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Идёт набор NCT05891886

Supplemental Oxygen in Pulmonary Embolism (SO-PE)

Ранняя фаза I С лечением Pulmonary Embolism Venous Thromboembolism Metabolomics Oxygen Inhalation Therapy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Oxygen Therapy, Non-rebreather mask.
Кому может быть актуально
Состояния в реестре: Pulmonary Embolism, Venous Thromboembolism, Metabolomics, Oxygen Inhalation Therapy. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

A study of how supplemental oxygen helps patients with acute pulmonary embolism (PE). Hypothesis: Oxygen affects right ventricular dysfunction (RVD) in patients with acute pulmonary embolism (PE) primarily by relieving hypoxic pulmonary vasoconstriction and reducing pulmonary pressure (PA) pressure, and that this process is metabolically driven.

Подробное описание

In the Emergency Department (ED), investigators will perform a randomized, crossover trial of adult patients with acute PE.

Study subjects will be randomized to one of two interventions (supplemental oxygen delivered by facemask) vs. room air. Therapy will be alternated at t=30, t=60, t=90 minutes, and then maintained for 180 minutes.

After each treatment change, and at 180 minutes, investigators will: 1) perform echocardiograms to determine how oxygen affects right ventricular dysfunction (RVD) and, 2) draw blood for metabolomic analyses to determine the metabolic pathways that change in response to oxygen therapy.

Вмешательства

  • Препарат Oxygen Therapy
    Study subjects will be asked to breathe supplemental, or extra, oxygen during several time periods.
  • Устройство Non-rebreather mask
    Non-rebreather mask is a non-invasive oxygen supplementation device that is used to provide continuous oxygen flow, typically in a hospital setting.

Первичные конечные точки

  • Pulmonary artery systolic pressure (PASP) [Срок оценки: 30 minutes after study treatment (supplemental oxygen) or placebo (room air)]
  • Pulmonary artery systolic pressure (PASP) [Срок оценки: 60 minutes after study treatment (supplemental oxygen) or placebo (room air)]
  • Pulmonary artery systolic pressure (PASP) [Срок оценки: 90 minutes after study treatment (supplemental oxygen) or placebo (room air)]
  • Pulmonary artery systolic pressure (PASP) [Срок оценки: 180 minutes after study treatment (supplemental oxygen) or placebo (room air)]
Вторичные конечные точки (8)
  • Right ventricular to left ventricular ratio (RV/LV) [Срок оценки: 30 minutes after study treatment (supplemental oxygen) or placebo (room air)]
  • Right ventricular to left ventricular ratio (RV/LV) [Срок оценки: 60 minutes after study treatment (supplemental oxygen) or placebo (room air)]
  • Right ventricular to left ventricular ratio (RV/LV) [Срок оценки: 90 minutes after study treatment (supplemental oxygen) or placebo (room air)]
  • Right ventricular to left ventricular ratio (RV/LV) [Срок оценки: 180 minutes after study treatment (supplemental oxygen) or placebo (room air)]
  • Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays [Срок оценки: 30 minutes after study treatment (supplemental oxygen) or placebo (room air)]
  • Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays [Срок оценки: 60 minutes after study treatment (supplemental oxygen) or placebo (room air)]
  • Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays [Срок оценки: 90 minutes after study treatment (supplemental oxygen) or placebo (room air)]
  • Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays [Срок оценки: 180 minutes after study treatment (supplemental oxygen) or placebo (room air)]

Критерии участия

Критерии включения

  • Adults ≥18 years old
  • Confirmed Pulmonary Embolism (PE) on imaging <24 hours prior to enrollment
  • New symptom onset and / or worsening symptoms <72 hours
  • Confirmation of right ventricular dysfunction (RVD) by clinician
  • Oxygen saturation ≥90% while breathing room air

Критерии исключения

  • Hemodynamic instability
  • Use of vasopressors or mechanical circulatory support
  • Planned use of thrombolytics or plan for embolectomy
  • Oxygen saturation <90% while breathing room air
  • New onset arrhythmia
  • History of pulmonary hypertension, severe chronic obstructive pulmonary disease (COPD) requiring home oxygen or chronic steroid use, hypoventilation syndrome requiring continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP), or congestive heart failure (CHF) with LV ejection fraction < 40% or chronic oxygen therapy
  • Known pregnancy
  • Vasodilator medication used in the past 24 hours
  • Symptom onset ≥72 hours
  • Inability to wear a face mask
  • Inability to obtain adequate baseline echocardiogram

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Другое

Центры проведения

США · 1 центр
  • Massachusetts General Hospital — Boston

Публикации

  • Lyhne MD, Liteplo AS, Zeleznik OA, Dudzinski DM, Andersen A, Shokoohi H, Al Jalbout N, Eke OF, Morone CC, Huang CK, Heyne TF, Kalra MK, Kabrhel C. Supplemental oxygen for pulmonary embolism (SO-PE): study protocol for a mechanistic, randomised, blinded, cross-over study. BMJ Open. 2024 Nov 12;14(11):e091567. doi: 10.1136/bmjopen-2024-091567. PMID 39532350

Идентификаторы

NCT: NCT05891886 · 2023P000252

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