Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 CO2 in arterial or venous blood)and 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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trilogy | Experimental | Trilogy Device |
|
| Standard of Care | Active Comparator | Participants prescribed ventilator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trilogy | Device | Exposure for one hour on the Trilogy ventilator |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Comparable Level of Gas Exchange (Measured as Partial Pressure of CO2 in Arterial or Venous Blood). | Blood gas was obtained for this study one hour after use of each device. | After one hour of ventilator use |
| Comparable Level of Gas Exchange SpO2 Levels During Various Modes of Ventilation. | Pulse Oximetry was measured after one hour of use of each ventilator. | After one hour of ventilator use |
| Measure | Description | Time Frame |
|---|---|---|
| Tidal Volume | Tidal volume is the amount of air that moves in or out of the lungs with each respiratory cycle. It measures around 500 mL in an average healthy adult male and approximately 400 mL in a healthy female. Average tidal volume was compare after a hour of use of each device. | One hour during ventilator use. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Clinically unstable, i.e.,
Patients suffering from metastatic or terminal cancer and patients with do-not-resuscitate orders
Pregnancy
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Steven Mink, MD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Manitoba | Winnipeg | Manitoba | R3E 0Z3 | Canada |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Trilogy First, Then Standard of Care | These participants used Trilogy first, then Standard of Care. |
| FG001 | Standard of Care First, Then Trilogy | these participants used Standard of Care first, then Trilogy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants Consented | All participants that were consented. |
| 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 CO2 in Arterial or Venous Blood). | Blood gas was obtained for this study one hour after use of each device. | Only 10 out of 11 total participants' data were used for blood gases due to one participant's venous line occluding. | Posted | Mean | Standard Deviation | mm Hg | After one hour of ventilator use |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Trilogy Device | Trilogy Device Trilogy: Exposure for one hour on the Trilogy ventilator |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeff Jasko | Philips | 412-542-3651 | jeff.jasko@philips.com |
Not provided
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard of Care |
| Device |
Exposure to participants current ventilator |
|
| Minute Ventilation |
Minute ventilation is the volume of gas inhaled or exhaled from a person's lungs per minute. This was measured after one hour of use of each device. |
| One hour during ventilator use. |
| Hemodynamics (Heart Rate) | Number of beats per minute. Measured after one hour of use of each device. | One hour during ventilator use. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Comparable Level of Gas Exchange SpO2 Levels During Various Modes of Ventilation. | Pulse Oximetry was measured after one hour of use of each ventilator. | Only 10 out of the 11 total participants' data were used for SpO2 due to missing data. Only 8 out of the 11 total participants data were used for SpO2 Standard of care analysis due to missing data. | Posted | Mean | Standard Deviation | mm Hg | After one hour of ventilator use |
|
|
|
| Secondary | Tidal Volume | Tidal volume is the amount of air that moves in or out of the lungs with each respiratory cycle. It measures around 500 mL in an average healthy adult male and approximately 400 mL in a healthy female. Average tidal volume was compare after a hour of use of each device. | Missing one data set for Standard of care. | Posted | Mean | Standard Deviation | mL/kg | One hour during ventilator use. |
|
|
|
| Secondary | Minute Ventilation | Minute ventilation is the volume of gas inhaled or exhaled from a person's lungs per minute. This was measured after one hour of use of each device. | Missing one data set for Standard of Care. | Posted | Mean | Standard Deviation | L/m | One hour during ventilator use. |
|
|
|
| Secondary | Hemodynamics (Heart Rate) | Number of beats per minute. Measured after one hour of use of each device. | Posted | Mean | Standard Deviation | beats per minute | One hour during ventilator use. |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Standard of Care | Participants prescribed ventilator Standard of Care: Exposure to participants current ventilator | 0 | 11 | 0 | 11 | 0 | 11 |
Not provided
Not provided