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- Essai clinique NCT01074983
Pre-hospital Hypoxemia in Trauma Patients
Prevalence of Pre-hospital Hypoxemia in Trauma Patients: Do Trauma Patients Need Oxygen?
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Trauma patients in the United States frequently receive high-flow high-concentration supplemental oxygen in the pre-hospital setting, yet their physiologic need is rarely known. Providing oxygen to everyone regardless of need may seem straightforward, but the practice has extensive implications in logistically challenging areas such as a combat arena or mass casualty event, and is not supported by care guidelines. Indeed, too much oxygen can be harmful for some patients.1, 2 If it is the case, that not all trauma patients require oxygen, this would decrease the logistical burden of providing oxygen in the pre-hospital environment. No study has yet been performed that describes the proportion of patients requiring oxygen, the amount of oxygen they require, and whether or not oxygen is beneficial to outcomes. This prospective observational cohort investigation aims to bridge the knowledge gap surrounding the need and possible benefits or harms arising from oxygen therapy. In our Emergency Medical Services (EMS) systems, the written standard of care is to provide oxygen only to maintain oxygen saturation at 95% or when hemorrhagic shock or traumatic brain injury are suspected.3 We will observe patterns of oxygen treatment and outcome for patients treated according to this written standard of care, and compare this to the treatment and outcomes for patients transported by EMS units who continue their usual practice pattern.
Specifically, we aim to:
- Identify the proportion of trauma patients who are hypoxemic or who have traumatic brain injury or hemorrhagic shock at the time of initial EMS contact
- Identify the proportion of trauma patients who develop hypoxemia or hemorrhagic shock while in the pre-hospital setting
- Identify differences in clinically important outcomes associated with treatments driven by written standard of care compared with the usual practice pattern of EMS units. These outcomes include requirement for advanced airway management, hospital and intensive care unit lengths of stay, and disposition (including in-hospital and 30-day mortality)
- Determine the amount of oxygen (Liters per minute) required to reverse hypoxemia
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Ohio
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Cincinnati, Ohio, États-Unis, 45267
- University Hospital
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- acute traumatic injury
- transported directly to study hospital
- meets at least one trauma consult/trauma stat criteria
Exclusion Criteria:
- lack of continuous peripheral pulse oximetry data
- age <18 years
- on prescribed home oxygen therapy prior to trauma
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
---|
Written standard of care
|
Usual practice pattern
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Proportion of trauma patients who are hypoxemic or who have traumatic brain injury or hemorrhagic shock at the time of initial emergency medical services (EMS) contact
Délai: At enrollment
|
At enrollment
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Proportion of trauma patients who develop hypoxemia or hemorrhagic shock while in the pre-hospital setting
Délai: at enrollment
|
at enrollment
|
Amount of oxygen required to correct hypoxemia
Délai: at enrollment
|
at enrollment
|
Clinically important outcomes associated with treatments driven by written standard of care compared with the usual practice pattern of EMS units
Délai: at study conclusion
|
at study conclusion
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jason T McMullan, MD, University of Cincinnati
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- FA8650-05-2-6518-661150
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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