The Effects of Valsalva Maneuver on Head, Neck and Upper... | NCT02832310

Studies
The Effects of Valsalva Maneuver on Head, Neck and Upper Extremity Arterial Systems

NCT02832310

Sponsor

Tokat Gaziosmanpasa University

Status

Completed

Last Update Posted

Feb 6, 2018Actual

Enrollment

70Actual

Phase

Not provided

Conditions

Asymptomatic Diseases

Interventions

valsalva maneuver

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Jul 2016Actual

Completion Date

Jul 2016Actual

First Submitted Date

Mar 30, 2016

First Submission Date that Met QC Criteria

Jul 13, 2016

First Posted Date

Jul 14, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2018

Last Update Posted Date

Feb 6, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to determine the relation between arterial diameter and flow of carotis interna, brachial artery and radial artery before and after valsalva maneuver.

Detailed Description

The aim of this study is to determine the relation between arterial diameter and flow of carotis interna, brachial artery and radial artery before and after valsalva maneuver. A total of 70 patients in preoperative period will enroll in this study. After a deep inspiration, patients will asked to exhale to a valf system with a flow pressure of 20-40 mmHg and duration of 15 seconds. During valsalva maneuver, the diameter and flow rates of carotis interna, brachial artery and radial artery will measure using ultrasound. All data will be recorded.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
valsalva maneuver	Procedure	the effects of valsalva maneuver on arterial pressure

Measure	Description	Time Frame
arterial flow rate		1 year

Measure	Description	Time Frame
arterial diameter		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

American Society of Anesthesiologists score of I, II, III

Exclusion Criteria:

Morbid obesity (body mass index over 40)
Not to participate in the study
Psychiatric diseases
Peripheral vascular diseases

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

peroperative patients, healhty volunteers

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058070	Asymptomatic Diseases

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014636	Valsalva Maneuver

Ancestor Terms

ID	Term
D006334	Heart Function Tests
D003935	Diagnostic Techniques, Cardiovascular
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided