Comparing Mortality for Low vs High Peripheral Oxygen Saturation in COPD-patients With Acute Exacerbation

COPD Exacerbation Clinical Trial

— O2flow-COPD  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04223050
• Other study ID #: 2019-002498-80
• Secondary ID: 19/42982019-0024
• Status: Recruiting
• Phase: Phase 4
• Start date: February 3, 2020
• Est. completion date: August 31, 2024

Study information

• Verified date: October 2022
• Source: Hospital of South West Jutland
• Contact: Mikkel Brabrand, MD PhD
• Phone: +45 7918 5934
• Email: mikkel.brabrand[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Please refer to the full protocol.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 415
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease Exacerbation
• COPD Exacerbation
• Disease Progression
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Oxygen gas
Administering oxygen to achieve the desired peripheral oxygen saturation

Locations

Country	Name	City	State
Denmark	Sydvestjysk Sygehus	Esbjerg
Denmark	Holbæk Sygehus	Holbæk
Denmark	Sygehus Lillebælt, Kolding	Kolding
Denmark	Odense University Hospital	Odense

Sponsors (4)

Lead Sponsor	Collaborator
Hospital of South West Jutland	Holbaek Sygehus, Odense University Hospital, Sygehus Lillebaelt

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day all-cause mortality	Data is extracted from the Danish national registries.	30 days
Secondary	7-day all-cause mortality	Data is extracted from the Danish national registries.	7 days
Secondary	Non-invasive ventilation	The Medical records will be reviewed for documentation on if the patient has been on non-invasive ventilation. This will be reported as proportion of patients on NIV	12 hours
Secondary	Intubation	The Medical records will be reviewed for documentation on if the patient has been intubated. This will be reported as proportion of patients intubated	12 hours
Secondary	Intensive care admission	Extracted from the hospital records.	1 day
Secondary	Overall length of hospital stay	Time calculated from the hospital records	10 days
Secondary	Respiratory acidosis	Measured as an arterial blood gas analysis with pH > 7.35 and hypercapnia	12 hours