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

NCT ID: NCT04223050

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 415 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-03
• Study Completion Date: 2024-08-31

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.

Conditions

COPD Exacerbation; Chronic Obstructive Pulmonary Disease Exacerbation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High oxygen saturation

Peripheral oxygen saturation level \>94%

Group Type: ACTIVE_COMPARATOR

Oxygen gas

Intervention Type: DRUG

Administering oxygen to achieve the desired peripheral oxygen saturation

Low oxygen saturation

Peripheral oxygen saturation level 88-92%

Group Type: ACTIVE_COMPARATOR

Oxygen gas

Intervention Type: DRUG

Administering oxygen to achieve the desired peripheral oxygen saturation

Interventions

Oxygen gas

Administering oxygen to achieve the desired peripheral oxygen saturation

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Holbaek Sygehus

OTHER

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: collaborator

Sygehus Lillebaelt

OTHER

Sponsor Role: collaborator

Esbjerg Hospital - University Hospital of Southern Denmark

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Hallas, MD

Role: PRINCIPAL_INVESTIGATOR

Holbaek Sygehus

Sune Laugesen, MD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Simon Thorgaard-Rasmussen, MD

Role: PRINCIPAL_INVESTIGATOR

Sygehus Lillebælt, Kolding

Locations

Sydvestjysk Sygehus

Esbjerg, , Denmark

Site Status: RECRUITING

Holbæk Sygehus

Holbæk, , Denmark

Site Status: NOT_YET_RECRUITING

Sygehus Lillebælt, Kolding

Kolding, , Denmark

Site Status: NOT_YET_RECRUITING

Odense University Hospital

Odense, , Denmark

Site Status: NOT_YET_RECRUITING

Countries

Denmark

Central Contacts

Mikkel Brabrand, MD PhD

Role: CONTACT

mikkel.brabrand@rsyd.dk

+45 7918 5934

Line E. Lilholm Laugesen, MScPH

Role: CONTACT

Line.Emilie.Lilholm.Laugesen@rsyd.dk

+45 7918 5934

Facility Contacts

Mikkel Brabrand, MD PhD

Role: primary

mikkel.brabrand@rsyd.dk

+45 7918 5934

Peter Hallas, MD

Role: primary

phaa@regionsjaelland.dk

59 48 38 01

Simon Thorgaard-Rasmussen, MD

Role: primary

Simon.Thorgaard-Rasmussen@rsyd.dk

Sune Laugesen, MD

Role: primary

Sune.Laugesen@rsyd.dk

Other Identifiers

19/4298

Identifier Type: REGISTRY

Identifier Source: secondary_id

2019-002498-80

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2019-002498-80

Identifier Type: -

Identifier Source: org_study_id