A Randomized Study Evaluating the Role of Ultra-sound Guidance When Drawing Radial Arterial Blood Samples

Study Overview
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Brief Summary
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Previous studies have demonstrated that an experienced ultrasound operator is able to efficiently perform radial arterial puncture on patients where an initial operator failed to puncture arteries via simple palpation. The objective of this study is to compare difficult-to-puncture patients randomized into two groups: one group where ultrasound is used to aid artery localisation, and one group where only palpation is used.

Detailed Description
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test

Official Title
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A Randomized Study Evaluating the Role of Ultra-sound Guidance When Drawing Radial Arterial Blood Samples

Conditions
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Radial Artery, Ultrasonography

Intervention / Treatment
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* Procedure: RAP palpation only
* Procedure: RAP with ultrasound guidance


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Palpation only<br>Patients randomized to this arm will have radial artery puncture via palpation of arteries. Intervention: RAP palpation only | Procedure: RAP palpation only<br>* Skin disinfection by local antiseptic. Identification of the radial artery by palpation. Insertion of the needle positioned at 70 ° with regard to the artery palpated. Check the rise of arterial blood in the syringe.<br>* Other names: Radial artery puncture via palpation of arteries only;|
| Experimental: Ultrasound guidance<br>Patients randomized to this arm will have radial artery puncture with ultrasound guidance for artery localisation. Intervention: RAP with ultrasound guidance | Procedure: RAP with ultrasound guidance<br>* Skin disinfection by local antiseptic. Application of sterile gel. Identification of the artery via ultrasound vascular probe. Center the artery at the center of the screen. Introduction of the syringe at 70 ° with respect to the probe, in center of visualized zone. Check the rise of arterial blood in the syringe.<br>* Other names: radial artery puncture with ultrasound guidance.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Only one attempt at arterial puncture was necessary (yes/no) |  | Day 0 - end of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of skin punctures |  | Day 0 - end of procedure | 
| Length of time necessary for the procedure |  | Day 0 - end of procedure | 
| Presence/absence of complications | Presence/absence of complications including hematoma, nerve injury, vagal reaction, pseudo-aneurysm. | Day 0 - end of procedure | 
| Patient satisfaction | Patient satisfaction is evaluated using a visual analog scale. | Day 0 - end of procedure | 
| Operator satisfaction | Operator satisfaction is estimated using a visual analog scale. | Day 0 - end of procedure | 
| Patient pain evaluation | Patients are asked to evaluate the experienced pain level using a visual analog scale. | Day 0 - end of procedure | 
| The number of catheters used |  | Day 0 - end of procedure | 
| Was additional assistance necessary? yes/no |  | Day 0 - end of procedure |