Back to resultsThe Party Balloon Assisted Valsalva in Diagnosis of Superficial Venous Valvular Reflux of Lower Limb
Primary Purpose
Varicose Veins, Venous Insufficiency
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Valsava
Sponsored by
About this trial
This is an interventional diagnostic trial for Varicose Veins focused on measuring Varicose Veins, Venous Insufficiency, Doppler, Duplex, Valsava
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Valsava
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02051439
Brief Title
The Party Balloon Assisted Valsalva in Diagnosis of Superficial Venous Valvular Reflux of Lower Limb
Official Title
A Comparison of the Party Balloon Assisted Valsalva With Conventional Valsalva Maneuver in Diagnosis of Superficial Venous Valvular Reflux of Lower Limb
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins, Venous Insufficiency
Keywords
Varicose Veins, Venous Insufficiency, Doppler, Duplex, Valsava
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Valsava
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Valsava
Intervention Description
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 Outcome Measure Information:
Title
Number of successfully identified reflux with different method of Valsava technic
Description
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.
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
The timing for the instruction of conventional Valsava and balloon assisted Valsava
Description
The time for training patients to performed conventional Valsava and balloon assisted Valsava before duplex examination was compared
Time Frame
20 minutes
Title
The timing of identified venous reflux demonstrated in the duplex scan of conventional Valsava and balloon assisted Valsava
Description
The time of identified venous reflux demonstrated in the duplex scan of conventional Valsava and balloon assisted Valsava was compared
Time Frame
20 minutes
Title
The total timing for duplex scan examination in conventional Valsava and balloon assisted Valsava
Description
The total timing for duplex scan examination in conventional Valsava and balloon assisted Valsava was compared
Time Frame
20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
12. IPD Sharing Statement
Learn more about this trial
The Party Balloon Assisted Valsalva in Diagnosis of Superficial Venous Valvular Reflux of Lower Limb
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