A Multicenter Randomized Trial Assessing the Efficacy of Helium/Oxygen in Severe Exacerbations of Chronic Obstructive Pulmonary Disease.

Am J Respir Crit Care Med. 2016 Oct 13;

Authors: Jolliet P, Ouanes-Besbes L, Abroug F, Ben Khelil J, Besbes M, Garnero A, Arnal JM, Daviaud F, Chiche JD, Lortat-Jacob B, Diehl JL, Lerolle N, Mercat A, Razazi K, Brun-Buisson C, Durand-Zaleski I, Texereau J, Brochard L, E.C.H.O.^ICU trial investigators

Abstract
RATIONALE: During non-invasive ventilation (NIV) for COPD exacerbations, Helium/Oxygen (He/O2) reduces work of breathing and hypercapnia more than Air/O2 but impact on clinical outcome remains unknown.
OBJECTIVE: To determine whether continuous administration of He/O2 for 72 hours, during and in-between NIV sessions, is superior to Air/O2 in reducing NIV failure (25% to 15%) in severe hypercapnic COPD exacerbations.
METHODS: Prospective, randomized, open-label trial (16 intensive care units, 6 countries).
INCLUSION CRITERIA: COPD exacerbations with PaCO2 ≥ 45 mmHg, pH ≤ 7.35, and at least one: respiratory rate ≥ 25/min, PaO2 ≤ 50 mmHg, SpO2 ≤ 90%. A 6-month follow-up was performed.
OUTCOMES: Main: NIV failure (intubation or death without intubation in ICU). Secondaries: physiological parameters, duration of ventilation, ICU and hospital stay, 6-month recurrence and rehospitalization rates.
MAIN RESULTS: Trial stopped prematurely (445 randomized patients) for a low global failure rate. NIV failure: Air/O2 14.5% (N=32), He/O2 14.7% (N=33, p=0.97). Time to NIV failure: He/O2 group 93 hours (N=33), Air/O2 group 52 hours (N=32, p=0.12). Respiratory rate, pH, PaCO2 and encephalopathy score improved significantly faster with He/O2. ICU stay was comparable between groups. In patients intubated after failing NIV, He/O2 patients had a shorter ventilation duration (7.4±7.6 vs 13.6±12.6 d, p = 0.02) and ICU stay (15.8±10.9 vs 26.7±21.0 days, p = 0.01). No difference was observed in ICU and 6-month mortality.
CONCLUSIONS: He/O2 improves respiratory acidosis, encephalopathy and respiratory rate more quickly than Air/O2 but does not prevent NIV failure. Overall, the rate of NIV failure is low. Clinical trial registration available at www.clinicaltrials.gov, ID NCT01155310.

PMID: 27736154 [PubMed - as supplied by publisher]