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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02051439

Enrollment

Registered

2014-01-31

Start date

2012-01-31

Completion date

2012-05-31

Last updated

2014-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varicose Veins, Venous Insufficiency

Keywords

Varicose Veins, Venous Insufficiency, Doppler, Duplex, Valsava

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.

Interventions

PROCEDUREValsava

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026