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The objective of this study (Part II) will be to compare the performance of the Trilogy device and a conventional ventilator (participant's current device). Both devices will be set to the participants' current mode and prescription settings.
A. Primary Hypothesis and end-point In patients with respiratory insufficiency, when compared to conventional ventilators, the Trilogy device achieves comparable level of gas exchange (measured as partial pressure of carbon dioxide (CO2) in arterial, venous or capillary blood)and peripheral capillary oxygen saturation, (SpO2) levels during various modes of ventilation.
B. Secondary Hypothesis and end-points In patients with respiratory insufficiency, when compared to conventional ventilators, the Trilogy device achieves comparable breathing pattern (tidal volume, respiratory rate, minute ventilation), hemodynamics (heart rate), and subjective measures of breathing comfort (measured by modified Borg dyspnea scale).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trilogy ventilator | Experimental | Trilogy ventilator |
|
| Standard of Care | Active Comparator | Participants currently prescribed ventilator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trilogy Ventilator | Device | Exposure to one hour on the Trilog ventilator |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Comparable Level of Gas Exchange (Measured as Partial Pressure of Carbon Dioxide (CO2) in Arterial, Venous or Capillary Blood) | Comparable level of gas exchange (measured as partial pressure of CO2 in arterial, venous or capillary blood) | After one hour of ventilator use |
| Comparable Level of Gas Exchange for Peripheral Capillary Oxygen Saturation (SpO^2) | Comparable level of gas exchange for SpO^2 | After one hour of ventilator use |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | heart rate as measured by beats per minute | 60 minutes |
| Minute Ventilation | Minute ventilation | 60 minutes |
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Inclusion Criteria:
Exclusion Criteria:
Clinically unstable, i.e.,
Patients suffering from metastatic or terminal cancer and patients with do-not-resuscitate orders
Pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Steven Mink, MD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Manitoba | Winnipeg | Manitoba | Canada |
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One participant was reconsented to complete the assessment on new software, this participants was not counted twice in the demographics or protocol enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Trilogy Ventilator First, Then Standard of Care Ventilator | These participants used the Trilogy Ventilator first, then Standard of Care Ventilator |
| FG001 | Standard of Care Ventilator First, Then Trilogy Ventilator | Theses participants used the Standard of Care Ventilator first and then Trilogy Ventilator. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants Consented | All participants consented for the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Comparable Level of Gas Exchange (Measured as Partial Pressure of Carbon Dioxide (CO2) in Arterial, Venous or Capillary Blood) | Comparable level of gas exchange (measured as partial pressure of CO2 in arterial, venous or capillary blood) | Posted | Mean | Standard Deviation | mEq/L | After one hour of ventilator use |
|
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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 | Trilogy Ventilator | Trilogy ventilator Trilogy Ventilator: Exposure to one hour on the Trilogy ventilator |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeff Jasko | Philips | 412-542-3651 | Jeff.Jasko@philips.com |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Standard of Care |
| Device |
Exposure of one hour on the Participants prescribed ventilator |
|
| Tidal Volume | Tidal Volume | 60 minutes |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Comparable Level of Gas Exchange for Peripheral Capillary Oxygen Saturation (SpO^2) | Comparable level of gas exchange for SpO^2 | Posted | Mean | Standard Deviation | mmHg | After one hour of ventilator use |
|
|
|
| Secondary | Heart Rate | heart rate as measured by beats per minute | Posted | Mean | Standard Deviation | bpm | 60 minutes |
|
|
|
| Secondary | Minute Ventilation | Minute ventilation | One data point not captured | Posted | Mean | Standard Deviation | Lpm | 60 minutes |
|
|
|
| Secondary | Tidal Volume | Tidal Volume | One data point not captured for a participant | Posted | Mean | Standard Deviation | mL/kg | 60 minutes |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Standard of Care Ventilator | Participants currently prescribed ventilator Standard of Care: Exposure of one hour on the Participants prescribed ventilator | 0 | 6 | 0 | 6 | 0 | 6 |
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