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

N/ACompletedNCT02051439

Mahidol University40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Varicose Veins Venous Insufficiency

Interventions

ValsavaPROCEDURE

The patients were randomized to 2 groups. The first group performed conventional Valsava 3 times before balloon assisted Valsava 3 times. The second group performed balloon assisted Valsava 3 times before conventional Valsava 3 times for venous reflux examination by duplex scan.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Number of successfully identified reflux with different method of Valsava technic

Patients performed conventional Valsava for identify venous reflux on duplex scan for 3 times then they performed balloon assisted Valsava for identify venous reflux on duplex scan for 3 times. The Outcome is number of successfully identified reflux with different method of Valsava technic.

Time frame: 20 minutes

Secondary Outcomes

The timing for the instruction of conventional Valsava and balloon assisted Valsava

The time for training patients to performed conventional Valsava and balloon assisted Valsava before duplex examination was compared

Time frame: 20 minutes

The timing of identified venous reflux demonstrated in the duplex scan of conventional Valsava and balloon assisted Valsava

The time of identified venous reflux demonstrated in the duplex scan of conventional Valsava and balloon assisted Valsava was compared

Time frame: 20 minutes

The total timing for duplex scan examination in conventional Valsava and balloon assisted Valsava

The total timing for duplex scan examination in conventional Valsava and balloon assisted Valsava was compared

Time frame: 20 minutes

Data from ClinicalTrials.gov

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