Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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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.

Official Title
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Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease

Conditions
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COPD Exacerbation, COPD Exacerbation Acute

Intervention / Treatment
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* Drug: Titrated Oxygen
* Drug: Standard Oxygen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Interventional, prospective, randomized 1:1, parallel groups, patient blinded, prehospital, single center, acute, superiority trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Titrated Oxygen<br>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<br>* Titrated oxygen strategy - a mix of supplemental oxygen and compressed atmospheric air as driver for inhaled bronchodilators to target SpO2 88-92%<br>|
| Active Comparator: Standard Oxygen<br>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<br>* Standard care using compressed oxygen (100%) as driver for inhaled bronchodilators<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 (non-invasive ventilation) within 24 hours |  | 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 | 
| The degree of acidosis based on the pH (potential of hydrogen) value |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Titrated Oxygen, COPD Exacerbation, Prehospital, COPD