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

Phase 4

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease Exacerbation; COPD Exacerbation
• Interventions: Drug: Oxygen gas

• Registration Number: NCT04223050
• Lead Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark

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.

Study Timeline

• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-07
• Study First Posted: 2020-01-10
• Study Start: 2020-02-03
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-01
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 415

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High oxygen saturation	Oxygen gas	Peripheral oxygen saturation level \>94%
Low oxygen saturation	Oxygen gas	Peripheral oxygen saturation level 88-92%

Primary Outcome Measures

Name	Time	Method
30-day all-cause mortality	30 days	Data is extracted from the Danish national registries.

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Sydvestjysk Sygehus; 🇩🇰 Esbjerg, Denmark

Holbæk Sygehus; 🇩🇰 Holbæk, Denmark

Sygehus Lillebælt, Kolding; 🇩🇰 Kolding, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark