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

Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators for Adult Patients With Respiratory Failure or Respiratory Insufficiency

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00817297

Enrollment

Registered

2009-01-06

Start date

2009-01-17

Completion date

2009-04-07

Last updated

2017-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure, Respiratory Insufficiency

Keywords

noninvasive ventilation

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.

Interventions

DEVICEnoninvasive ventilator

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

Subject was blinded to device identity

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
Breathing comfort	0, 15, and 30 minutes

Secondary

Measure	Time frame
Physiological variables	0, 15, and 30 minutes

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026