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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01789801 |
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Date of registration:
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09/02/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Randomized Study Evaluating the Role of Ultra-sound Guidance When Drawing Radial Arterial Blood Samples
ECHO-PARDIF |
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Scientific title:
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A Randomized Study Evaluating the Role of Ultra-sound Guidance When Drawing Radial Arterial Blood Samples |
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Date of first enrolment:
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February 21, 2014 |
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Target sample size:
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74 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01789801 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Romain Genre-Grandpierre, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Hospitalier Universitaire de Nîmes |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient's health status necessitates an arterial blood sample AND his/her radial
arteries are deemed unpalpable OR two previous attempts at radial arterial puncture by
a nurse resulted in failure
Exclusion Criteria:
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, or any kind of guardianship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant, parturient, or breastfeeding
- Arterial puncture is required on femoral, humeral or axillary arteries
- The patient is in cardiac arrest
- The patient has known circulatory problems, ischemia, local infection
- The patient has a severe bleeding or hemostasis disorder (hemophilia,
hypoprothrombinemia, platelets <50,000)
- The patient is an upper limb amputee, or his/her arm is in a cast
- The patient has known allergies to methyl or propylbenzoate, propylene glycol or
chlorexhidine gluconate
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Radial Artery
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Ultrasonography
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Intervention(s)
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Procedure: RAP palpation only
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Procedure: RAP with ultrasound guidance
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Primary Outcome(s)
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Only one attempt at arterial puncture was necessary (yes/no)
[Time Frame: Day 0 - end of procedure]
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Secondary Outcome(s)
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Patient pain evaluation
[Time Frame: Day 0 - end of procedure]
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Operator satisfaction
[Time Frame: Day 0 - end of procedure]
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Was additional assistance necessary? yes/no
[Time Frame: Day 0 - end of procedure]
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The number of catheters used
[Time Frame: Day 0 - end of procedure]
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Patient satisfaction
[Time Frame: Day 0 - end of procedure]
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Presence/absence of complications
[Time Frame: Day 0 - end of procedure]
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Length of time necessary for the procedure
[Time Frame: Day 0 - end of procedure]
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Number of skin punctures
[Time Frame: Day 0 - end of procedure]
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Secondary ID(s)
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LOCAL/2012/RGG-01
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2012-A01525-38
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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