Trilogy Comparison Study - Pediatrics
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Philips Respironics
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Comparable Level of Gas Exchange for Peripheral Capillary Oxygen Saturation (SpO^2)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 1 Year to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age > 1years of age; < 18 years of age
- •Greater than 5 kg
- •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
- •Requiring mechanical ventilation through nasal/facial mask, tracheostomy or endotracheal tube (ET Tube)
Exclusion Criteria
- •Clinically unstable, i.e.,
- •Acute Respiratory Failure
- •Participants with refractory hypotension defined as systolic blood pressure less than 90 mm Hg despite inotropic agents)
- •Uncontrolled cardiac ischemia or arrhythmias
- •or as otherwise determined inappropriate for the study as determined by the investigator
- •Patients suffering from metastatic or terminal cancer and patients with do-not-resuscitate orders
Arms & Interventions
Trilogy ventilator
Trilogy ventilator
Intervention: Trilogy Ventilator (Device)
Standard of Care
Participants currently prescribed ventilator
Intervention: Standard of Care (Device)
Outcomes
Primary Outcomes
Comparable Level of Gas Exchange for Peripheral Capillary Oxygen Saturation (SpO^2)
Time Frame: After one hour of ventilator use
Comparable level of gas exchange for SpO\^2
Comparable Level of Gas Exchange (Measured as Partial Pressure of Carbon Dioxide (CO2) in Arterial, Venous or Capillary Blood)
Time Frame: After one hour of ventilator use
Comparable level of gas exchange (measured as partial pressure of CO2 in arterial, venous or capillary blood)
Secondary Outcomes
- Heart Rate(60 minutes)
- Minute Ventilation(60 minutes)
- Tidal Volume(60 minutes)