search
Back to results

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

Primary Purpose

COPD Exacerbation, COPD Exacerbation Acute

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Titrated Oxygen
Standard Oxygen
Sponsored by
Central Denmark Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD Exacerbation focused on measuring Titrated Oxygen, COPD Exacerbation, Prehospital, COPD

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Titrated Oxygen

    Standard Oxygen

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Mortality, 30-day

    Secondary Outcome Measures

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

    Full Information

    First Posted
    January 10, 2023
    Last Updated
    August 27, 2023
    Sponsor
    Central Denmark Region
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05703919
    Brief Title
    Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease
    Acronym
    STOP-COPD
    Official Title
    Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    September 30, 2025 (Anticipated)
    Study Completion Date
    January 8, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Central Denmark Region

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COPD Exacerbation, COPD Exacerbation Acute
    Keywords
    Titrated Oxygen, COPD Exacerbation, Prehospital, COPD

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Interventional, prospective, randomized 1:1, parallel groups, patient blinded, prehospital, single center, acute, superiority trial
    Masking
    Participant
    Masking Description
    The trial will be single blinded. The patients will be blinded to treatment allocation. The EMTs (emergency medical technicians) or paramedics will not be blinded because of practical, ethical and security problems with carrying compressed gas without known content in an ambulance. As part of study informed and training, the EMT's and paramedics will be attentive to keep all AECOPD suspected patients blinded to the treatment allocated.
    Allocation
    Randomized
    Enrollment
    1888 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Titrated Oxygen
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Standard Oxygen
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Titrated Oxygen
    Intervention Description
    Titrated oxygen strategy - a mix of supplemental oxygen and compressed atmospheric air as driver for inhaled bronchodilators to target SpO2 88-92%
    Intervention Type
    Drug
    Intervention Name(s)
    Standard Oxygen
    Intervention Description
    Standard care using compressed oxygen (100%) as driver for inhaled bronchodilators
    Primary Outcome Measure Information:
    Title
    Mortality, 30-day
    Time Frame
    Day 30 from randomization
    Secondary Outcome Measure Information:
    Title
    Mortality, 24-hour
    Time Frame
    Day 30 from randomization
    Title
    Mortality, 7-day
    Time Frame
    Day 30 from randomization
    Title
    Length of hospital stay
    Time Frame
    Day 30 from randomization
    Title
    ICU admission rate
    Time Frame
    Day 30 from randomization
    Title
    Length of ICU stay
    Time Frame
    Day 30 from randomization
    Title
    In-hospital need for NIV (non-invasive ventilation) within 24 hours
    Time Frame
    Day 30 from randomization
    Title
    In-hospital need for NIV within 7 days
    Time Frame
    Day 30 from randomization
    Title
    In-hospital need for NIV within 30 days
    Time Frame
    Day 30 from randomization
    Title
    Time to NIV
    Time Frame
    Day 30 from randomization
    Title
    In-hospital need for invasive mechanical ventilation within 24 hours
    Time Frame
    Day 30 from randomization
    Title
    In-hospital need for invasive mechanical ventilation within 7 days
    Time Frame
    Day 30 from randomization
    Title
    In-hospital need for invasive mechanical ventilation within 30 days
    Time Frame
    Day 30 from randomization
    Title
    Time to invasive ventilation
    Time Frame
    Day 30 from randomization
    Title
    Proportion of patients with respiratory acidosis on arrival to hospital
    Time Frame
    Day 30 from randomization
    Title
    The degree of acidosis based on the pH (potential of hydrogen) value
    Time Frame
    Day 30 from randomization
    Title
    Patient experienced dyspnoea on a verbal rating scale 0-10
    Time Frame
    Day 30 from randomization
    Title
    Readmission rate
    Time Frame
    Day 30 after discharge
    Title
    Time to readmission
    Time Frame
    Day 30 after discharge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Martin F Gude, PhD
    Phone
    0045 25343621
    Email
    martgude@rm.dk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Arne Sylvester R Jensen
    Phone
    22396968
    Email
    arjens@rm.dk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Martin F Gude, PhD
    Organizational Affiliation
    Central Denmark Region
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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.

    Learn more about this trial

    Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease

    We'll reach out to this number within 24 hrs