Patient collective and study design
pulmonary artery embolism, breathing impairment, MM
HEARING IMPAIRMENT, PULMONARY ARTERY EMBOLISM
In our prospective, institutional-review-board-approved (2019-400 M-§23bMPG) single-center study, patients with suspected pulmonary artery embolism were enrolled and randomly assigned into two groups (MM and SBC) with different breathing maneuvers during routine CTPA. Patients were enrolled based on the following criteria: Age  ≥ 18 years and clinical indication for CTPA due to suspected PE. Exclusion criteria were the inability of informed consent, i.v. access at the lower extremity, insurmountable language barriers, severe hearing impairment, very severe breathing impairment, or lack of compliance. Patients were randomized to either device-assisted MM or SBC 1:1. For all patients, written informed consent was obtained and evaluation of imaging results was performed after anonymization. The data was also evaluated with regard to subjective and objective image quality measures.The MM was performed using a specially designed and patented prototype breathing assistance device system (Contrast Booster™ System, Ulrich GmbH & Co. KG) which allows both the patient and the examiner to monitor the correct performance of the Mueller maneuver throughout the CT scan.