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 Pediatric Patients With Respiratory Failure or Respiratory Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00817804
• Other study ID #: V60-1050766VP v 2.3
• Status: Completed
• Phase: N/A
• First received: January 3, 2009
• Last updated: August 12, 2009
• Start date: January 2009
• Est. completion date: March 2009

Study information

• Verified date: August 2009
• Source: Respironics, California, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• 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:

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.

Recruitment information / eligibility

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

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Use of the V60 Mask Ventilator
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.

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		30 minutes	Yes
Secondary	Saturation of Arterial Oxygen		30 minutes	Yes
Secondary	Respiratory Rate		30 minutes	Yes
Secondary	Minute Ventilation		30 minutes	Yes
Secondary	Heart Rate		30 minutes	Yes
Secondary	Blood Pressure		30 minutes	Yes