Respiratory Insufficiency, Respiratory Failure
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DEVICETrilogy
Exposure for one hour on the Trilogy ventilator
DEVICEStandard of Care
Exposure to participants current ventilator
Sponsors
Philips Respironics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age \> 21 years of age; \< 85 years of age 2. Able to follow instructions 3. Able to provide informed consent 4. Considered clinically stable, with low flow oxygen requirements less than 15 LPM (or FIO2 less than 60 %) and PEEP no greater than 10 cm H2O. 5. Requiring mechanical ventilation through nasal/facial mask,tracheostomy or endotracheal tube (ET Tube)
Exclusion criteria
1. Clinically unstable, i.e., 1. Acute Respiratory Failure 2. Participants with refractory hypotension defined as systolic blood pressure less than 90 mm Hg despite inotropic agents), 3. Uncontrolled cardiac ischemia or arrhythmias, 4. or as otherwise determined inappropriate for the study as determined by the investigator. 2. Patients suffering from metastatic or terminal cancer and patients with do-not-resuscitate orders 3. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparable Level of Gas Exchange (Measured as Partial Pressure of CO2 in Arterial or Venous Blood). | After one hour of ventilator use | Blood gas was obtained for this study one hour after use of each device. |
| Comparable Level of Gas Exchange SpO2 Levels During Various Modes of Ventilation. | After one hour of ventilator use | Pulse Oximetry was measured after one hour of use of each ventilator. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tidal Volume | One hour during ventilator use. | 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. |
| Minute Ventilation | One hour during ventilator use. | 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. |
| Hemodynamics (Heart Rate) | One hour during ventilator use. | Number of beats per minute. Measured after one hour of use of each device. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Consented All participants that were consented. | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | All Participants Consented |
|---|---|
| Age, Continuous | 57.8 years STANDARD_DEVIATION 8.82 |
| Region of Enrollment Canada | 11 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
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.
Time frame: After one hour of ventilator use
Population: Only 10 out of 11 total participants' data were used for blood gases due to one participant's venous line occluding.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trilogy | Comparable Level of Gas Exchange (Measured as Partial Pressure of CO2 in Arterial or Venous Blood). | 42 mm Hg | Standard Deviation 14 |
| Standard of Care | Comparable Level of Gas Exchange (Measured as Partial Pressure of CO2 in Arterial or Venous Blood). | 43 mm Hg | Standard Deviation 14 |
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.
Time frame: After one hour of ventilator use
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trilogy | Comparable Level of Gas Exchange SpO2 Levels During Various Modes of Ventilation. | 98 mm Hg | Standard Deviation 2 |
| Standard of Care | Comparable Level of Gas Exchange SpO2 Levels During Various Modes of Ventilation. | 97 mm Hg | Standard Deviation 2 |
Secondary
Hemodynamics (Heart Rate)
Number of beats per minute. Measured after one hour of use of each device.
Time frame: One hour during ventilator use.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trilogy | Hemodynamics (Heart Rate) | 89.9 beats per minute | Standard Deviation 19 |
| Standard of Care | Hemodynamics (Heart Rate) | 90.4 beats per minute | Standard Deviation 19.7 |
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.
Time frame: One hour during ventilator use.
Population: Missing one data set for Standard of Care.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trilogy | Minute Ventilation | 10.11 L/m | Standard Deviation 1.94 |
| Standard of Care | Minute Ventilation | 10.11 L/m | Standard Deviation 2.12 |
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.
Time frame: One hour during ventilator use.
Population: Missing one data set for Standard of care.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trilogy | Tidal Volume | 479 mL/kg | Standard Deviation 182 |
| Standard of Care | Tidal Volume | 498 mL/kg | Standard Deviation 128 |