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Evaluation of Efficacy of Cryotherapy for Skin Anesthesia During Arterial Puncture (SNOW)

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ClinicalTrials.gov Identifier: NCT03973385
Recruitment Status : Not yet recruiting
First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Jacq Gwenaelle, 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

Condition or disease Intervention/treatment Phase
Cryotherapy Effect Device: Cryotherapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Efficacy of Cryotherapy for Skin Anesthesia During Arterial Puncture for Blood Gas in Critically Ill Patients. SNOW Study
Estimated Study Start Date : July 30, 2019
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2022

Arm Intervention/treatment
Experimental: cryotherapy group
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
Device: Cryotherapy
patients recieving cryotherapy for skin anesthesia for artérial blood gas

Placebo Comparator: control group
water spray is applied on skin for 4 to 10 seconds to centimeters distance with sweeping action before ABG
Device: Cryotherapy
patients recieving cryotherapy for skin anesthesia for artérial blood gas




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Ease to performing Arterial Blood Gas (ABG) sampling [ Time Frame: 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.

  2. Influence of the experience of caregiver [ Time Frame: immediately after puncture ]

    Influence of expérience of caregiver according to number of year of intentive care exercice on the intensity of the pain(1), ease to performing ABG sampling (2) and will be evaluated in each two groups (control group and treatement group) by ;

    1) the pain score will be measured by the patient with the visual analogue scale (VAS), expressed in millimeters from 0 to 100, 2. 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


  3. Influence of concomittent sedation [ Time Frame: immediately after puncture ]

    Influence of concomittent sedation on the intensity of the pain(1), ease to performing ABG sampling (2) and will evaluated in each two groups (control group and treatement group)

    1) the pain score will be measured by the patient with the visual analogue scale (VAS), expressed in millimeters from 0 to 100, 2. 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


  4. influence of type of sample [ Time Frame: immediately after puncture ]

    The influence of the type of sample taken - according to on whether it is an isolated ABG or multiple samples of arterial origin (number of tubes collected) -on the intensity of the pain(1), ease to performing ABG sampling (2) and will be evaluated in each two groups (control group and treatement group)

    1) the pain score will be measured by the patient with the visual analogue scale (VAS), expressed in millimeters from 0 to 100, 2. 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




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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03973385


Contacts
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Contact: GWENAELLE JACQ, RN 139638356 gjacq@ch-versailles.fr

Locations
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France
Hopital Nord Franche-Comte Not yet recruiting
Belfort, France, 90015
Contact: Chauvin Valérie, RN    03.84.98.22.03    valerie.chauvin74@orange.fr   
CHU Saint LOUIS Not yet recruiting
Paris, France, 75010
Contact: Souppart Virginie, RN    01.42.49.94.24    virginie.souppart@aphp.fr   
Hopital Européèn Georges Pompidou Not yet recruiting
Paris, France, 75015
Contact: Jacques Audrey, RN    01.56.09.25.64    aud.jacques@yahoo.fr   
Sponsors and Collaborators
Versailles Hospital
Investigators
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Principal Investigator: Gwenaëlle Jacq, RN CH Versailles

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Responsible Party: Jacq Gwenaelle, Investigator coordinator, Versailles Hospital
ClinicalTrials.gov Identifier: NCT03973385     History of Changes
Other Study ID Numbers: P17/04_SNOW
2018-A00702-53 ( Other Identifier: Registry ID: ID RCB )
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jacq Gwenaelle, Versailles Hospital:
cryotherapy
vapocoolant spray
arterial puncture
intensive care unit

Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs