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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00817297
• Other study ID #: V60-1050767VP v 2.4
• Status: Completed
• Phase: N/A
• First received: January 3, 2009
• Last updated: November 13, 2017
• Start date: January 17, 2009
• Est. completion date: April 7, 2009

Study information

• Verified date: April 2017
• Source: Respironics, California, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 7, 2009
• Est. primary completion date: March 3, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• noninvasive 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

Locations

Country	Name	City	State
Canada	GF-221 Health Sciences Centre	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Respironics, California, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breathing comfort		0, 15, and 30 minutes
Secondary	Physiological variables		0, 15, and 30 minutes