Clinical trial NCT05226364: Effect of Tourniquet Abstention on Pain Reduction in Venous Sampling in the Elderly People
Official title: Effect of Tourniquet Abstention on Pain Reduction in Venous Sampling in the Elderly People : Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Puncture
Keywords: Venous Puncture
Tourniquet
Pain
Elderly people
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 240
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This prospective study evaluates the effect of abstaining from tourniquets on pain reduction during the venous puncture of the elderly people.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* ≥ 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Comparison of the maximum pain associated with venous puncture, in elderly patients with a visible or palpable vein depending on the method of sampling.
timeFrame: At the end of the study, an average of 12 month
Secondary outcomes:
measure: Proportion of elderly patients with a visible or palpable vein
timeFrame: At the end of the study, an average of 12 month
measure: Comparison of the number of cutaneous-vascular breaks necessary for obtain a blood sample, according to the venous sampling procedure
timeFrame: At the end of the study, an average of 12 month
measure: Comparison of the time taken to obtain a blood sample by caregivers, according to the venous sampling procedures
timeFrame: At the end of the study, an average of 12 month
measure: Comparison of the ease of taking the sample by caregivers, according to the venous sampling procedure
timeFrame: At the end of the study, an average of 12 month
measure: Estimation of the pain due to the tourniquet and to the cutaneous-vascular breaks in patients where sample was taken with tourniquet
timeFrame: At the end of the study, an average of 12 month
measure: 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
timeFrame: At the end of the study, an average of 12 month
measure: Comparison of the frequency of hemolysis of the sample, according to the venous sampling procedure
timeFrame: At the end of the study, an average of 12 month
measure: Estimation of the influence of the nurse's experience on the efficiency of venous sampling on the duration of blood collection
timeFrame: At the end of the study, an average of 12 month
measure: Estimation of the influence of the nurse's experience on the efficiency of venous sampling on pain
timeFrame: At the end of the study, an average of 12 month
measure: Estimation of the influence of the type of material used on the efficiency of venous sampling on pain
timeFrame: At the end of the study, an average of 12 month
measure: Estimation of the influence of the type of material used on the efficiency of venous sampling on the duration of blood collection
timeFrame: At the end of the study, an average of 12 month
measure: Frequency of failures (regardless of the venous sampling method used) and refusal of the sample venous without tourniquet
timeFrame: At the end of the study, an average of 12 month
Other outcomes:
Locations:
city: Brest
country: France
facility: Geriatric Department - CHRU Brest
city: Cholet
country: France
facility: Geriatric Department - CH Cholet
city: Colombes
country: France
facility: Geriatric Department - Hospital Louis Mourier - Colombes
city: Créteil
country: France
facility: Geriatric Department - Intercommunal hospital center - Créteil
city: Pontoise
country: France
facility: Geriatric Department - Hospital René Dubos - Pontoise
Study officials:
affiliation: Hospital René Dubos - Pontoise
name: Vella QUILLIEN
role: PRINCIPAL_INVESTIGATOR
References: