Evaluation of Efficacy of Cryotherapy for Skin Anesthesia During Arterial Puncture

Cryotherapy Effect Clinical Trial

— SNOW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03973385
• Other study ID #: P17/04_SNOW
• Secondary ID: 2018-A00702-53
• Status: Completed
• Phase: N/A
• Start date: November 5, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2022
• Source: Versailles Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 30, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Cryotherapy Effect

Intervention

Device:
• Cryotherapy
patients recieving cryotherapy for skin anesthesia for artérial blood gas

Locations

Country	Name	City	State
France	Hopital Nord Franche-Comte	Belfort
France	Ch Versailles	Le Chesnay
France	CHU Saint LOUIS	Paris
France	Hopital Européèn Georges Pompidou	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Versailles Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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