Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease (STOP-COPD)

The goal of this clinical trial is to test titrated oxygen in prehospital patients with suspected acute exacerbation of chronic obstructive pulmonary disease (AECOPD) treated with inhaled bronchodilators. The main question it aims to answer is:

• To determine whether prehospital titrated oxygen strategy in patients with suspected AECOPD will decrease 30-day mortality compared to patients receiving standard care.

Participants in the intervention will receive titrated oxygen - a mix of supplemental oxygen and compressed atmospheric air as driver for inhaled bronchodilators to target SpO2 (oxygen saturation) 88-92%. The intervention will be compared to standard treatment, using compressed oxygen (100%) as driver for inhaled bronchodilators.

Study Overview

• Status: Not yet recruiting
• Conditions: COPD Exacerbation; COPD Exacerbation Acute
• Intervention / Treatment: Drug: Titrated Oxygen; Drug: Standard Oxygen

• Study Type: Interventional
• Enrollment (Estimated): 1888
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Martin F Gude, PhD; Phone Number: 0045 25343621; Email: martgude@rm.dk
• Study Contact Backup: Name: Arne Sylvester R Jensen; Phone Number: 22396968; Email: arjens@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients over the age of 40
• EMT or Paramedic suspected AECOPD
• Confirmed suspicion of COPD

Exclusion Criteria:

• Bronchospasm due to asthma, allergic reaction or non-COPD conditions
• Known or suspected pregnancy
• Prehospital Non-invasive, invasive or assisted bag mask ventilation
• Allergy to inhaled bronchodilators (Salbutamol)
• Inter-hospital transfer
• More than 2 doses (5 mg salbutamol) inhalation drug, acute treatment by EMS (emergency medical service) personnel, before allocated treatment is initiated
• Suspicion of acute coronary syndrome

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Titrated Oxygen; If the treating EMT or paramedic finds indications for inhaled bronchodilators, this will be done with compressed air 6-8 l/min. as the driver for the nebulizer. The patient will have a Bi-nasal EtCO2 (end-tidal carbon dioxide) meter placed under the nebulizer. This will measure the EtCO2 during the treatment and at the same time oxygen can be titrated through this to a target SpO2 of 88-92%. Repeated treatment will be at the discretion of the treating EMT or paramedic according to SOP (standard operating procedures). Following scenarios regarding SpO2 can occur during treatment: SpO2 <88%: Supplemental oxygen via the EtCO2-meter up to 10 l/min, if higher oxygen levels are needed oxygen will be used as driver for the nebulizer. If the SpO2 remains under 88% additional oxygen can be added via the EtCO2-meter. SpO2 88-92%: No intervention. SpO2 >92%: No intervention. If repeated treatment is not indicated the patient receives oxygen to SpO2 88-92% according SOP.	Drug: Titrated Oxygen; Titrated oxygen strategy - a mix of supplemental oxygen and compressed atmospheric air as driver for inhaled bronchodilators to target SpO2 88-92%
Active Comparator: Standard Oxygen; If the treating EMT or paramedic finds indication for inhaled bronchodilators, this will be done with oxygen 6-8 l/min. as the driver for the nebulizer. The patient will have a Bi-nasal EtCO2 meter placed under the nebulizer. This will measure the EtCO2 during the treatment and at the same time mask the patient for group allocation. Repeated treatment will be at the discretion of the treating EMT or paramedic according to SOP. Following scenarios regarding SpO2 can occur during treatment: SpO2 <88%: Supplemental oxygen via the EtCO2 -meter up to 10 l/min. SpO2 88-92%: No intervention. SpO2 >92%: No intervention. If repeated treatment is not indicated the patient receives oxygen to SpO2 88-92% according SOP.	Drug: Standard Oxygen; Standard care using compressed oxygen (100%) as driver for inhaled bronchodilators

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality, 30-day	Day 30 from randomization

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality, 24-hour	Day 30 from randomization
Mortality, 7-day	Day 30 from randomization
Length of hospital stay	Day 30 from randomization
ICU admission rate	Day 30 from randomization
Length of ICU stay	Day 30 from randomization
In-hospital need for NIV within 7 days	Day 30 from randomization
In-hospital need for NIV within 30 days	Day 30 from randomization
Time to NIV	Day 30 from randomization
In-hospital need for invasive mechanical ventilation within 24 hours	Day 30 from randomization
In-hospital need for invasive mechanical ventilation within 7 days	Day 30 from randomization
In-hospital need for invasive mechanical ventilation within 30 days	Day 30 from randomization
Time to invasive ventilation	Day 30 from randomization
Proportion of patients with respiratory acidosis on arrival to hospital	Day 30 from randomization
Patient experienced dyspnoea on a verbal rating scale 0-10	Day 30 from randomization
Readmission rate	Day 30 after discharge
Time to readmission	Day 30 after discharge
In-hospital need for NIV (non-invasive ventilation) within 24 hours	Day 30 from randomization
The degree of acidosis based on the pH (potential of hydrogen) value	Day 30 from randomization

Collaborators and Investigators

• Sponsor: Central Denmark Region
• Investigators: Principal Investigator: Martin F Gude, PhD, Central Denmark Region

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2028

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Actual): January 30, 2023

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: COPD; Prehospital; COPD Exacerbation; Titrated Oxygen
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 5925 (CTEP); 2022-502003-30-00 (Other Identifier: https://euclinicaltrials.eu)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

De-identified data will be made available for investigators whose proposed use of the data has been approved by local administration, 9 months after the publication and no longer accessible when data is no longer stored according to the current ICMJE (International Committee of Medical Journal Editors) recommendations and EU (European Union) regulations.

All trial-related documents will be publicly available at the trial-website www.STOP-COPD.com, patient related data will not be accessible on this website.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No