Evaluation of Efficacy of Cryotherapy for Skin Anesthesia During Arterial Puncture

Not Applicable

Completed

• Conditions: Cryotherapy Effect
• Interventions: Device: Cryotherapy

• Registration Number: NCT03973385
• Lead Sponsor: Versailles Hospital

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.

Study Timeline

• Study First Submitted: 2019-05-27
• Study First Submitted QC: 2019-06-01
• Study First Posted: 2019-06-04
• Study Start: 2020-11-05
• Primary Completion: 2021-11-30
• Study Completion: 2022-06-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-22
• Last Update Posted: 2022-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Cryotherapy	water spray is applied on skin for 4 to 10 seconds to centimeters distance with sweeping action before ABG
cryotherapy group	Cryotherapy	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

Primary Outcome Measures

Name	Time	Method
Pain during arterial puncture	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)

Secondary Outcome Measures

Name	Time	Method
Ease to performing Arterial Blood Gas (ABG) sampling	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.

Trial Locations

Locations (4)

Hopital Européèn Georges Pompidou; 🇫🇷 Paris, France

CHU Saint LOUIS; 🇫🇷 Paris, France

Ch Versailles; 🇫🇷 Le Chesnay, France

Hopital Nord Franche-Comte; 🇫🇷 Belfort, France