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

NCT02051439 | Completed

• 1 other identifier: SIRIRAJ11SU00030/028/11
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Varicose Veins; Venous Insufficiency

Keywords

Varicose Veins; Venous Insufficiency; Doppler; Duplex; Valsava

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The timing for the instruction of conventional Valsava and balloon assisted Valsava

  20 minutes

• The timing of identified venous reflux demonstrated in the duplex scan of conventional Valsava and balloon assisted Valsava

  20 minutes

• The total timing for duplex scan examination in conventional Valsava and balloon assisted Valsava

  20 minutes

Study Arms (1)

Valsava

OTHER

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

Interventions

Valsava PROCEDURE

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.

Valsava

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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)

Sponsors & Collaborators

• Mahidol University: lead

MeSH Terms

Conditions

Varicose Veins; Venous Insufficiency

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: January 31, 2014
• Study Start: January 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: January 31, 2014

Record last verified: 2014-01