RARICO is a pragmatic, randomized, controlled, double-blinded, multi-center trial evaluating the safety and feasibility of nebulized revefenacin in comparison to nebulized ipratropium in patients with COPD and acute respiratory failure requiring invasive mechanical ventilation.
Objective: To assess the efficacy of nebulized revefenacin in improving the lung mechanics of COPD patients with acute respiratory failure requiring invasive mechanical ventilation (MV), in comparison to a control group receiving the short-acting muscarinic antagonist ipratropium. Hypothesis: Revefenacin is as efficacious as ipratropium in improving the lung mechanics of COPD patients with acute respiratory failure. Study Design: RARICO is a pragmatic, randomized, controlled, double-blinded, multi-center trial evaluating the safety and feasibility of nebulized revefenacin in comparison to nebulized ipratropium in patients with COPD and acute respiratory failure requiring invasive mechanical ventilation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
21
nebulized drug comparison
nebulized drug comparison
Ronald Reagan Medical Center at UCLA
Los Angeles, California, United States
Santa Monica UCLA
Santa Monica, California, United States
Reduction in total inspiratory resistance Rstat at the time of drug trough
Reduction in total inspiratory resistance across the airways and ventilator circuit measured by the change in Static Resistance (Rstat) at the time of drug trough
Time frame: 7 days
Reduction in total inspiratory resistance Rdyn at the time of drug trough
Reduction in total inspiratory resistance across the airways and ventilator circuit measured by the change in Dynamic Resistance (Rdyn) at the time of drug trough
Time frame: 7 days
Reduction in Resistive pressure (Pres) at the time of drug trough
Reduction in total inspiratory resistance across the airways and ventilator circuit measured by the change in Resistive pressure (Pres) at the time of drug trough
Time frame: 7 days
Reduction in total inspiratory resistance Rstat at the time of drug peak
Reduction in total inspiratory resistance across the airways and ventilator circuit measured by the change in Static Resistance (Rstat) at the time of drug peak
Time frame: 7 days
PaCO2
Arterial partial pressure of CO2 measured at the drug trough
Time frame: 7 days
Respiratory therapist time at bedside
RT resource utilization as reflected in the total effective time spent at the bedside providing care
Time frame: 7 days
ICU Length of stay
Time spent in the ICU from the enrollment in the study through the same-stay discharge from the hospital
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Time frame: Hospital stay, expected to be less than 28 days
Ventilator-free days to day 28
Time spent ventilator-free from the day of enrollment in the study through the same-stay discharge from the hospital
Time frame: Hospital stay, expected to be less than 28 days