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 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).
Interventions
DEVICETrilogy Ventilator
Exposure to one hour on the Trilog ventilator
DEVICEStandard of Care
Exposure of one hour on the Participants prescribed ventilator
Sponsors
Philips Respironics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Age \> 1years of age; \< 18 years of age 2. Greater than 5 kg 3. 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 4. 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 Carbon Dioxide (CO2) in Arterial, Venous or Capillary Blood) | After one hour of ventilator use | Comparable level of gas exchange (measured as partial pressure of CO2 in arterial, venous or capillary blood) |
| Comparable Level of Gas Exchange for Peripheral Capillary Oxygen Saturation (SpO^2) | After one hour of ventilator use | Comparable level of gas exchange for SpO\^2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | 60 minutes | heart rate as measured by beats per minute |
| Minute Ventilation | 60 minutes | Minute ventilation |
| Tidal Volume | 60 minutes | Tidal Volume |
Countries
Canada
Participant flow
Recruitment details
One participant was reconsented to complete the assessment on new software, this participants was not counted twice in the demographics or protocol enrollment.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Consented All participants consented for the study. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | All Participants Consented |
|---|---|
| Age, Continuous | 7.2 years STANDARD_DEVIATION 6.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment Canada | 6 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Comparable Level of Gas Exchange for Peripheral Capillary Oxygen Saturation (SpO^2)
Comparable level of gas exchange for SpO\^2
Time frame: After one hour of ventilator use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trilogy Ventilator | Comparable Level of Gas Exchange for Peripheral Capillary Oxygen Saturation (SpO^2) | 94.6 mmHg | Standard Deviation 4 |
| Standard of Care | Comparable Level of Gas Exchange for Peripheral Capillary Oxygen Saturation (SpO^2) | 97.0 mmHg | Standard Deviation 1.9 |
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)
Time frame: After one hour of ventilator use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trilogy Ventilator | Comparable Level of Gas Exchange (Measured as Partial Pressure of Carbon Dioxide (CO2) in Arterial, Venous or Capillary Blood) | 37 mEq/L | Standard Deviation 7.5 |
| Standard of Care | Comparable Level of Gas Exchange (Measured as Partial Pressure of Carbon Dioxide (CO2) in Arterial, Venous or Capillary Blood) | 33.3 mEq/L | Standard Deviation 11.9 |
Secondary
Heart Rate
heart rate as measured by beats per minute
Time frame: 60 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trilogy Ventilator | Heart Rate | 114.5 bpm | Standard Deviation 26.4 |
| Standard of Care | Heart Rate | 103.8 bpm | Standard Deviation 18.1 |
Secondary
Minute Ventilation
Minute ventilation
Time frame: 60 minutes
Population: One data point not captured
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trilogy Ventilator | Minute Ventilation | 4.9 Lpm | Standard Deviation 2.25 |
| Standard of Care | Minute Ventilation | 5.3 Lpm | Standard Deviation 3.2 |
Secondary
Tidal Volume
Tidal Volume
Time frame: 60 minutes
Population: One data point not captured for a participant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trilogy Ventilator | Tidal Volume | 239 mL/kg | Standard Deviation 221 |
| Standard of Care | Tidal Volume | 226 mL/kg | Standard Deviation 209 |