Acute Respiratory FailureCCURDSNCT02825615
Better Arterial Cannulation Technique With Different Hemodynamics
A study testing Radial artery cannulation in people with Acute Respiratory Failure and Shock, run by Sultan Qaboos University.
Trial summary
Purpose Two techniques of radial artery cannulation, ultrasound guided (USG) and conventional method (CM) were compared to find the better technique in general and in different hemodynamic subsets of patients. Method This is a prospective randomized, single center study of 100 patients. Read more about this study
- Who is it for?
- Ages 13 to 90 years
- Conditions the study is for
- Acute Respiratory Failure, Shock
- What is being tested?
- Radial artery cannulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to May 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 13 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All adult Patients worthy of radial artery cannulation, who consented
Who cannot join
- No consent
About this study
Official title: Comparison of Conventional and Ultrasound Guided Techniques of Radial Artery Cannulation in Different Hemodynamic Subsets: a Randomized Controlled Study
Purpose Two techniques of radial artery cannulation, ultrasound guided (USG) and conventional method (CM) were compared to find the better technique in general and in different hemodynamic subsets of patients.
Method This is a prospective randomized, single center study of 100 patients. The details of the primary cannulation technique, number of attempts, time taken, failure and cross-over technique were recorded for three different hemodynamic subsets with Systolic blood pressure <80 mm hg, 80-100 mm hg and > 100 mm hg.
- Conditions
- Acute Respiratory Failure, Shock
- Being tested
- Radial artery cannulation
- Keywords
- radial artery cannulation, ultrasound guided, first success rate, systolic blood pressure, shock
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial artery cannulationProcedure or surgery
Radial artery cannulation done with conventional and ultrasound guidance in two respective groups of patients and their first pass success and ultimate success rates compared in different hemodynamic subsets of the patients.
| Study group | Role | What they receive |
|---|---|---|
| Conventional method (CM) | Active comparator | Radial artery cannulation has been done using the conventional method. Cannulation failure with this technique were tried with USG technique secondarily. Receives: Procedure: Radial artery cannulation |
| Ultrasound guided method (USG) | Experimental | Radial artery cannulation is done with ultrasound guidance for this group of patients. Cannulation failure with this technique were tried with Conventional technique secondarily. Receives: Procedure: Radial artery cannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
First pass success rate
First pass success rate depicted the better method of cannulation of radial artery
Measured: 1 year
Final/ultimate success rate of an intervention
If the primary technique failed then the cannulation was done with the secondary technique and hence the final success rate was calculated for each of the techniques: conventional and ultrasound guided.
Measured: 1 year
Secondary outcomes (2)
Time taken for the respective technique
Time taken for each technique was calculated from start of needle insertion till the cannula was completely inserted. The time was compared between the two arms
Measured: 1 year
Attempts of cannulation
Number of attempts made by a technique was recorded and compared
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 posted7 Jul 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionMay 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 Acute Respiratory FailureStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Qaboos University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825615
- Sponsor's protocol ID
- MREC#644
- Acronym
- CCURDS
- Status last verified
- Jul 2016
- First submitted
- 3 Jul 2016
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conventional and Ultrasound Guided Techniques of Radial Artery Cannulation in Different Hemodynamic Subsets: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02825615
- Acronym / sponsor ID
- CCURDS / MREC#644
- Conditions
- Acute Respiratory Failure, Shock
- Keywords
- radial artery cannulation, ultrasound guided, first success rate, systolic blood pressure, shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sultan Qaboos UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 7 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.
Purpose Two techniques of radial artery cannulation, ultrasound guided (USG) and conventional method (CM) were compared to find the better technique in general and in different hemodynamic subsets of patients.
Method This is a prospective randomized, single center study of 100 patients. The details of the primary cannulation technique, number of attempts, time taken, failure and cross-over technique were recorded for three different hemodynamic subsets with Systolic blood pressure <80 mm hg, 80-100 mm hg and > 100 mm hg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional method (CM) | Active comparator | Procedure: Radial artery cannulationRadial artery cannulation has been done using the conventional method. Cannulation failure with this technique were tried with USG technique secondarily. |
| Ultrasound guided method (USG) | Experimental | Procedure: Radial artery cannulationRadial artery cannulation is done with ultrasound guidance for this group of patients. Cannulation failure with this technique were tried with Conventional technique secondarily. |
Who may qualify
- Ages
- 13 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All adult Patients worthy of radial artery cannulation, who consented
Key exclusion criteria (1 listed)
- No consent
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 |
|---|---|---|
| Radial artery cannulationRadial artery cannulation done with conventional and ultrasound guidance in two respective groups of patients and their first pass success and ultimate success rates compared in different hemodynamic subsets of the patients. | Procedure or surgery | Conventional method (CM), Ultrasound guided method (USG) |
Primary outcome
First pass success rate
Time frame: 1 year
First pass success rate depicted the better method of cannulation of radial artery
Final/ultimate success rate of an intervention
Time frame: 1 year
If the primary technique failed then the cannulation was done with the secondary technique and hence the final success rate was calculated for each of the techniques: conventional and ultrasound guided.
2 secondary outcomes
Time taken for the respective technique
Time frame: 1 year
Attempts of cannulation
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 11 Jul 2016.
- 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.
- Individual participant dataSharing planned: No
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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?
A study testing Radial artery cannulation in people with Acute Respiratory Failure and Shock, run by Sultan Qaboos 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 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 Jul 2016. 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?
First pass success rate (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT02825615, 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 Jul 2016.