Asymptomatic DiseasesNCT02832310
The Effects of Valsalva Maneuver on Head, Neck and Upper Extremity Arterial Systems
An observational study of Asymptomatic Diseases, run by Tokat Gaziosmanpasa University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Asymptomatic Diseases
- What is being tested?
- valsalva maneuver
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: peroperative patients, healhty volunteers
Who may be able to join
- American Society of Anesthesiologists score of I, II, III
Who cannot join
- Morbid obesity (body mass index over 40)
- Not to participate in the study
- Psychiatric diseases
- Peripheral vascular diseases
About this study
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.
Read the 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.
- Conditions
- Asymptomatic Diseases
- Being tested
- valsalva maneuver
- Keywords
- valsalva
- Medical subject headings
- Asymptomatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valsalva maneuverProcedure or surgery
the effects of valsalva maneuver on arterial pressure
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial flow rate
Measured: 1 year
Secondary outcomes (1)
arterial diameter
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startApr 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fatih altıparmak, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832310
- Sponsor's protocol ID
- 16-KAEK-037
- Status last verified
- Feb 2018
- First submitted
- 30 Mar 2016
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Valsalva Maneuver on Head, Neck and Upper Extremity Arterial Systems
- ClinicalTrials.gov ID
- NCT02832310
- Acronym / sponsor ID
- 16-KAEK-037
- Conditions
- Asymptomatic Diseases
- Keywords
- valsalva
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- peroperative patients, healhty volunteers
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists score of I, II, III
Key exclusion criteria (4 listed)
- Morbid obesity (body mass index over 40)
- Not to participate in the study
- Psychiatric diseases
- Peripheral vascular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| valsalva maneuverthe effects of valsalva maneuver on arterial pressure | Procedure or surgery | – |
Primary outcome
arterial flow rate
Time frame: 1 year
1 secondary outcome
arterial diameter
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
- Individual participant dataSharing planned: No
Related trials for Asymptomatic Diseases
RecruitingPhase 3
Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Not yet recruitingObservational study
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
Recruiting
Assessment of a Portable Digital Device for Quantified Analysis of Markerless Walking in Volunteers With Neuromuscular Diseases or Asymptomatic Volunteers
Spinal Muscular Atrophy (SMA), Charcot-Marie-Tooth
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Active, not recruitingObservational study
Analysis of Coronavirus Disease 19 (COVID-19) Convalescent Plasma
Asymptomatic COVID-19 Infection Laboratory-Confirmed, Symptomatic COVID-19 Infection Laboratory-Confirmed
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Asymptomatic Diseases, run by Tokat Gaziosmanpasa University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
arterial flow rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2018.