N/A
Completed N=6
Trilogy Comparison Study - Pediatrics
Source: ClinicalTrials.gov NCT00810459 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Comparable Level of Gas Exchange (Measured as Partial Pressure of Carbon Dioxide (CO2) in Arterial, Venous or Capillary Blood) — 37; 33.3 mEq/L
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparable Level of Gas Exchange (Measured as Partial Pressure of Carbon Dioxide (CO2) in Arterial, Venous or Capillary Blood) |
37; 33.3 | — |
| PRIMARY Comparable Level of Gas Exchange for Peripheral Capillary Oxygen Saturation (SpO^2) |
94.6; 97.0 | — |
| SECONDARY Heart Rate |
114.5; 103.8 | — |
| SECONDARY Minute Ventilation |
4.9; 5.3 | — |
| SECONDARY Tidal Volume |
239; 226 | — |
Eligibility Criteria
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
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT00810459). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.