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

Not Applicable

Completed

• Conditions: Varicose Veins; Venous Insufficiency
• Interventions: Procedure: Valsava

• Registration Number: NCT02051439
• Lead Sponsor: Mahidol University

Brief Summary

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

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 Timeline

• Study Start: 2012-01
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2014-01
• Study First Submitted: 2014-01-27
• Study First Submitted QC: 2014-01-29
• Last Update Submitted: 2014-01-29
• Study First Posted: 2014-01-31
• Last Update Posted: 2014-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Valsava	Valsava	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.

Primary Outcome Measures

Name	Time	Method
Number of successfully identified reflux with different method of Valsava technic	20 minutes	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.

Secondary Outcome Measures

Name	Time	Method
The timing of identified venous reflux demonstrated in the duplex scan of conventional Valsava and balloon assisted Valsava	20 minutes	The time of identified venous reflux demonstrated in the duplex scan of conventional Valsava and balloon assisted Valsava was compared
The total timing for duplex scan examination in conventional Valsava and balloon assisted Valsava	20 minutes	The total timing for duplex scan examination in conventional Valsava and balloon assisted Valsava was compared
The timing for the instruction of conventional Valsava and balloon assisted Valsava	20 minutes	The time for training patients to performed conventional Valsava and balloon assisted Valsava before duplex examination was compared