Pulmonary vascular disease & thromboembolism
The rationale, design, and methods of a trial to evaluate the efficacy and safety of oxygen therapy in patients with intermediate-risk acute pulmonary embolism
Authors' conclusion
This multicenter trial will provide information about the value of supplemental oxygen in patients with intermediate-risk acute PE who do not have hypoxemia at baseline.
Study context
- Population
- Patients hospitalised with intermediate-risk acute pulmonary embolism (PE) without hypoxaemia (oxygen saturation ≥90%) at baselineplanned enrolment
- Participants
- 90 patients
- Comparison
- Supplemental oxygen vs ambient air
- Primary endpoint
- RV/LV diameter ratio ≤1.0 on echocardiography
- Follow-up
- 48 hours after start of treatment
Methodological detailsAIR, prospective, multicentre, open-label, parallel-group, proof-of-concept, 1:1 randomisation, Enrolment started July 2019, expected to continue until 2022, Clinical adverse events collected, Secondary efficacy outcomes: change in right ventricular (RV)/LV diameter ratio from baseline at 48 hours and 7 days
- AIR
- Prospective
- Multicentre
- Open-label
- Parallel-group
- Proof-of-concept
- 1:1 randomisation
- Enrolment started July 2019, expected to continue until 2022
- Clinical adverse events collected
- Secondary efficacy outcomes: change in RV/LV diameter ratio from baseline at 48 hours and 7 days
Primary result
As reported in the abstract
- Trial design paper; no outcome results reported
Secondary outcomes
Baseline characteristics of first 50 patients
- Median age
- 74 years (IQR 61-81)
- Female
- 50%
Original publication
The rationale, design, and methods of a trial to evaluate the efficacy and safety of oxygen therapy in patients with intermediate-risk acute pulmonary embolism. Am Heart J. Published 24 November 2022. doi:10.
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