|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT02183857 |
|
Date of registration:
|
03/07/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Ultrasound-Guided vs Landmark Technique for Femoral Arterial Cannulation in Pediatric Cardiac Surgery
|
|
Scientific title:
|
Femoral Arterial Cannulation Performed by Residents: A Comparison Between Ultrasound-Guided and Landmark Technique in Infants and Children Undergoing Cardiac Surgery |
|
Date of first enrolment:
|
July 2014 |
|
Target sample size:
|
106 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02183857 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Single (Participant).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Lebanon
| | | | | | | |
|
Contacts
|
|
Name:
|
Sahar M Siddik-Sayyid, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
AUBMC |
| | |
|
Key inclusion & exclusion 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
Age minimum:
N/A
Age maximum:
12 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Time Needed to Achieve a Successful Cannulation of the Femoral Artery in Pediatric Cardiac Surgery
|
|
Intervention(s)
|
|
Device: Ultrasound
|
|
Other: Landmark
|
|
Primary Outcome(s)
|
|
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]
|
|
Secondary ID(s)
|
|
ANES.SS.12
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|