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

Respironics

Status: Completed

Conditions: Respiratory Failure; Respiratory Insufficiency

Treatments: Device: noninvasive ventilator

Study type: Interventional

Funder types: Industry

Identifiers

NCT00817297

V60-1050767VP v 2.4

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

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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16 participants in 2 patient groups

V60 Mask, Then Conventional Mask

Other group

Description:

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

Treatment:

Device: noninvasive ventilator

Conventional Mask, Then V60 Mask

Other group

Description:

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

Treatment:

Device: noninvasive ventilator