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

Who is this study for? Adult patients with COPD
What treatments are being studied? Oxygen gas
Status: Unknown
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Sydvestjysk Sygehus
RECRUITING
Esbjerg
Holbæk Sygehus
NOT_YET_RECRUITING
Holbæk
Sygehus Lillebælt, Kolding
NOT_YET_RECRUITING
Kolding
Odense University Hospital
NOT_YET_RECRUITING
Odense
Contact Information
Primary
Mikkel Brabrand, MD PhD
mikkel.brabrand@rsyd.dk
+45 7918 5934
Backup
Line E. Lilholm Laugesen, MScPH
Line.Emilie.Lilholm.Laugesen@rsyd.dk
+45 7918 5934
Time Frame
Start Date: 2020-02-03
Completion Date: 2024-08-31
Participants
Target number of participants: 415
Treatments
Active_comparator: High oxygen saturation
Peripheral oxygen saturation level \>94%
Active_comparator: Low oxygen saturation
Peripheral oxygen saturation level 88-92%
Sponsors
Leads: Esbjerg Hospital - University Hospital of Southern Denmark
Collaborators: Odense University Hospital, Sygehus Lillebaelt, Holbaek Sygehus

This content was sourced from clinicaltrials.gov