Evaluation of Efficacy of Cryotherapy for Skin Anesthesia During Arterial Puncture

Study Overview
=================
Brief Summary
-----------------
the purpose of this study is to evaluate the cryotherapy effect by vapocoolant spray to reducing pain during puncture for artérial blood gas

Detailed Description
-----------------
Blood gas analysis by arterial puncture is the Gold Standard in the assessment of a patient's acidbase status and oxygenation. This procedure, which can be repeated depending on the clinical condition of patient, is however associated with a potentially painful experience for patients. The known anesthetic properties of cold can be an interesting alternative to evaluate in the reduction of pain induced during arterial puncture for gas analysis in critically il patients.

Official Title
-----------------
Evaluation of Efficacy of Cryotherapy for Skin Anesthesia During Arterial Puncture for Blood Gas in Critically Ill Patients. SNOW Study

Conditions
-----------------
Cryotherapy Effect

Intervention / Treatment
-----------------
* Device: Cryotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients (age≥18 years) hospitalized in Intensive Care Unit Patient requiering arteriale puncture for ABG A négative score of CAM ICU scale Patient with a score to visual analog scale < or equal 30mm Securité sociale affiliated consentement Exclusion Criteria: patient undergoing mechanical ventilation patient with arterial catheter patient with arterio veinius fistul patient receiving topical anesthesic at least 2 h before the puncture patient with cutaneous lesion (zone of puncture) Raynaud Syndrom cold sensibility Allen test negative pregnant legal guardianship

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cryotherapy group<br>cryotherapy by vapocoolant spray is applied on skin for 4 to 10 seconds ( or up to skin whitening) to 15 centimeters distance with sweeping action before ABG | Device: Cryotherapy<br>* patients recieving cryotherapy for skin anesthesia for artérial blood gas<br>|
| Placebo Comparator: control group<br>water spray is applied on skin for 4 to 10 seconds to centimeters distance with sweeping action before ABG | Device: Cryotherapy<br>* patients recieving cryotherapy for skin anesthesia for artérial blood gas<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during arterial puncture | Pain will be assessed with the visual analog scale (numeric value go 0 to 100 millimeters and representing intensity of pain from no pain to worst pain imaginable(1) | immediately after puncture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease to performing Arterial Blood Gas (ABG) sampling | Ease to performing ABG sampling will be evaluated by i)the number of punctures necessary to obtain a sample of at least 1ml of arterial blood, ii) the delay between the first arterial puncture, and obtaining a sample. | immediately after puncture | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cryotherapy, vapocoolant spray, arterial puncture, intensive care unit