Substudy of Protocol 2019-002498-80 - NCT04223050: Comparing Mortality for Low vs High Peripheral Oxygen Saturation in COPD-patients With Acute Exacerbation (O2flow-COPD)

NCT05052125 | Terminated Phase 4 DMC

• 1 other identifier: 2019-002498-80 substudy
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

As protocol NCT04223050. This substudy furthermore investigates the role of oxidative stress in the administration of oxygen in COPD patients.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

oxygen; oxidative stress; mortality

Outcome Measures

Primary Outcomes (1)

• Oxidative stress levels (systemic and lung 8-isopropane levels).

  Immediately after study completion

Secondary Outcomes (4)

• Inflammation levels (systemic and lung IL-8 levels)

  Immediately after study completion

• 7-day all-cause mortality and 30-day all-cause mortality

  30 days

• over-all length of hospital stay

  Immediately after study completion

• respiratory acidosis

  Immediately after the procedure

Study Arms (2)

High oxygen saturation

ACTIVE COMPARATOR

Peripheral oxygen saturation level \>94% Intervention: Drug: Oxygen gas

Drug: Oxygen

Low oxygen saturation

ACTIVE COMPARATOR

Peripheral oxygen saturation level 88-92% Intervention: Drug: Oxygen gas

Drug: Oxygen

Interventions

Oxygen 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

• Mikkel Brabrand: lead
• Region of Southern Denmark: collaborator

Study Sites (2)

Hospital of Southern Denmark, Esbjerg

Esbjerg, 6700, Denmark

Location

Kolding Hospital, Sygehus Lillebælt

Kolding, 6000, Denmark

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Oxygen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, ph.d., MD

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 22, 2021
• Study Start: December 16, 2021
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 11, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)