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

the purpose of this study is to evaluate the cryotherapy effect by vapocoolant spray to reducing pain during puncture for artérial blood gas

Study Overview

• Status: Completed
• Conditions: Cryotherapy Effect
• Intervention / Treatment: Device: Cryotherapy

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: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Belfort, France, 90015
    • Hôpital Nord Franche-Comté
  • Le Chesnay, France, 78150
    • CH Versailles
  • Paris, France, 75015
    • Hôpital Européen Georges Pompidou
  • Paris, France, 75010
    • CHU Saint Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

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	Device: Cryotherapy; 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	Device: Cryotherapy; 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	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

Collaborators and Investigators

• Sponsor: Versailles Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2020
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: May 27, 2019
• First Submitted That Met QC Criteria: June 1, 2019
• First Posted (Actual): June 4, 2019

Study Record Updates

• Last Update Posted (Actual): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: intensive care unit; cryotherapy; arterial puncture; vapocoolant spray
• 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)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No