Comparing Mortality for Low vs High Peripheral Oxygen Saturation in COPD-patients With Acute Exacerbation
Status:
Recruiting
Trial end date:
2022-08-31
Target enrollment:
Participant gender:
Summary
Chronic obstructive pulmonary disease (COPD) is a common disorder that affects approximately
400,000 Danish citizens. About 3,000-3,500 Danes die yearly because of the disorder, and the
costs associated with hospital admissions are estimated to be 535 million Danish kroner
(DKK). Patients with COPD risk a worsening of their disorder, and in most cases, this will
require hospitalization. One of the used treatments is providing oxygen to the patients via
e.g. masks. The recommendations on oxygen treatment are currently based on a study from 2010
where 37% of the participants in this study did not receive the intended treatment, which may
have had massive effects on the results. It is worrying that no other studies have shown
which oxygen treatment is safest for the patients. As such, we deem it important to study how
best to treat the patients.
Our study is of high clinical relevance as hospitals receive patients with worsening of COPD
daily. We need more, better data regarding the oxygen treatment of our patients, in order to
provide our patients with the best possible care. The purpose of our study is thus to
determine which oxygen treatment is best for patients with acute worsening of COPD symptoms.
We will use a prospective, randomized controlled open-label trial. We will use two
treatments: Treatment 1 is giving oxygen to the patient to reach a peripheral oxygen
saturation of above 94%. Treatment 2 is giving oxygen to reach a peripheral oxygen saturation
of between 88% and 92%.
Our primary outcome is 30-day all-cause mortality, with secondary outcomes being 7-day
all-cause mortality, need for non-invasive ventilation, intubation or intensive care
admission, over-all length of hospital stay and respiratory acidosis.
We believe that a lower oxygen saturation percentage may be superior as one study (Austin et
al., 2010) showed a lower mortality rate in the group of patients that had a lower peripheral
oxygen saturation. Additionally, the risk of respiratory acidosis and hypercapnia were lower.
We wish to perform our study in the hospital sector as this study was performed in the
prehospital sector and thus their results cannot be translated directly.
Phase:
Phase 4
Details
Lead Sponsor:
Sydvestjysk Hospital
Collaborators:
Holbaek Sygehus Odense University Hospital Sygehus Lillebaelt