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

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.

Study Overview

• Status: Completed
• Conditions: Varicose Veins; Venous Insufficiency
• Intervention / Treatment: Procedure: Valsava

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Procedure: Valsava; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mahidol University

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: January 27, 2014
• First Submitted That Met QC Criteria: January 29, 2014
• First Posted (Estimate): January 31, 2014

Study Record Updates

• Last Update Posted (Estimate): January 31, 2014
• Last Update Submitted That Met QC Criteria: January 29, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Doppler; Varicose Veins; Venous Insufficiency; Duplex; Valsava
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency; Varicose Veins
• Other Study ID Numbers: SIRIRAJ11SU00030/028/11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No