Time Needed to Achieve a Successful Cannulation of the Femoral Artery in Pediatric Cardiac SurgeryNCT02183857
Ultrasound-Guided vs Landmark Technique for Femoral Arterial Cannulation in Pediatric Cardiac Surgery
A study testing Ultrasound and Landmark in people with Time Needed to Achieve a Successful Cannulation of the Femoral Artery in Pediatric Cardiac Surgery, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
The use of ultrasound guidance by senior residents learning the technique of femoral artery catheterization is superior to the landmark technique. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Time Needed to Achieve a Successful Cannulation of the Femoral Artery in Pediatric Cardiac Surgery
- What is being tested?
- Ultrasound and Landmark
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteLebanon
- Study dates
- Jul 2014to Jan 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 Up to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants and children under 12 years of age.
- American Society of Anesthesiologist Physical Status (ASA) III or IV.
- Patients with congenital heart disease undergoing cardiac surgery who do not have existing arterial line access.
- Parents/guardians/patients willing to sign consent.
Who cannot join
- Hematoma or infections at the potential site of insertion.
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
- Need for emergency surgery.
- Hemodynamic instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Femoral Arterial Cannulation Performed by Residents: A Comparison Between Ultrasound-Guided and Landmark Technique in Infants and Children Undergoing Cardiac Surgery
The use of ultrasound guidance by senior residents learning the technique of femoral artery catheterization is superior to the landmark technique.
Read the detailed description
The insertion of percutaneous femoral catheter is the method of choice for arterial monitoring in pediatric patients undergoing cardiac surgery at American University of Beirut Medical Center. It is easier to access since it is a bigger vessel and matches better the aortic pressure immediately post initiation of bypass than the radial artery. Utilizing ultrasound in radial artery cannulation has been well described (1). A meta-analysis of 4 trials showed that, ultrasound guidance for radial artery catheterization improved first-pass success rate compared to the palpation method (2). Two of these trials were for pediatric patients where in one study ultrasound-guided radial arterial cannulation in 30 small children improved success rate with fewer attempts required with the ultrasound technique than with the traditional technique (3). However, in another study of 152 children under 12 years of age requiring radial artery cannulation, there were no statistically significant differences between the groups in time to successful cannulation, total number of attempts, number of successful cannulations during the first attempt, or in the number of cannulae used for catheterization (4). No previous study compared the use of ultrasound guidance vs landmark for femoral artery cannulation in the pediatric age group in particular for the teaching of anesthesia residents.
The hypothesis is that the use of ultrasound guidance by senior residents learning the technique of femoral artery catheterization is superior to the landmark technique.
The investigators will design a prospective randomized trial to compare the use of ultrasound guidance versus landmark technique in 110 children undergoing cardiac surgery. The inclusion criteria are ASA III or IV children under 12 years of age. Exclusion criteria are hematoma or infections at the potential site of insertion, need for emergency surgery, and hemodynamic instability.
The risks to subjects include no more than the usual risks of arterial cannulation (infection and hematoma formation). Adverse events will be monitored, reported and treated appropriately.
Privacy and confidentiality will be respected. Data will be kept under lock with the primary investigator.
- Conditions
- Time Needed to Achieve a Successful Cannulation of the Femoral Artery in Pediatric Cardiac Surgery
- Being tested
- Ultrasound, Landmark
- Keywords
- children, congenital heart disease
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Also called SonoSite 180 PLUS
LandmarkOther
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Other | Patients in group Ultrasound will have their femoral arterial lines inserted under the guidance of US. The Ultrasound equipment used is a SonoSite 180 PLUS with an L25/10- to 5-MHz linear array transducer (SonoSite, Inc., Bothell, WA) Receives: Device: Ultrasound |
| Landmark | Other | No Device is used. Patients in group Landmark will have their femoral line inserted using the blinded, external landmark-guided technique. After localization of the femoral artery by identifying the pulse in the femoral triangle immediately distal to the inguinal ligament. Receives: Other: Landmark |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time needed to achieve a successful cannulation of the femoral artery.
