Effect of Tourniquet Abstention on Pain Reduction in Venous Sampling in the Elderly People

Venous Puncture Clinical Trial

— NO-GARROT  

Official title:

Effect of Tourniquet Abstention on Pain Reduction in Venous Sampling in the Elderly People : Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05226364
• Other study ID #: CHRD0319
• Secondary ID: 2021-A02936-35
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2022
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: Hôpital NOVO
• Contact: Maryline DELATTRE
• Phone: 0033130754131
• Email: maryline.delattre[@]ght-novo.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Venous Puncture

Intervention

Procedure:
• Rubber tourniquet
The blood sample is taken with a rubber tourniquet
• Fabric tourniquet
The blood sample is taken with a fabric tourniquet
• Without tourniquet
The blood sample is taken without tourniquet

Locations

Country	Name	City	State
France	Geriatric Department - CHRU Brest	Brest
France	Geriatric Department - CH Cholet	Cholet
France	Geriatric Department - Hospital Louis Mourier - Colombes	Colombes
France	Geriatric Department - Intercommunal hospital center - Créteil	Créteil
France	Geriatric Department - Hospital René Dubos - Pontoise	Pontoise

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital NOVO

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the maximum pain associated with venous puncture, in elderly patients with a visible or palpable vein depending on the method of sampling.	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	At the end of the study, an average of 12 month
Secondary	Proportion of elderly patients with a visible or palpable vein	Estimate of the proportion of patients corresponding to phlebological prerequisites of the study (vein visible or palpable on at least one of the two upper limbs) on all elderly people meeting the other selection criteria upon admission to the service for the duration of the research	At the end of the study, an average of 12 month
Secondary	Comparison of the number of cutaneous-vascular breaks necessary for obtain a blood sample, according to the venous sampling procedure	Compilation of the number of cutaneous-vascular ruptures performed until obtention of a sample sent to laboratory	At the end of the study, an average of 12 month
Secondary	Comparison of the time taken to obtain a blood sample by caregivers, according to the venous sampling procedures	Measurement of the time required for this sample using timing from the moment the nurse is ready and until the end of the filling of the first tube sampled. This timing is performed by the caregiver himself and not by the third party who will collect the patient's pain and who is not present, in order to avoid any external influence linked to the performance of the gesture during the evaluation of the main criterion	At the end of the study, an average of 12 month
Secondary	Comparison of the ease of taking the sample by caregivers, according to the venous sampling procedure	Collection of the ease of performing the sampling by the caregivers via a Likert-type question (very easy, rather easy, rather difficult, very difficult) filled in after each sampling.; In addition, the need to change arms or to call on another caregiver to perform the procedure will be noted.	At the end of the study, an average of 12 month
Secondary	Estimation of the pain due to the tourniquet and to the cutaneous-vascular breaks in patients where sample was taken with tourniquet	Verbal numerical scale measurements of tourniquet pain and pain due to vascular break (groups with tourniquet only).; 0 = No pain, 5 = moderate pain and 10 = Worst possible pain.	At the end of the study, an average of 12 month
Secondary	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	The presence of hematoma (s) will be observed in each group the next day of the sample by a caregiver separate from the one who performed the sample. The caregiver will also note the presence of skin abrasions related to possible use of tourniquet. Other unwanted events will also be collected, in particular: vagal unease during or after the sample, hemorrhage, ...	At the end of the study, an average of 12 month
Secondary	Comparison of the frequency of hemolysis of the sample, according to the venous sampling procedure	Proportion of samples having to be carried out again for hemolysis	At the end of the study, an average of 12 month
Secondary	Estimation of the influence of the nurse's experience on the efficiency of venous sampling on the duration of blood collection	Estimation of the effect of the mode of venipuncture (arm), according to the experience of the nurse on the duration of blood collection.; The duration of the blood sampling is expressed in minute.	At the end of the study, an average of 12 month
Secondary	Estimation of the influence of the nurse's experience on the efficiency of venous sampling on pain	Estimation of the effect of the mode of venipuncture (arm), according to the experience of the nurse on pain.; Verbal numerical scale measurements was used : 0 = No pain, 5 = moderate pain and 10 = Worst possible pain.	At the end of the study, an average of 12 month
Secondary	Estimation of the influence of the type of material used on the efficiency of venous sampling on pain	Estimation of the effect of the mode of venipuncture (arm), according to the type of material (butterfly needle, diameter) on pain.; Verbal numerical scale measurements was used : 0 = No pain, 5 = moderate pain and 10 = Worst possible pain.	At the end of the study, an average of 12 month
Secondary	Estimation of the influence of the type of material used on the efficiency of venous sampling on the duration of blood collection	Estimation of the effect of the mode of venipuncture (arm), according to the type of material (butterfly needle, diameter) on the duration of blood collection.; The duration of the blood sampling is expressed in minute.	At the end of the study, an average of 12 month
Secondary	Frequency of failures (regardless of the venous sampling method used) and refusal of the sample venous without tourniquet	Number 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