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

Varicose Veins Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02051439
• Other study ID #: SIRIRAJ11SU00030/028/11
• Status: Completed
• Phase: N/A
• First received: January 27, 2014
• Last updated: January 29, 2014
• Start date: January 2012
• Est. completion date: May 2012

Study information

• Verified date: January 2014
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Varicose Veins
• Venous Insufficiency

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No