ObeseNCT03995264
Ultrasound vs Palpation for Radial Artery Cannulation
A study testing Ultrasound -guided cannulation and Palpation -guided cannulation in people with Obese, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
The primary purpose of this study is to compare the palpation technique with ultrasound guidance for radial artery cannulation for bariatic surgery. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Obese
- What is being tested?
- Ultrasound -guided cannulation and Palpation -guided cannulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2019to 7 Jan 2022
- Phase
- Interventional
- 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists 1, 2, 3 BMI ≥ 30 bariatic surgery
Who cannot join
- refusal infection or surgery history in wrist
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Suwon, Seoul
About this study
Official title: Ultrasound vs Palpation for Radial Artery Cannulation in Patients Undergoing Bariatic Surgery
The primary purpose of this study is to compare the palpation technique with ultrasound guidance for radial artery cannulation for bariatic surgery.
- Conditions
- Obese
- Being tested
- Ultrasound -guided cannulation, Palpation -guided cannulation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound -guided cannulationProcedure or surgery
radial artery cannulation using the ultrasound
Palpation -guided cannulationProcedure or surgery
radial artery cannulation using the palpation
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound group | Experimental | Ultrasound-guided radial artery cannulation Receives: Procedure: Ultrasound -guided cannulation |
| Palpation group | Placebo comparator | Radial artery cannulation with palpation technique Receives: Procedure: Palpation -guided cannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
Success rate at first attempt for radial artery cannulation
Measured: at first attempt, as average 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start1 Aug 2019
- Primary completion7 Jan 2022
- Study completion7 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObeseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Eun Kim, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995264
- Sponsor's protocol ID
- AJIRB-MED-THE-19-148
- Status last verified
- Jan 2022
- First submitted
- 20 Jun 2019
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.
PubMed 34637140
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound vs Palpation for Radial Artery Cannulation in Patients Undergoing Bariatic Surgery
- ClinicalTrials.gov ID
- NCT03995264
- Acronym / sponsor ID
- AJIRB-MED-THE-19-148
- Conditions
- Obese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 7 Jan 2022 (actual)
- Study completion
- 7 Jan 2022 (actual)
- First posted
- 24 Jun 2019 (actual)
- 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 primary purpose of this study is to compare the palpation technique with ultrasound guidance for radial artery cannulation for bariatic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound group | Experimental | Procedure: Ultrasound -guided cannulationUltrasound-guided radial artery cannulation |
| Palpation group | Placebo comparator | Procedure: Palpation -guided cannulationRadial artery cannulation with palpation technique |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists 1, 2, 3 BMI ≥ 30 bariatic surgery
Key exclusion criteria (1 listed)
- refusal infection or surgery history in wrist
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 |
|---|---|---|
| Ultrasound -guided cannulationradial artery cannulation using the ultrasound | Procedure or surgery | Ultrasound group |
| Palpation -guided cannulationradial artery cannulation using the palpation | Procedure or surgery | Palpation group |
Primary outcome
Success rate
Time frame: at first attempt, as average 5 min
Success rate at first attempt for radial artery cannulation
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 11 Jan 2022.
- Derived from this study: PubMed 34637140Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.
Related trials for Obese
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound -guided cannulation and Palpation -guided cannulation in people with Obese, run by Ajou University School of Medicine at 1 site in South Korea.
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 1 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 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Success rate (time frame: at first attempt, as average 5 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03995264, which also lists 1 linked publication.
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 11 Jan 2022.