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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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