-1050766VP v 2.3

Details and patient eligibility

About

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

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 7 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

V60 then Conventional

Experimental group

Description:

Study device first

Treatment:

Device: Use of the V60 Mask Ventilator

Conventional then V60

Experimental group

Description:

Conventional device first

Treatment:

Device: Use of the V60 Mask Ventilator