Cryotherapy EffectSNOWNCT03973385
Evaluation of Efficacy of Cryotherapy for Skin Anesthesia During Arterial Puncture
A study testing Cryotherapy in people with Cryotherapy Effect, run by Versailles Hospital at 4 sites in France.
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 Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Cryotherapy Effect
- What is being tested?
- Cryotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 4 sitesFrance
- Study dates
- 5 Nov 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- cold sensibility
- Allen test negative
- pregnant
- legal guardianship
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hopital Nord Franche-Comte
Belfort, 90015
Ch Versailles
Le Chesnay, 78150
CHU Saint LOUIS
Paris, 75010
Hopital Européèn Georges Pompidou
Paris, 75015
About this study
Official title: 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
Read the 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.
- Conditions
- Cryotherapy Effect
- Being tested
- Cryotherapy
- Keywords
- cryotherapy, vapocoolant spray, arterial puncture, intensive care unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyDevice
patients recieving cryotherapy for skin anesthesia for artérial blood gas
| Study group | Role | What they receive |
|---|---|---|
| cryotherapy group | Experimental | 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 Receives: Device: Cryotherapy |
| control group | Placebo comparator | water spray is applied on skin for 4 to 10 seconds to centimeters distance with sweeping action before ABG Receives: Device: Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: immediately after puncture
Secondary outcomes (1)
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.
Measured: immediately after puncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start5 Nov 2020
- Primary completion30 Nov 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cryotherapy EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacq Gwenaelle, Versailles Hospital
- Investigators
- Gwenaëlle Jacq, RN, Principal investigator, CH Versailles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973385
- Sponsor's protocol ID
- P17/04_SNOW
- Other IDs
- 2018-A00702-53
- Acronym
- SNOW
- Status last verified
- Jul 2026
- First submitted
- 27 May 2019
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jacq G, Minghetti F, Souppart V, Labreuche J, Aegerter P, Chauvin V, Legriel S. Efficacy of local cryoanalgesia by vapocoolant spray on pain induced by arterial puncture in critically ill patients: A multicentre randomised controlled trial (SNOW study). Aust Crit Care. 2026 Jun;39(3):101581. doi: 10.1016/j.aucc.2026.101581. Epub 2026 Apr 17.
PubMed 41996883
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy of Cryotherapy for Skin Anesthesia During Arterial Puncture for Blood Gas in Critically Ill Patients. SNOW Study
- ClinicalTrials.gov ID
- NCT03973385
- Acronym / sponsor ID
- SNOW / P17/04_SNOW
- Conditions
- Cryotherapy Effect
- Keywords
- cryotherapy, vapocoolant spray, arterial puncture, intensive care unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cryotherapy group | Experimental | Device: Cryotherapycryotherapy 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 comparator | Device: Cryotherapywater spray is applied on skin for 4 to 10 seconds to centimeters distance with sweeping action before ABG |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryotherapypatients recieving cryotherapy for skin anesthesia for artérial blood gas | Device | control group, cryotherapy group |
Primary outcome
Pain during arterial puncture
Time frame: 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)
1 secondary outcome
Ease to performing Arterial Blood Gas (ABG) sampling
Time frame: immediately after puncture
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Results publication: PubMed 41996883Jacq G, Minghetti F, Souppart V, Labreuche J, Aegerter P, Chauvin V, Legriel S. Efficacy of local cryoanalgesia by vapocoolant spray on pain induced by arterial puncture in critically ill patients: A multicentre randomised controlled trial (SNOW study). Aust Crit Care. 2026 Jun;39(3):101581. doi: 10.1016/j.aucc.2026.101581. Epub 2026 Apr 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gwenaëlle Jacq, RN principal investigator
CH Versailles
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy in people with Cryotherapy Effect, run by Versailles Hospital at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during arterial puncture (time frame: immediately after puncture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03973385, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.