Efficacy of Helium/Oxygen Compared to Air/Oxygen in Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

Summary

The primary objective of the study is to evaluate the efficacy of Helium/Oxygen (He/O2) 78%/22% compared to a conventional Air/O2 mixture in reducing endotracheal intubation rate and mortality in patients with severe hypercapnic exacerbations of Chronic Obstructive Pulmonary Disease (COPD) during their index Intensive/Intermediate Care Unit (ICU) stay.

Timeline

Start

2010-05

Primary completion

2013-10

Completion

2014-06

Outcome

Missed primary endpoint

Stopped: “the observed event rate is lower than expected by the protocol hypothesis.”

paper NIV failure: air/O2 14.5% [n = 32]; heliox 14.7% [n = 33]; P = 0.97 PMID 27736154 ↗

paper Heliox improves respiratory acidosis, encephalopathy, and the respiratory rate more quickly than air/O2 but does not prevent NIV failure. PMID 27736154 ↗

Publications

• 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. A Multicenter Randomized Trial Assessing the Efficacy of Helium/Oxygen in Severe Exacerbations of Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2017 Apr 1;195(7):871-880. doi: 10.1164/rccm.201601-0083OC.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Helium/Oxygen	Unknown	—	Inhaled
Comparator	Oxygen	Other / unclassified	—	Inhaled

Indications