N/A Completed N=11 Randomized Single-blind Treatment

Trilogy Comparison Study - Adults

Respiratory Insufficiency · Respiratory Failure

Source: ClinicalTrials.gov NCT00810498 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2021

Primary outcomePrimary: Comparable Level of Gas Exchange (Measured as Partial Pressure of CO2 in Arterial or Venous Blood). — 42; 43 mm Hg

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 CO2 in Arterial or Venous Blood).	42; 43	—
PRIMARY Comparable Level of Gas Exchange SpO2 Levels During Various Modes of Ventilation.	98; 97	—
SECONDARY Tidal Volume	479; 498	—
SECONDARY Minute Ventilation	10.11; 10.11	—
SECONDARY Hemodynamics (Heart Rate)	89.9; 90.4	—

Eligibility Criteria

Inclusion Criteria

Age > 21 years of age; < 85 years of age
Able to follow instructions
Able to provide informed consent
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00810498). 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.