Optimization of Party Balloon Inflation Maneuver in Transthoracic Echocardiography

UMIN ID: UMIN000054423

Registered date:01/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: patent foramen ovale, hypertrophic obstructive cardiomyopathy
• Date of first enrollment: 2023/12/23
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Valsalva maneuver
Party balloon maneuver using smaller baloon inflated to a diameter of 5cm
Party balloon maneuver using smaller baloon inflated to a diameter of 15cm
Party balloon maneuver using larger baloon inflated to a diameter of 7cm
Party balloon maneuver using larger baloon inflated to a diameter of 15cm

Outcome(s)

• Primary Outcome: Basic Measurement of Balloons Using several commercially available balloons of various sizes, measure the lateral diameter of the inflated balloons using calipers. Additionally, measure the air pressure of each balloon with an air pressure gauge to determine the optimal balloon size and degree of inflation for the load. Transthoracic Echocardiography Healthy adult volunteers will be included in the study. Two experienced physicians (one male and one female) specializing in echocardiography will use transthoracic echocardiography in the left lateral position in the Physiology Laboratory of the Central Laboratory of our institution. The hemodynamic effects of the party balloon maneuver were investigated using the protocol obtained from Experiment 1. This was compared to rest and the Valsalva maneuver (VM) using transthoracic echocardiography. Right ventricular inflow-velocity time integral (RV inflow-VTI) and left ventricular end-diastolic diameter (LVDd) were measured during and after the maneuver to assess changes in venous return. The various measurements were analyzed offline with images acquired after the examination.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Cases with respiratory or cardiac disease. Cases in which sufficient information necessary for analysis could not be obtained, and other cases deemed inappropriate by the investigator.

Related Information

• Primary Sponsor: Teikyo University
• Source(s) of Monetary Support: Self funding