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Completed

NCT Number: NCT00817804

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

7 year–18 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

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Use of the V60 Mask Ventilator

Device

The V60 Mask Ventilator used to provide noninvasive ventilation. It is compared to the patient's conventional ventilator in a cross-over study. The ventilator settings can range from CPAP to Pressure Support ventilation with values of IPAP and EPAP to match the conventional ventilation on which the patient had been placed.

Other names: V60 is the Philips V60 Ventilator

Primary outcomes

  1. Breathing Comfort

    Time frame: 30 minutes

    Comfort on visual analog scale 0 - 100, 0 is best

Secondary outcomes

  1. Saturation of Arterial Oxygen

    Time frame: 30 minutes

  2. Respiratory Rate

    Time frame: 30 minutes

    Breathing rate in breaths per minute

  3. Minute Ventilation

    Time frame: 30 minutes

    Liters per minute that the patient breathes

  4. Heart Rate

    Time frame: 30 minutes

    Beats per minute that the patient's heart is beating

  5. Blood Pressure

    Time frame: 30 minutes

    Systolic and diastolic blood pressure

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 Pediatric 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
Aug 19, 2009

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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