Study to evaluate the use of supplemental oxygen in patients with acute symptomatic pulmonary embolism.

Phase 1

• Conditions: Acute symptomatic pulmonary embolism; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-000266-37-ES
• Lead Sponsor: Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-11
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1) Confirmed PE by multidetector computed tomographic pulmonary angiography (MDCT).
2) Disfuntion of right ventricle (quotient between RVDD and LVDD > 1.0 in the apical 4-chamber view) in the echocardiogram performed in the first 12 hours after PE diagnosis.
3) Signed and dated informed consent of the subject.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1)< 18 years old.
2)Allergy to iodinated contrast.
3)Renal failure defined as a creatinine clearance less than 30 mL/min, according to the Cockcroft-Gault formula.
4)Use of chronic oxygen therapy.
5)Hypercapnia (pCO2 >50 mmHg at the time of diagnosis).
6)Basal echocardiography technically unsuitable.
7)Contraindication to anticoagulant therapy.
8)Symptoms duration >10 days.
9)Haemodynamic instability.
10)Participation in other clinical trials for PE treatment during the present clinical trial.
11)Inability to use mask or nasal prongs.
12)Life expectancy less than 90 days.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the efficacy of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with Intermediate-Risk pulmonary embolism.;Secondary Objective: Evaluate the safety of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with Intermediate-Risk pulmonary embolism;Primary end point(s): Modification of the right ventricle (RV) to the left ventricle (LV) diameter ratio measured 48 hours after initiation of therapy;Timepoint(s) of evaluation of this end point: 48 hours

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Modification of the RV to the LV diameter ratio measured 7 days after initiation of therapy.;Timepoint(s) of evaluation of this end point: 7 days