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NCT05703919 Clinical Trial

Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease

COPD Exacerbation Clinical Trial

— STOP-COPD  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05703919
Other study ID # 5925
Secondary ID 2022-502003-30-0
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date March 1, 2025
Est. completion date March 30, 2028

Study information
Verified date November 2023
Source Central Denmark Region
Contact Martin F Gude, PhD
Phone 0045 25343621
Email martgude@rm.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1888
Est. completion date March 30, 2028
Est. primary completion date March 30, 2027
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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%
• Standard Oxygen
Standard care using compressed oxygen (100%) as driver for inhaled bronchodilators

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Central Denmark Region

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