Clinical trial NCT01789801: A Randomized Study Evaluating the Role of Ultra-sound Guidance When Drawing Radial Arterial Blood Samples
Official title: A Randomized Study Evaluating the Role of Ultra-sound Guidance When Drawing Radial Arterial Blood Samples
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radial Artery
Ultrasonography
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2013-02-12
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: test

Eligibility criteria: 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

Primary outcomes:
measure: Only one attempt at arterial puncture was necessary (yes/no)
timeFrame: Day 0 - end of procedure
Secondary outcomes:
measure: Number of skin punctures
timeFrame: Day 0 - end of procedure
measure: Length of time necessary for the procedure
timeFrame: Day 0 - end of procedure
measure: Presence/absence of complications
timeFrame: Day 0 - end of procedure
measure: Patient satisfaction
timeFrame: Day 0 - end of procedure
measure: Operator satisfaction
timeFrame: Day 0 - end of procedure
measure: Patient pain evaluation
timeFrame: Day 0 - end of procedure
measure: The number of catheters used
timeFrame: Day 0 - end of procedure
measure: Was additional assistance necessary? yes/no
timeFrame: Day 0 - end of procedure
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
state: Gard
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Romain Genre-Grandpierre, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.