Critical IllnessNCT02668471
U/S Guided vs. Traditional Palpation for Radial Artery Cannulation
A study testing Ultrasound and traditional method in people with Critical Illness, run by Ramathibodi Hospital at 1 site in Thailand.
Trial summary
The purpose of this study is to compare the efficacy of ultrasound- guided with the traditional palpation radial artery cannulation in critically ill children. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- Ultrasound and traditional method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2015to 30 Aug 2016
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients who required radial artery cannulation for hemodynamic monitoring or frequent blood samples in intensive care unit
Who cannot join
- Wound at area of cannulation
- Can not palpate or weak radial artery pulse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Compared With Traditional Palpation Radial Artery Cannulation in Critically Ill Children
The purpose of this study is to compare the efficacy of ultrasound- guided with the traditional palpation radial artery cannulation in critically ill children.
Read the detailed description
Arterial catheterization is often performed in critically ill patients for continuous hemodynamic monitoring and blood sampling. However, insertion of radial artery catheter with traditional palpation may be technically challenging, particularly in pediatric patients. There are few published studies on the use of ultrasound guidance for radial-artery catheter placement and mostly they were elective surgery children which received inhalation or deep sedative medication. Recently no setting published in pediatric intensive care unit.
- Conditions
- Critical Illness
- Being tested
- Ultrasound, traditional method
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundProcedure or surgery
ultrasound at radial site and measure the size and depth of radial artery and perform radial artery cannulation
traditional methodProcedure or surgery
Radial artery catheters will be placed by the palpation technique only.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided | Experimental | Radial artery catheters will be placed with the assistance of bedside ultrasound. Receives: Procedure: Ultrasound |
| traditional method | Active comparator | Radial artery catheters will be placed by the palpation technique only. Receives: Procedure: traditional method |
What is being measured
The primary outcome is the main question the study is designed to answer.
first attempt success rate of radial artery catheter insertion
Measured: 5 minute
Secondary outcomes (1)
time to success of radial artery catheter insertion
Measured: 15 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startAug 2015
- Primary completion30 Aug 2016
- Study completion30 Aug 2016
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 Critical IllnessStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nattachai Anantasit, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668471
- Sponsor's protocol ID
- ID-09-58-14
- Status last verified
- Apr 2017
- First submitted
- 22 Jan 2016
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Huang HP, Zhao WJ, Wen F, Li XY. Application of ultrasound-guided radial artery cannulation in paediatric patients: A systematic review and meta-analysis. Aust Crit Care. 2021 Jul;34(4):388-394. doi: 10.1016/j.aucc.2020.09.001. Epub 2020 Oct 21.
PubMed 33097369
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Compared With Traditional Palpation Radial Artery Cannulation in Critically Ill Children
- ClinicalTrials.gov ID
- NCT02668471
- Acronym / sponsor ID
- ID-09-58-14
- Conditions
- Critical Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- 30 Aug 2016 (actual)
- Study completion
- 30 Aug 2016 (actual)
- First posted
- 29 Jan 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 purpose of this study is to compare the efficacy of ultrasound- guided with the traditional palpation radial artery cannulation in critically ill children.
Detailed description
Arterial catheterization is often performed in critically ill patients for continuous hemodynamic monitoring and blood sampling. However, insertion of radial artery catheter with traditional palpation may be technically challenging, particularly in pediatric patients. There are few published studies on the use of ultrasound guidance for radial-artery catheter placement and mostly they were elective surgery children which received inhalation or deep sedative medication. Recently no setting published in pediatric intensive care unit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided | Experimental | Procedure: UltrasoundRadial artery catheters will be placed with the assistance of bedside ultrasound. |
| traditional method | Active comparator | Procedure: traditional methodRadial artery catheters will be placed by the palpation technique only. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pediatric patients who required radial artery cannulation for hemodynamic monitoring or frequent blood samples in intensive care unit
Key exclusion criteria (2 listed)
- Wound at area of cannulation
- Can not palpate or weak radial artery pulse
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 |
|---|---|---|
| Ultrasoundultrasound at radial site and measure the size and depth of radial artery and perform radial artery cannulation | Procedure or surgery | Ultrasound guided |
| traditional methodRadial artery catheters will be placed by the palpation technique only. | Procedure or surgery | traditional method |
Primary outcome
first attempt success rate of radial artery catheter insertion
Time frame: 5 minute
1 secondary outcome
time to success of radial artery catheter insertion
Time frame: 15 minute
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 27 Apr 2017.
- Derived from this study: PubMed 33097369Huang HP, Zhao WJ, Wen F, Li XY. Application of ultrasound-guided radial artery cannulation in paediatric patients: A systematic review and meta-analysis. Aust Crit Care. 2021 Jul;34(4):388-394. doi: 10.1016/j.aucc.2020.09.001. Epub 2020 Oct 21.
- Individual participant dataSharing planned: Undecided
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
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 and traditional method in people with Critical Illness, run by Ramathibodi Hospital at 1 site in Thailand.
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 2 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 27 Apr 2017. 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 Thailand. 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. 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?
first attempt success rate of radial artery catheter insertion (time frame: 5 minute). 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 NCT02668471, 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 27 Apr 2017.