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Oxygénothérapie standard vs ciblée Préhospitalier pour la maladie pulmonaire obstructive chronique (STOP-COPD)

30 septembre 2026 mis à jour par: Central Denmark Region

The STOP-COPD trial is a randomized, patient-blinded, prehospital clinical trial designed to evaluate the effect of titrated oxygen therapy compared to standard oxygen treatment in patients with suspected acute exacerbation of chronic obstructive pulmonary disease (AECOPD) treated with inhaled bronchodilators. The primary objective is to determine whether a titrated oxygen strategy targeting SpO₂ 88-92% can reduce 30-day mortality compared to the current standard practice using 100% compressed oxygen as a nebulizer driver.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality globally. In the prehospital setting, patients with suspected acute exacerbation of COPD (AECOPD) are frequently treated with inhaled bronchodilators driven by 100% oxygen, despite concerns that high-concentration oxygen therapy may worsen hypercapnia and acidosis, leading to increased mortality.

The STOP-COPD trial is a prospective, randomized, parallel-group, superiority trial conducted in the Prehospital Emergency Medical Services, Central Denmark Region. Patients aged 40 years or older with suspected AECOPD requiring inhaled bronchodilators are randomized 1:1 to receive either:

Titrated oxygen therapy: Inhaled bronchodilators driven by compressed air with supplemental oxygen titrated to maintain SpO₂ 88-92%.

Standard treatment: Inhaled bronchodilators driven by 100% compressed oxygen according to standard protocols.

The primary outcome is 30-day all-cause mortality. Secondary outcomes include 24-hour and 7-day mortality, need for invasive or non-invasive ventilation, development of respiratory acidosis upon hospital arrival, ICU admission rate, length of hospital and ICU stay, patient-experienced dyspnoea, and readmission rates. A total of 1,888 patients will be enrolled.

The study is conducted under emergency research regulations allowing enrolment before informed consent, with consent obtained as soon as feasible after hospital admission. This trial seeks to evaluate whether titrating oxygen delivery in the prehospital phase can improve survival and clinical outcomes for patients with AECOPD.

Type d'étude

Interventionnel

Inscription (Estimé)

1888

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Martin F Gude, PhD
  • Numéro de téléphone: 0045 25343621
  • E-mail: martgude@rm.dk

Sauvegarde des contacts de l'étude

  • Nom: Arne Sylvester R Jensen
  • Numéro de téléphone: 22396968
  • E-mail: arjens@rm.dk

Lieux d'étude

  • Danemark
      • Aarhus N, Danemark, 8200
        • Recrutement
        • Prehospital Emergency Medical Servises, Central Denmark Region

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

40 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: Titrated Oxygen

Titrated oxygen strategy - a mix of supplemental oxygen and compressed atmospheric air as driver for inhaled bronchodilators to target SpO2 88-92%

Autres noms:
  • Titration d'oxygène à Spo₂ 88-92% et à l'air atmosphérique comprimé comme pilote de nébuliseur
Comparateur actif: 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.
Médicament: Standard Oxygen

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

Autres noms:
  • Pas de restriction cible spo₂ et 100% d'oxygène comprimé comme pilote de nébuliseur

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Mortality, 30-day
Délai: Day 30 from randomization

Vital status assessed 30 days after randomization using hospital electronic medical records
Day 30 from randomization

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Mortality, 24-hour
Délai: 24 hours from randomization

Vital status assessed 24 hours after randomization using hospital electronic medical records
24 hours from randomization
Mortality, 7-day
Délai: Day 7 from randomization

Vital status assessed 7 days after randomization using hospital electronic medical records
Day 7 from randomization
Length of hospital stay
Délai: Day 30 from randomization

Number of days from hospital admission to hospital discharge, collected from hospital electronic medical records
Day 30 from randomization
ICU admission rate
Délai: Day 30 from randomization

Proportion of patients admitted to an intensive care unit during the index hospitalization, collected from the electronic hospital medical record
Day 30 from randomization
Length of ICU stay
Délai: Day 30 from randomization

Number of days spent in the intensive care unit during the index hospitalization, collected from the patient's electronic hospital medical record
Day 30 from randomization
In-hospital need for NIV (non-invasive ventilation) within 24 hours
Délai: Day 30 from randomization

