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Completed

NCT Number: NCT00817297

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

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

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Key information

Conditions

Respiratory Insufficiency Respiration Disorders Respiratory Failure Respiratory Tract Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GF-221 Health Sciences Centre

Winnipeg, Manitoba, R3E 0Z3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

noninvasive ventilator

Device

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

Primary outcomes

  1. Breathing comfort

    Time frame: 0, 15, and 30 minutes

Secondary outcomes

  1. Physiological variables

    Time frame: 0, 15, and 30 minutes

Sponsors and collaborators

Lead sponsor

Respironics, California, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 6, 2009
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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