Evaluation of Efficacy of Cryotherapy for Skin Anesthesia During Arterial Puncture

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-05

Study Completion Date

2022-06-30

Brief Summary

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

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Detailed Description

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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

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Cryotherapy Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Cryotherapy

Intervention Type DEVICE

patients recieving cryotherapy for skin anesthesia for artérial blood gas

control group

water spray is applied on skin for 4 to 10 seconds to centimeters distance with sweeping action before ABG

Group Type PLACEBO_COMPARATOR

Cryotherapy

Intervention Type DEVICE

patients recieving cryotherapy for skin anesthesia for artérial blood gas

Interventions

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Cryotherapy

patients recieving cryotherapy for skin anesthesia for artérial blood gas

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No