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Non-invAsive VentIlation for early General wArd respiraTory failurE (NAVIGATE): A multicenter randomized controlled
Luca Cabrini1, Claudia Brusasco2, Agostino Roasio3
1Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Contemporary Clinical Trials
|February 11, 2019
Summary
Early non-invasive ventilation (NIV) for acute respiratory failure (ARF) in general hospital wards may prevent severe ARF. This study investigates NIV
Area of Science:
- Critical Care Medicine
- Respiratory Medicine
- Clinical Trials
Background:
- Randomized trials on non-invasive ventilation (NIV) for early acute respiratory failure (ARF) in non-intensive care units (ICUs) are limited.
- Early intervention for mild-moderate ARF in general wards is crucial to prevent progression to severe respiratory failure.
Purpose of the Study:
- To evaluate the efficacy of early NIV in preventing severe ARF in patients on non-ICU wards.
- To test the hypothesis that NIV can avert the progression of mild-moderate ARF to severe ARF outside the ICU setting.
Main Methods:
- A pragmatic, parallel-group, randomized, controlled, multicenter trial.
- 520 patients with mild-moderate ARF on non-ICU wards were randomized to receive NIV plus best care or best care alone.
- Primary endpoint: development of severe ARF. Secondary endpoints: mortality, hospital stay, safety, and respiratory complications.
Main Results:
- The study is designed to enroll 520 patients, with 260 in each arm.
- Primary outcome is the prevention of severe ARF.
- Secondary outcomes include 28-day mortality, hospital length of stay, and safety of NIV in non-ICU settings.
Conclusions:
- This trial aims to determine if early NIV in non-ICU wards can prevent the progression of mild-moderate ARF to severe ARF.
- Findings will inform clinical practice regarding NIV use in general hospital settings for respiratory failure.
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