Measured: The time to successful cannula insertion will be calculated from the time of skin penetration until proper placement of the catheter is confirmed by an arterial waveform seen on the monitor after connecting the catheter to a transducer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Time Needed to Achieve a Successful Cannulation of the Femoral Artery in Pediatric Cardiac SurgeryStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar Sayyid, American University of Beirut Medical Center
- Investigators
- Sahar M Siddik-Sayyid, MD, Principal investigator, AUBMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02183857
- Sponsor's protocol ID
- ANES.SS.12
- Status last verified
- Jan 2017
- First submitted
- 3 Jul 2014
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Arterial Cannulation Performed by Residents: A Comparison Between Ultrasound-Guided and Landmark Technique in Infants and Children Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02183857
- Acronym / sponsor ID
- ANES.SS.12
- Conditions
- Time Needed to Achieve a Successful Cannulation of the Femoral Artery in Pediatric Cardiac Surgery
- Keywords
- children, congenital heart disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 8 Jul 2014 (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 use of ultrasound guidance by senior residents learning the technique of femoral artery catheterization is superior to the landmark technique.
Detailed description
The insertion of percutaneous femoral catheter is the method of choice for arterial monitoring in pediatric patients undergoing cardiac surgery at American University of Beirut Medical Center. It is easier to access since it is a bigger vessel and matches better the aortic pressure immediately post initiation of bypass than the radial artery. Utilizing ultrasound in radial artery cannulation has been well described (1). A meta-analysis of 4 trials showed that, ultrasound guidance for radial artery catheterization improved first-pass success rate compared to the palpation method (2). Two of these trials were for pediatric patients where in one study ultrasound-guided radial arterial cannulation in 30 small children improved success rate with fewer attempts required with the ultrasound technique than with the traditional technique (3). However, in another study of 152 children under 12 years of age requiring radial artery cannulation, there were no statistically significant differences between the groups in time to successful cannulation, total number of attempts, number of successful cannulations during the first attempt, or in the number of cannulae used for catheterization (4). No previous study compared the use of ultrasound guidance vs landmark for femoral artery cannulation in the pediatric age group in particular for the teaching of anesthesia residents.
The hypothesis is that the use of ultrasound guidance by senior residents learning the technique of femoral artery catheterization is superior to the landmark technique.
The investigators will design a prospective randomized trial to compare the use of ultrasound guidance versus landmark technique in 110 children undergoing cardiac surgery. The inclusion criteria are ASA III or IV children under 12 years of age. Exclusion criteria are hematoma or infections at the potential site of insertion, need for emergency surgery, and hemodynamic instability.
The risks to subjects include no more than the usual risks of arterial cannulation (infection and hematoma formation). Adverse events will be monitored, reported and treated appropriately.
Privacy and confidentiality will be respected. Data will be kept under lock with the primary investigator.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Other | Device: UltrasoundPatients in group Ultrasound will have their femoral arterial lines inserted under the guidance of US. The Ultrasound equipment used is a SonoSite 180 PLUS with an L25/10- to 5-MHz linear array transducer (SonoSite, Inc., Bothell, WA) |
| Landmark | Other | Other: LandmarkNo Device is used. Patients in group Landmark will have their femoral line inserted using the blinded, external landmark-guided technique. After localization of the femoral artery by identifying the pulse in the femoral triangle immediately distal to the inguinal ligament. |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants and children under 12 years of age.
- American Society of Anesthesiologist Physical Status (ASA) III or IV.
- Patients with congenital heart disease undergoing cardiac surgery who do not have existing arterial line access.
- Parents/guardians/patients willing to sign consent.
Key exclusion criteria (4 listed)
- Hematoma or infections at the potential site of insertion.
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
- Need for emergency surgery.
- Hemodynamic instability
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 |
|---|---|---|
| UltrasoundAlso: SonoSite 180 PLUS | Device | Ultrasound |
| Landmark | Other | Landmark |
Primary outcome
the time needed to achieve a successful cannulation of the femoral artery.
Time frame: The time to successful cannula insertion will be calculated from the time of skin penetration until proper placement of the catheter is confirmed by an arterial waveform seen on the monitor after connecting the catheter to a transducer
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 26 Jan 2017.
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.
Sahar M Siddik-Sayyid, MD principal investigator
AUBMC
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 Landmark in people with Time Needed to Achieve a Successful Cannulation of the Femoral Artery in Pediatric Cardiac Surgery, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 4 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 26 Jan 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 Lebanon. 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?
the time needed to achieve a successful cannulation of the femoral artery. (time frame: The time to successful cannula insertion will be calculated from the time of skin penetration until proper placement of the catheter is confirmed by an arterial waveform seen on the monitor after connecting the catheter to a transducer). 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 26 Jan 2017.