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

Study Overview
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Brief Summary
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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
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Please refer to the full protocol.

Official Title
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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

Conditions
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COPD Exacerbation, Chronic Obstructive Pulmonary Disease Exacerbation

Intervention / Treatment
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* Drug: Oxygen gas


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High oxygen saturation<br>Peripheral oxygen saturation level >94% | Drug: Oxygen gas<br>* Administering oxygen to achieve the desired peripheral oxygen saturation<br>|
| Active Comparator: Low oxygen saturation<br>Peripheral oxygen saturation level 88-92% | Drug: Oxygen gas<br>* Administering oxygen to achieve the desired peripheral oxygen saturation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day all-cause mortality | Data is extracted from the Danish national registries. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day all-cause mortality | Data is extracted from the Danish national registries. | 7 days | 
| 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 | 
| 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 | 
| Intensive care admission | Extracted from the hospital records. | 1 day | 
| Overall length of hospital stay | Time calculated from the hospital records | 10 days | 
| Respiratory acidosis | Measured as an arterial blood gas analysis with pH > 7.35 and hypercapnia | 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Oxygen treatment, Mortality