Arterial CannulationNCT01742416
Ultrasound Assisted Arterial Cannulation in Small Children
A study testing Ultrasound and Palpation Method in people with Arterial Cannulation, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Arterial cannulation is a commonly performed invasive procedure in the operation room, the emergency department, and in the intensive care unit. The indications include the need for continuous blood-pressure monitoring, frequent arterial blood-gas analysis, and repeated blood sampling for laboratory evaluation. Read more about this study
- Who is it for?
- Ages 1 day to 24 months
- Conditions the study is for
- Arterial Cannulation
- What is being tested?
- Ultrasound and Palpation Method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2012to Jun 2013
- 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 day to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 24 months or younger
- Children undergoing elective surgical procedures where arterial cannulation is planned by the attending anaesthetist. These procedures include cardiac surgery, craniotomies, cranial vault surgery, and some abdominal procedures.
Who cannot join
- Refusal of consent from the parents
- Refusal of participation from the anaesthetist
- Children with anticipated circulatory instability after anaesthesia induction
- Pulmonary hypertension defined as an estimated pulmonary arterial pressure which is greater than or equal to 66% of systemic blood pressure
- Children with severe heart failure (right and/or left)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Assisted Arterial Cannulation in Small Children - To See or Not to See?
Arterial cannulation is a commonly performed invasive procedure in the operation room, the emergency department, and in the intensive care unit. The indications include the need for continuous blood-pressure monitoring, frequent arterial blood-gas analysis, and repeated blood sampling for laboratory evaluation. This procedure can be challenging even in the best of hands. Traditionally, the artery is located by feeling the pulse of the patient. The pulse may, however be weak or absent in patients with hypotension, edema, obesity or local thrombosis due to previous arterial cannulation in the same location. Furthermore, the catheter may not be passed successfully into the artery, despite apparent good blood return on initial puncture, or hematoma and spasms of the artery may develop after failed attempts, thus making further attempts even more difficult. While ultrasound (US) is being used with increasing frequency for central venous access, fewer clinicians are familiar with US-guided arterial catheterization. The aim of this study is to investigate if ultrasound facilitates arterial cannulation in children ≤24 months compared with the palpation method and to investigate the potential extra costs/savings of introducing the method. This study hypothesizes that the ultrasound method will facilitate arterial cannulation in small children compared with the palpation method.
- Conditions
- Arterial Cannulation
- Being tested
- Ultrasound, Palpation Method
- Keywords
- Arterial Cannulation, Ultrasound, Palpation Method, Pediatrics, Cardiac Surgery, Craniotomies, Cranial Vault Surgery, Abdominal Procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundProcedure or surgery
Arterial cannulation facilitated by ultrasound.
Palpation MethodProcedure or surgery
Arterial cannulation by palpation method.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Experimental | Not described Receives: Procedure: Ultrasound |
| Palpation Method | Active comparator | Not described Receives: Procedure: Palpation Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Attempts
To measure the number of attempts to cannulate the artery per participant.
Measured: Change from baseline to successful cannulation (estimated average of 30 minutes)
Secondary outcomes (5)
Time to Successful Cannulation
To measure the difference between the time when the palpating finger touches the skin (palpation group) or the gel is applied to the skin (US group) at the first intended cannulation site and the time when the arterial cannula is correctly in place.
Measured: Change from baseline to successful cannulation (estimated average of 30 minutes)
Rate of Success of First Attempt
The rate of success of first attempt to cannulate the artery of each participant.
Measured: Change from baseline to success of first attempt, when artery is successfully cannulated on first attempt (estimated average of 30 minutes)
Number of Attempted Sites
To measure the total number of attempted sites.
Measured: Change from baseline to successful cannulation (estimated average of 30 minutes)
Learning Curve
To measure the learning curve for each of the participating anaesthetist.
Measured: At approximately 4 months
Cost of Procedure
To measure the estimated cost of the procedure.
Measured: Duration of the study (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial CannulationStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Taylor, The Hospital for Sick Children
- Investigators
- Katherine Taylor, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742416
- Sponsor's protocol ID
- 1000030723
- Status last verified
- Jul 2019
- First submitted
- 30 Nov 2012
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assisted Arterial Cannulation in Small Children - To See or Not to See?
- ClinicalTrials.gov ID
- NCT01742416
- Acronym / sponsor ID
- 1000030723
- Conditions
- Arterial Cannulation
- Keywords
- Arterial Cannulation, Ultrasound, Palpation Method, Pediatrics, Cardiac Surgery, Craniotomies, Cranial Vault Surgery, Abdominal Procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 5 Dec 2012 (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.
Arterial cannulation is a commonly performed invasive procedure in the operation room, the emergency department, and in the intensive care unit. The indications include the need for continuous blood-pressure monitoring, frequent arterial blood-gas analysis, and repeated blood sampling for laboratory evaluation. This procedure can be challenging even in the best of hands. Traditionally, the artery is located by feeling the pulse of the patient. The pulse may, however be weak or absent in patients with hypotension, edema, obesity or local thrombosis due to previous arterial cannulation in the same location. Furthermore, the catheter may not be passed successfully into the artery, despite apparent good blood return on initial puncture, or hematoma and spasms of the artery may develop after failed attempts, thus making further attempts even more difficult. While ultrasound (US) is being used with increasing frequency for central venous access, fewer clinicians are familiar with US-guided arterial catheterization. The aim of this study is to investigate if ultrasound facilitates arterial cannulation in children ≤24 months compared with the palpation method and to investigate the potential extra costs/savings of introducing the method. This study hypothesizes that the ultrasound method will facilitate arterial cannulation in small children compared with the palpation method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Experimental | Procedure: Ultrasound |
| Palpation Method | Active comparator | Procedure: Palpation Method |
Who may qualify
- Ages
- 1 day to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children 24 months or younger
- Children undergoing elective surgical procedures where arterial cannulation is planned by the attending anaesthetist. These procedures include cardiac surgery, craniotomies, cranial vault surgery, and some abdominal procedures.
Key exclusion criteria (5 listed)
- Refusal of consent from the parents
- Refusal of participation from the anaesthetist
- Children with anticipated circulatory instability after anaesthesia induction
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 |
|---|---|---|
| UltrasoundArterial cannulation facilitated by ultrasound. | Procedure or surgery | Ultrasound |
| Palpation MethodArterial cannulation by palpation method. | Procedure or surgery | Palpation Method |
Primary outcome
Number of Attempts
Time frame: Change from baseline to successful cannulation (estimated average of 30 minutes)
To measure the number of attempts to cannulate the artery per participant.
5 secondary outcomes
Time to Successful Cannulation
Time frame: Change from baseline to successful cannulation (estimated average of 30 minutes)
Rate of Success of First Attempt
Time frame: Change from baseline to success of first attempt, when artery is successfully cannulated on first attempt (estimated average of 30 minutes)
Number of Attempted Sites
Time frame: Change from baseline to successful cannulation (estimated average of 30 minutes)
Learning Curve
Time frame: At approximately 4 months
Cost of Procedure
Time frame: Duration of the study (6 months)
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 5 Jul 2019.
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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.
Katherine Taylor, MD principal investigator
The Hospital for Sick Children
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 Palpation Method in people with Arterial Cannulation, run by The Hospital for Sick Children at 1 site in Canada.
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 2 inclusion and 5 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 5 Jul 2019. 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 Canada. 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?
Number of Attempts (time frame: Change from baseline to successful cannulation (estimated average of 30 minutes)). 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 5 Jul 2019.