The Party Balloon Assisted Valsalva in Diagnosis of Superficial Venous Valvular Reflux of Lower Limb

Mahidol University

Status: Completed

Conditions: Venous Insufficiency; Varicose Veins

Treatments: Procedure: Valsava

Study type: Interventional

Funder types: Other

Identifiers

NCT02051439

SIRIRAJ11SU00030/028/11

Details and patient eligibility

About

This study was designed to compare the party balloon assisted Valsalva with the conventional Valsava for exhibiting the reverse venous flow in superficial venous valvular incompetence duplex examination.

Full description

In this study, we compared the Party Balloon assisted Valsalva with Conventional Valsalva maneuver in diagnosis of superficial venous valvular reflux of lower limb by crossover study.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age within 18-80 years old
• Visible GSV varicose veins
• Trendelenburg test part 1 - Negative (Perforator vein incompetence) and
• Trendelenburg test part 2 - Positive (Saphenofemoral junction competence)
• Consent to participate in the study.

Exclusion criteria

• • CVI from Klippel-Trenaunay syndrome, Deep vein thrombosis (DVT), Arteriovenous fistula (AVF)
• Failure to language communication
• Previous heart disease (CAD, Myocardial infarction, Stable angina, Unstable angina, Congestive Heart Failure, Valvular heart disease)
• Previous lung disease (Asthma, Chronic obstructive pulmonary disease, Bronchiectasia)
• Abnormalities of oral cavity which cannot hold own breath. (Cleft lip, Cleft palate)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Valsava

Other group

Description:

The patients were randomized to 2 groups. The first group performed conventional Valsava before balloon assisted Valsava. The second group performed balloon assisted Valsava before conventional Valsava for venous reflux examination by duplex scan.

Treatment:

Procedure: Valsava