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NCT Number: NCT02051439

The Party Balloon Assisted Valsalva 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.

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Key information

Conditions

Varicose Veins Cardiovascular Diseases Vascular Diseases Venous Insufficiency

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Number of successfully identified reflux with different method of Valsava technic

    Time frame: 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 outcomes

  1. The timing for the instruction of conventional Valsava and balloon assisted Valsava

    Time frame: 20 minutes

    The time for training patients to performed conventional Valsava and balloon assisted Valsava before duplex examination was compared

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

    Time frame: 20 minutes

    The time of identified venous reflux demonstrated in the duplex scan of conventional Valsava and balloon assisted Valsava was compared

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

    Time frame: 20 minutes

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

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 31, 2014
Registry last updated
Jan 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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