An international phase iii randomised trial on the efficacy of helium/oxygen during spontaneous breathing and intermittent non-invasive ventilation for severe exacerbations of chronic obstructive pulmonary disease (the E.C.H.O.ICUtrial)
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KeywordsChronic Obstructive Pulmonary Disease Spontaneous Breathing Intubation Rate Rehospitalization Rate Grant Acknowledgment
Due to its reduced density, Helium/Oxygen (He/O2) reduces the work of breathing, intrinsic PEEP and hypercapnia more than Air/O2 during non-invasive ventilation (NIV) in COPD exacerbations [1, 2]. Two prospective, randomized multicenter trials were inconclusive in showing a benefit of He/O2 NIV on outcome (intubation, mortality, length of stay (LOS) in ICU) but were potentially underpowered [3, 4].
To evaluate whether 72-hr continuous He/O2 during both spontaneous breathing and NIV is superior to Air/O2 in reducing NIV failure (intubation or mortality during ICU stay) in severe hypercapnic COPD exacerbations. Secondary outcomes included physiological parameters, duration of ventilation, ICU and hospital LOS, 6-month recurrence and rehospitalization rates.
Prospective, randomized multicenter (16 centers in 6 countries) trial, comparing the two gas mixtures for a maximum of 72 hours. Hypothesis was that He/O2 would reduce intubation rate from 25% to 15%, resulting in a total sample size of 670 patients. Spontaneous breathing and NIV were applied with specific devices for He/O2. Same ventilator was used in both arms.
NIV failure rate was not reduced by He/O2 administered during NIV and spontaneous breathing for up to 72 hrs. Failure rate was low in both groups, reflecting the current efficacy of NIV in decompensated COPD. However, He/O2 led to improved physiological response, thus confirming previous results, and a shorter duration of invasive ventilation and ICU stay in patients with NIV failure.
ClinicalTrials.gov Identifier: NCT01155310. Study funded by Air Liquide Healthcare.
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