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

NCT04223050 | Terminated Phase 4 DMC

• 2 other identifiers: 2019-002498-8019/4298
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 4

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.

Conditions

COPD Exacerbation; Chronic Obstructive Pulmonary Disease Exacerbation

Keywords

COPD; Oxygen treatment; Mortality

Outcome Measures

Primary Outcomes (1)

• 30-day all-cause mortality

  Data is extracted from the Danish national registries.

  30 days

Secondary Outcomes (6)

• 7-day all-cause mortality

  7 days

• Non-invasive ventilation

  12 hours

• Intubation

  12 hours

• Intensive care admission

  1 day

• Overall length of hospital stay

  10 days

Study Arms (2)

High oxygen saturation

ACTIVE COMPARATOR

Peripheral oxygen saturation level \>94%

Drug: Oxygen gas

Low oxygen saturation

ACTIVE COMPARATOR

Peripheral oxygen saturation level 88-92%

Drug: Oxygen gas

Interventions

Oxygen gas DRUG

Administering oxygen to achieve the desired peripheral oxygen saturation

High oxygen saturation; Low oxygen saturation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Esbjerg Hospital - University Hospital of Southern Denmark: lead
• Holbaek Sygehus: collaborator
• Odense University Hospital: collaborator
• Sygehus Lillebaelt: collaborator

Study Sites (4)

Sydvestjysk Sygehus

Esbjerg, 6700, Denmark

Location

Holbæk Sygehus

Holbæk, 4300, Denmark

Location

Sygehus Lillebælt, Kolding

Kolding, 6000, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

nitrox

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Hallas, MD

  Holbaek Sygehus

  PRINCIPAL INVESTIGATOR

• Sune Laugesen, MD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

• Simon Thorgaard-Rasmussen, MD

  Sygehus Lillebælt, Kolding

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 10, 2020
• Study Start: February 3, 2020
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (4)