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The purpose of this study is to compare a new noninvasive ventilator to existing ventilators already used for patient care.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V60 then Conventional | Experimental | Study device first |
|
| Conventional then V60 | Experimental | Conventional device first |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Breathing Comfort | Comfort on visual analog scale 0 - 100, 0 is best | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Saturation of Arterial Oxygen | 30 minutes | |
| Respiratory Rate | Breathing rate in breaths per minute | 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Mink, MD | University of Manitoba, Winnipeg, Manitoba, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GF-221 Health Sciences Centre | Winnipeg | Manitoba | R3E 0Z3 | Canada |
Excluded if did not meet inclusion or did meet exclusion criteria.
Hospitalized adult patients enrolled between Jan 17 and Mar 3, 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | V60 First | Experimental Study device (used as the experimental device) first in the cross-over study |
| FG001 | Conventional First | Experimental Study device (used as the experimental device) second in the cross-over study |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | V60 First | Experimental Study device (used as the experimental device) first in the cross-over study |
| BG001 | Conventional First | Experimental Study device (used as the experimental device) second in the cross-over study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Breathing Comfort | Comfort on visual analog scale 0 - 100, 0 is best | Analysis was per protocol | Posted | Mean | Standard Error | visual analog scale | 30 minutes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | V60 First | Experimental Study device (used as the experimental device) first in the cross-over study |
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Terminated before 20 patients enrolled
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Seiver | Respironics California | 760-703-6993 | adam.seiver@philips.com |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
|
| Minute Ventilation |
Liters per minute that the patient breathes |
| 30 minutes |
| Heart Rate | Beats per minute that the patient's heart is beating | 30 minutes |
| Blood Pressure | Systolic and diastolic blood pressure | 30 minutes |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
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| Secondary | Saturation of Arterial Oxygen | Not Posted | Dec 2011 | Number | Percent | 30 minutes |
| Secondary | Respiratory Rate | Breathing rate in breaths per minute | Not Posted | Dec 2011 | Number | Breaths per minute | 30 minutes |
| Secondary | Minute Ventilation | Liters per minute that the patient breathes | Not Posted | Number | liters per minute | 30 minutes |
| Secondary | Heart Rate | Beats per minute that the patient's heart is beating | Not Posted | Number | Beats per minute | 30 minutes |
| Secondary | Blood Pressure | Systolic and diastolic blood pressure | Not Posted | Number | mm Hg | 30 minutes |
| 0 |
| 0 |
| EG001 | Conventional First | Experimental Study device (used as the experimental device) second in the cross-over study | 0 | 0 |
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