Use of non-invasive ventilation recorded within 24 hours of hospital admission, collected from the patient's electronic hospital medical record
Day 30 from randomization
In-hospital need for NIV within 7 days
Délai: Day 30 from randomization

Use of non-invasive ventilation recorded within 7 days of hospital admission, collected from the patient's electronic hospital medical record
Day 30 from randomization
In-hospital need for NIV within 30 days
Délai: Day 30 from randomization

Use of non-invasive ventilation recorded within 30 days of randomization, collected from the patient's electronic hospital medical record
Day 30 from randomization
Time to NIV
Délai: Day 30 from randomization

Time from hospital admission to initiation of non-invasive ventilation, collected from the patient's electronic hospital medical record
Day 30 from randomization
In-hospital need for invasive mechanical ventilation within 24 hours
Délai: Day 30 from randomization

Initiation of invasive mechanical ventilation within 24 hours of hospital admission, collected from the patient's electronic hospital medical record
Day 30 from randomization
In-hospital need for invasive mechanical ventilation within 7 days
Délai: Day 30 from randomization

Initiation of invasive mechanical ventilation within 7 days of hospital admission, collected from the patient's electronic hospital medical record
Day 30 from randomization
In-hospital need for invasive mechanical ventilation within 30 days
Délai: Day 30 from randomization

Initiation of invasive mechanical ventilation within 30 days of randomization, collected from the patient's electronic hospital medical record
Day 30 from randomization
Time to invasive ventilation
Délai: Day 30 from randomization

Time from hospital admission to initiation of invasive mechanical ventilation, collected from the patient's electronic hospital medical record
Day 30 from randomization
Proportion of patients with respiratory acidosis on arrival to hospital
Délai: Day 30 from randomization

Presence of respiratory acidosis (PaCO₂ >6.3 kPa and pH <7.35) assessed via arterial blood gas analysis within 30 minutes after arrival, collected from the patient's electronic hospital medical record
Day 30 from randomization
The degree of acidosis based on the pH (potential of hydrogen) value
Délai: Day 30 from randomization

Lowest pH value measured from arterial blood gas within 30 minutes of hospital arrival, collected from the patient's electronic hospital medical record
Day 30 from randomization
Patient experienced dyspnoea on a verbal rating scale 0-10
Délai: Day 30 from randomization

Patient-reported dyspnoea score at hospital arrival on a scale from 0 (no dyspnoea) to 10 (worst imaginable dyspnoea), collected from the prehospital patient record and hospital medical record
Day 30 from randomization
Readmission rate
Délai: Day 30 after discharge

Proportion of patients readmitted to hospital within 30 days after discharge from index hospitalization, collected from the patient's electronic hospital medical record
Day 30 after discharge
Time to readmission
Délai: Day 30 after discharge

Number of days from hospital discharge to first hospital readmission within 30 days, collected from the patient's electronic hospital medical record
Day 30 after discharge

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Central Denmark Region

Les enquêteurs

  • Chercheur principal: Martin F Gude, PhD, Central Denmark Region

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

2 juin 2025

Achèvement primaire (Estimé)

29 février 2028

Achèvement de l'étude (Estimé)

31 mai 2028

Dates d'inscription aux études

Première soumission

10 janvier 2023

Première soumission répondant aux critères de contrôle qualité

19 janvier 2023

Première publication (Réel)

30 janvier 2023

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 5925
  • 2022-502003-30-00 (Autre identifiant: https://euclinicaltrials.eu)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

De-identified individual participant data (IPD) will be made available to researchers whose proposed use of the data has been approved by the local administration. Data will be shared starting 9 months after publication of the primary results and will be accessible until data are no longer stored, according to current ICMJE recommendations and EU data protection regulations.

All trial-related documents (e.g., protocol, statistical analysis plan) will be made publicly available on the trial website. Patient-related data will not be accessible on the website.

Délai de partage IPD

9 months after primary results publication; data will remain available until de-identified data are no longer stored according to ICMJE recommendations and EU regulations.

Critères d'accès au partage IPD

Researchers must submit a methodologically sound proposal for use of the data. Access will be granted following review and approval by the local trial administration. A data-sharing agreement will be required.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • ANALYTIC_CODE
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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