Clinical trial NCT04223050: Comparing Mortality for Low vs High Peripheral Oxygen Saturation in COPD-patients With Acute Exacerbation
Official title: Will Titrated Oxygen Flow to a Peripheral Oxygen Saturation of 88-92% Compared With Oxygen Flow to a Saturation >94% Reduce Mortality in Chronic Obstructive Pulmonary Disease Patients With Acute Exacerbation? - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: COPD Exacerbation
Chronic Obstructive Pulmonary Disease Exacerbation
Keywords: COPD
Oxygen treatment
Mortality
Lead sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Holbaek Sygehus
name: Odense University Hospital
name: Sygehus Lillebaelt
First posted: 2020-01-10
Enrollment: 415
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization will be performed as block randomization with a 1:1 allocation using an electronic randomization system accessible via the internet (REDCap via OPEN at the University of Southern Denmark). The participants will be randomized electronically bedside by the study representatives.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Please refer to the full protocol.

Eligibility criteria: Inclusion Criteria:

* age 18 years or older
* ability to give informed consent
* previously diagnosed COPD (either confirmed diagnosis at prior hospital - contact or from their general practitioner or confirmed diagnosis by the treating physician in the emergency department (verified by use of relevant medication))
* admitted with acute exacerbation (acute and worsened shortness of breath) of COPD
* requiring oxygen treatment

Exclusion Criteria:

* Instability at arrival requiring immediate lifesaving treatment, e.g. intubation or non-invasive ventilation, within the first 30 minutes
* Expected total length of stay in hospital \< 12 hours
* Planned transfer to another hospital within 12 hours
* Unwilling to have repeated arterial blood gas analyses within the first 12 hours
* Patients judged terminal by treating physician in the emergency department
* Non-residents of the particular country
* Expected impossible follow-up
* Fertile women (\<50 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG
* Prior participation in the study

Primary outcomes:
measure: 30-day all-cause mortality
timeFrame: 30 days
Secondary outcomes:
measure: 7-day all-cause mortality
timeFrame: 7 days
measure: Non-invasive ventilation
timeFrame: 12 hours
measure: Intubation
timeFrame: 12 hours
measure: Intensive care admission
timeFrame: 1 day
measure: Overall length of hospital stay
timeFrame: 10 days
measure: Respiratory acidosis
timeFrame: 12 hours
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Sydvestjysk Sygehus
city: Holbæk
country: Denmark
facility: Holbæk Sygehus
city: Kolding
country: Denmark
facility: Sygehus Lillebælt, Kolding
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Holbaek Sygehus
name: Peter Hallas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Odense University Hospital
name: Sune Laugesen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sygehus Lillebælt, Kolding
name: Simon Thorgaard-Rasmussen, MD
role: PRINCIPAL_INVESTIGATOR
References: