RECRUITING

Supplemental Oxygen in Pulmonary Embolism (SO-PE)

Talk to us

Conditions

Pulmonary EmbolismVenous ThromboembolismMetabolomicsOxygen Inhalation TherapyPulmonary Embolism, PE, RVD

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Supplemental Oxygen in Pulmonary Embolism (SO-PE)

Quick Facts

Study Start:2023-10-01
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05891886

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults ≥18 years old
  2. * Confirmed Pulmonary Embolism (PE) on computed tomography pulmonary angiography (CTPA) performed \<24 hours prior to enrollment
  3. * Symptom duration \<72 hours
  4. * Confirmation of right ventricular dysfunction (RVD) by clinician
  5. * Oxygen saturation ≥90% while breathing room air
  1. * Hemodynamic instability
  2. * Use of vasopressors or mechanical circulatory support
  3. * Planned use of thrombolytics or plan for embolectomy
  4. * Oxygen saturation \<90% while breathing room air at any time in the Emergency Department (ED)
  5. * New onset arrhythmia
  6. * History of pulmonary hypertension, chronic obstructive pulmonary disease (COPD), hypoventilation syndrome, or congestive heart failure (CHF) with left ventricular ejection fraction \<40%
  7. * Known pregnancy
  8. * Use of chronic oxygen therapy at baseline
  9. * Vasodilator medication used in the past 24 hours
  10. * Symptom onset ≥72 hours
  11. * Inability to wear a face mask
  12. * Technically inadequate baseline echocardiogram
  13. * Temperature \>39° C
  14. * Positive test for Covid-19 or influenza within the previous 10 days

Contacts and Locations

Study Contact

Christopher Kabrhel, MD, MPH
CONTACT
617-726-7622
ckabhrel@partners.org
Blair A Parry, CCRC, BA
CONTACT
617-724-4758
bparry@mgh.harvard.edu

Principal Investigator

Christopher Kabrhel, MD, MPH
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Christopher Kabrhel, MD, MPH, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-01
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2023-10-01
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • Pulmonary Embolism, PE, RVD

Additional Relevant MeSH Terms

  • Pulmonary Embolism
  • Venous Thromboembolism
  • Metabolomics
  • Oxygen Inhalation Therapy