- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03973385
Evaluation of Efficacy of Cryotherapy for Skin Anesthesia During Arterial Puncture (SNOW)
Evaluation of Efficacy of Cryotherapy for Skin Anesthesia During Arterial Puncture for Blood Gas in Critically Ill Patients. SNOW Study
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Belfort, France, 90015
- Hôpital Nord Franche-Comté
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Le Chesnay, France, 78150
- CH Versailles
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Paris, France, 75015
- Hopital Europeen Georges Pompidou
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Paris, France, 75010
- CHU Saint Louis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: cryotherapy group
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
|
patients recieving cryotherapy for skin anesthesia for artérial blood gas
|
Placebo Comparator: control group
water spray is applied on skin for 4 to 10 seconds to centimeters distance with sweeping action before ABG
|
patients recieving cryotherapy for skin anesthesia for artérial blood gas
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain during arterial puncture
Time Frame: immediately after 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
Time Frame: immediately after puncture
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- P17/04_SNOW
- 2018-A00702-53 (Other Identifier: Registry ID: ID RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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