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Air Versus Oxygen for Intermediate-Risk Pulmonary Embolism (AIRE) (AIRE)

Primary Purpose

Pulmonary Embolism

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Oxygen gas
Sponsored by
Ministry of Health, Spain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed PE by multidetector computed tomographic pulmonary angiography (MDCT).
  • Disfunction of right ventricle (RV to left ventricle [LV] diameter ratio >1.0 in the apical 4-chamber view) in the echocardiogram performed in the first 12 hours after PE diagnosis.
  • Signed and dated informed consent of the subject.

Exclusion Criteria:

  • <18 years old.
  • Allergy to iodinated contrast.
  • Renal failure defined as a creatinine clearance less than 30 mL/min, according to the Cockcroft-Gault formula.
  • Use of chronic oxygen therapy.
  • Hypercapnia (pCO2 >50 mmHg at the time of diagnosis).
  • Technically inadequate basal echocardiography.
  • Contraindication to anticoagulant therapy.
  • Symptoms duration >10 days.
  • Haemodynamic instability.
  • Participation in other clinical trial for PE treatment during the present clinical trial.
  • Inability to use mask or nasal prongs.
  • Life expectancy less than 90 days.

Sites / Locations

  • Hospital Universitario Araba
  • Hospital Galdakao-Usansolo
  • Hospital Clínic de Barcelona
  • Clínica Universidad de Navarra
  • Hospital Universitario Ramón y Cajal
  • Hospital Universitario Virgen del Rocío
  • Hospital Universitario y Politécnico La Fe

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Supplementary oxygen

Standard medical therapy

Arm Description

Supplementary oxygen added to conventional anticoagulant treatment.

Standard management.

Outcomes

Primary Outcome Measures

Normal right ventricle function at 48 hours
Right ventricle (RV) to left ventricle (LV) diameter ratio equal or less than 1.0 measured 48 hours after initiation of therapy in normotensive patients with intermediate-risk pulmonary embolism (PE).

Secondary Outcome Measures

Modification RV -LV 7 days
Modification of the right ventricle (RV) to the left ventricle (LV) diameter ratio measured 7 days after initiation of therapy in normotensive patients with intermediate-risk pulmonary embolism (PE).

Full Information

First Posted
June 27, 2019
Last Updated
August 17, 2022
Sponsor
Ministry of Health, Spain
Collaborators
Sociedad Española de Neumología y Cirugía Torácica
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1. Study Identification

Unique Protocol Identification Number
NCT04003116
Brief Title
Air Versus Oxygen for Intermediate-Risk Pulmonary Embolism (AIRE)
Acronym
AIRE
Official Title
Randomized Clinical Trial to Evaluate the Efficacy and Safety of the Treatment With Supplementary Oxygen in Patients With Intermediate-Risk Pulmonary Embolism (PE)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 11, 2019 (Actual)
Primary Completion Date
April 24, 2022 (Actual)
Study Completion Date
July 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health, Spain
Collaborators
Sociedad Española de Neumología y Cirugía Torácica

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective is to evaluate the efficacy of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with Intermediate-risk pulmonary embolism. The secondary objective is to evaluate the safety of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with Intermediate-risk pulmonary embolism.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supplementary oxygen
Arm Type
Experimental
Arm Description
Supplementary oxygen added to conventional anticoagulant treatment.
Arm Title
Standard medical therapy
Arm Type
No Intervention
Arm Description
Standard management.
Intervention Type
Drug
Intervention Name(s)
Oxygen gas
Intervention Description
Supplementary oxygen during the first 48 hours added to conventional anticoagulant treatment. Patients will receive anticoagulant treatment according to updated guidelines.
Primary Outcome Measure Information:
Title
Normal right ventricle function at 48 hours
Description
Right ventricle (RV) to left ventricle (LV) diameter ratio equal or less than 1.0 measured 48 hours after initiation of therapy in normotensive patients with intermediate-risk pulmonary embolism (PE).
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Modification RV -LV 7 days
Description
Modification of the right ventricle (RV) to the left ventricle (LV) diameter ratio measured 7 days after initiation of therapy in normotensive patients with intermediate-risk pulmonary embolism (PE).
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed PE by multidetector computed tomographic pulmonary angiography (MDCT). Disfunction of right ventricle (RV to left ventricle [LV] diameter ratio >1.0 in the apical 4-chamber view) in the echocardiogram performed in the first 12 hours after PE diagnosis. Signed and dated informed consent of the subject. Exclusion Criteria: <18 years old. Allergy to iodinated contrast. Renal failure defined as a creatinine clearance less than 30 mL/min, according to the Cockcroft-Gault formula. Use of chronic oxygen therapy. Hypercapnia (pCO2 >50 mmHg at the time of diagnosis). Technically inadequate basal echocardiography. Contraindication to anticoagulant therapy. Symptoms duration >10 days. Haemodynamic instability. Participation in other clinical trial for PE treatment during the present clinical trial. Inability to use mask or nasal prongs. Life expectancy less than 90 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Jiménez
Organizational Affiliation
IRYCIS, Alcala de Henares University
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitario Araba
City
Vitoria
State/Province
Alava
Country
Spain
Facility Name
Hospital Galdakao-Usansolo
City
Galdakao
State/Province
Vizcaya
Country
Spain
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
Country
Spain
Facility Name
Clínica Universidad de Navarra
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
Country
Spain
Facility Name
Hospital Universitario y Politécnico La Fe
City
Valencia
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Air Versus Oxygen for Intermediate-Risk Pulmonary Embolism (AIRE)

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