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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Comparison of the Party Balloon Assisted Valsalva With Conventional Valsalva Maneuver in Diagnosis of Superficial Venous Valvular Reflux of Lower Limb

Conditions
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Varicose Veins, Venous Insufficiency

Intervention / Treatment
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* Procedure: Valsava


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Valsava<br>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. | Procedure: Valsava<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 20 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Varicose Veins, Venous Insufficiency, Doppler, Duplex, Valsava