Effect of Tourniquet Abstention on Pain Reduction in Venous Sampling in the Elderly People : Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 5
- 主要终点
- Comparison of the maximum pain associated with venous puncture, in elderly patients with a visible or palpable vein depending on the method of sampling.
研究概览
简要总结
This prospective study evaluates the effect of abstaining from tourniquets on pain reduction during the venous puncture of the elderly people.
详细描述
Almost 3 million people aged 70 and over are hospitalized once or more each year. The implementation of multiple treatments in these fragile patients, often poly-pathological requires a regular biological monitoring. For these patients, samples must be taken on average every two days.
This population often has a fragile venous capital due to reduced skin elasticity, undernutrition more or less associated with dehydration, the use of certain venous-toxic treatments and / or repetition of the gesture taking into account the monitoring biological closely related to long-term therapies.
With the aim of well-treatment and well-being, the reduction of patient pain is one of the major concerns of caregivers and in particular pain induced by treatment.
In children, the practice of harvesting without tourniquet is already frequent (18) and our preliminary study has confirmed us on the tourniquet as one of the acts responsible for the pain that the caregiver can possibly abstain.
No study had been conducted on this subject in the adult population and more particularly the elderly population. This prospective study evaluates the effect of abstaining from tourniquets on pain reduction during the venous puncture of the elderly people.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 75 years and over,
- •Hospitalized in internal medicine or geriatric department,
- •For which the 2 upper limbs are accessible to venous puncture (due to the multiple attempts that may be necessary to take a sample during the hospitalization),
- •For which at least one vein is visible or palpable on an upper limb,
- •Without venous puncture since admission in the department,
- •Patient who did not receive a topical anesthetic before the venous puncture (Emla type)
- •Communicating patient, able to assess their pain on a digital scale,
- •Patients with affiliation to a social security system or beneficiary ,
- •Written informed consent (IC) obtained.
排除标准
- •Patient already included,
- •Previous pain localized to the upper limbs,
- •Hematoma at the planned site of skin-vascular breakage,
- •Hemiplegic or quadriplegic patient,
- •Patient with lymphedema in the upper limbs,
- •Patient with behavioral disorders that may interfere with the proper functioning of the sampling,
- •Patient with cognitive impairment preventing understanding of the study and adequate assessment pain (CODEX cognitive score of category C or D),
- •Patient placed under legal protection (guardianship).
研究组 & 干预措施
Rubber tourniquet
The blood sample is taken with a rubber tourniquet,
干预措施: Rubber tourniquet (Procedure)
Fabric tourniquet
The blood sample is taken with a a fabric tourniquet
干预措施: Fabric tourniquet (Procedure)
No tourniquet
The blood sample is taken without tourniquet
干预措施: Without tourniquet (Procedure)
结局指标
主要结局
Comparison of the maximum pain associated with venous puncture, in elderly patients with a visible or palpable vein depending on the method of sampling.
时间窗: At the end of the study, an average of 12 month
Assessment of maximum pain on examination (including pain from skin-vascular invasion and tourniquet pain)by the patient using a verbal numerical scale (EN) rated from 0 to 10. This measure concerns the 1st sampling as a whole, regardless of the number of attempts necessary to obtain it and their terms
次要结局
- Comparison of the frequency of side effects: malaise, hematoma at the cutaneous-vascular break site, according to the venous sampling procedure ; hematoma and / or skin abrasion at the tourniquet, in patients collected with tourniquet(At the end of the study, an average of 12 month)
- Estimation of the pain due to the tourniquet and to the cutaneous-vascular breaks in patients where sample was taken with tourniquet(At the end of the study, an average of 12 month)
- Comparison of the frequency of hemolysis of the sample, according to the venous sampling procedure(At the end of the study, an average of 12 month)
- Estimation of the influence of the nurse's experience on the efficiency of venous sampling on the duration of blood collection(At the end of the study, an average of 12 month)
- Estimation of the influence of the nurse's experience on the efficiency of venous sampling on pain(At the end of the study, an average of 12 month)
- Comparison of the number of cutaneous-vascular breaks necessary for obtain a blood sample, according to the venous sampling procedure(At the end of the study, an average of 12 month)
- Comparison of the ease of taking the sample by caregivers, according to the venous sampling procedure(At the end of the study, an average of 12 month)
- Estimation of the influence of the type of material used on the efficiency of venous sampling on the duration of blood collection(At the end of the study, an average of 12 month)
- Frequency of failures (regardless of the venous sampling method used) and refusal of the sample venous without tourniquet(At the end of the study, an average of 12 month)
- Proportion of elderly patients with a visible or palpable vein(At the end of the study, an average of 12 month)
- Comparison of the time taken to obtain a blood sample by caregivers, according to the venous sampling procedures(At the end of the study, an average of 12 month)
- Estimation of the influence of the type of material used on the efficiency of venous sampling on pain(At the end of the study, an average of 12 month)