Short summary

A prospective randomized controlled clinical open-label trial will be performed to determine the best supplementary oxygen treatment option for Chronic Obstructive Pulmonary Disease patients with acute exacerbation. In this study we compare two different peripheral oxygen saturation levels - 88-92% vs. >94%, to the outcome of 30-day all-cause mortality. 

Rationale

COPD is believed to be the fourth leading cause of death globally (Lozano et al., 2012). Patients with severe exacerbation of COPD require hospitalization. Current oxygen treatment recommendations are based on one single study from prehospital sector in Australia in which they found a lower mortality for patients treated with titrated oxygen compared with patients treated with free flow oxygen (9% vs. 4%, p=0.02) (Austin et al., 2010). It should be noted that 37% of all patients for this study were not treated according to protocol. Since then, a small retrospective Danish study surprisingly found, that patients on oxygen therapy with a peripheral oxygen saturation >92% had a lower mortality than patients with a lower saturation (5% vs. 16%) (Ringbæk et al., 2015). 

We have not been able to identify any studies (published or planned) that seek to clarify the best supplementary oxygen treatment option for COPD patients with acute exacerbation in an emergency department or acute medical unit. But as almost all COPD patients will pass through these departments and assessment and treatment will be initiated here, there is a dire need for additional clarity. We therefore propose this study to identify the best treatment modality of supplementary oxygen for COPD patients arriving with acute exacerbation. 

AUSTIN, M. A., WILLS, K. E., BLIZZARD, L., WALTERS, E. H. & WOOD-BAKER, R. 2010. Effect of high flow oxygen on mortality in chronic obstructive pulmonary disease patients in prehospital setting: Randomised controlled trial. Bmj, 341, c5462.

LOZANO, R., NAGHAVI, M., FOREMAN, K., LIM, S., SHIBUYA, K., ABOYANS, V., ABRAHAM, J., ADAIR, T., AGGARWAL, R. & AHN, S. Y. 2012. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. The lancet, 380, 2095-2128.

RINGBÆK, T. J., TERKELSEN, J. & LANGE, P. 2015. Outcomes of acute exacerbations in COPD in relation to pre-hospital oxygen therapy. European clinical respiratory journal, 2.

Description of the cohort

A randomized clinical trial of adult patients with acute exacerbation of Chronic Obstructive Pulmonary Disease. 

Data and biological material

Data collected bedside, from the medical records and extracted from the hospital computer (blood test results). 

Collaborating researchers and departments

Emergency Department, Holbæk Hospital

• Peter Hallas, MD

Emergency Department, Odense University Hospital

• Sune Laugesen, MD

Emergency Department, Kolding Hospital

• Simon Thorgaard-Rasmussen, MD

Department of Clinical Biochemistry, Hospital of South West Jutland