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Ultrasound-Guided vs Landmark Technique for Femoral Arterial Cannulation in Pediatric Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT02183857
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):
Sahar Sayyid, American University of Beirut Medical Center

Brief Summary:
The use of ultrasound guidance by senior residents learning the technique of femoral artery catheterization is superior to the landmark technique.

Condition or disease Intervention/treatment Phase
Time Needed to Achieve a Successful Cannulation of the Femoral Artery in Pediatric Cardiac Surgery Device: Ultrasound Other: Landmark Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Femoral Arterial Cannulation Performed by Residents: A Comparison Between Ultrasound-Guided and Landmark Technique in Infants and Children Undergoing Cardiac Surgery
Study Start Date : July 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Ultrasound
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)
Device: Ultrasound
Other Name: SonoSite 180 PLUS

Landmark
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.
Other: Landmark



Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Infants and children under 12 years of age.
  2. American Society of Anesthesiologist Physical Status (ASA) III or IV.
  3. Patients with congenital heart disease undergoing cardiac surgery who do not have existing arterial line access.
  4. Parents/guardians/patients willing to sign consent.

Exclusion Criteria:

  1. Hematoma or infections at the potential site of insertion.
  2. Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
  3. Need for emergency surgery.
  4. Hemodynamic instability

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02183857


Locations
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Lebanon
American University of Beirut Medical center
Beirut, Lebanon
Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
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Principal Investigator: Sahar M Siddik-Sayyid, MD AUBMC

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Responsible Party: Sahar Sayyid, Professor, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT02183857    
Other Study ID Numbers: ANES.SS.12
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017
Keywords provided by Sahar Sayyid, American University of Beirut Medical Center:
children
congenital heart disease