Evaluation of Efficacy of Cryotherapy for Skin Anesthesia During Arterial Puncture
SNOW
2 other identifiers
interventional
200
1 country
4
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2020
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2019
CompletedFirst Posted
Study publicly available on registry
June 4, 2019
CompletedStudy Start
First participant enrolled
November 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedJuly 25, 2022
July 1, 2022
1.1 years
May 27, 2019
July 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Ease to performing Arterial Blood Gas (ABG) sampling
immediately after puncture
Study Arms (2)
cryotherapy group
EXPERIMENTALcryotherapy 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
control group
PLACEBO COMPARATORwater spray is applied on skin for 4 to 10 seconds to centimeters distance with sweeping action before ABG
Interventions
patients recieving cryotherapy for skin anesthesia for artérial blood gas
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Hopital Nord Franche-Comte
Belfort, 90015, France
Ch Versailles
Le Chesnay, 78150, France
CHU Saint LOUIS
Paris, 75010, France
Hopital Européèn Georges Pompidou
Paris, 75015, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gwenaëlle Jacq, RN
CH Versailles
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigator coordinator
Study Record Dates
First Submitted
May 27, 2019
First Posted
June 4, 2019
Study Start
November 5, 2020
Primary Completion
November 30, 2021
Study Completion
June 30, 2022
Last Updated
July 25, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share