Evaluation of Efficacy of Cryotherapy for Skin Anesthesia During Arterial Puncture for Blood Gas in Critically Ill Patients. SNOW Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- Pain during arterial puncture
研究概览
简要总结
the purpose of this study is to evaluate the cryotherapy effect by vapocoolant spray to reducing pain during puncture for artérial blood gas
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •legal guardianship
研究组 & 干预措施
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
干预措施: Cryotherapy (Device)
control group
water spray is applied on skin for 4 to 10 seconds to centimeters distance with sweeping action before ABG
干预措施: Cryotherapy (Device)
结局指标
主要结局
Pain during arterial puncture
时间窗: 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)
次要结局
- Ease to performing Arterial Blood Gas (ABG) sampling(immediately after puncture)
研究者
Jacq Gwenaelle
Investigator coordinator
Versailles Hospital