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Completed

NCT Number: NCT05226364

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

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

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Key information

Conditions

Venous Puncture Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geriatric Department - CHRU Brest, Brest, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Rubber tourniquet

Procedure

The blood sample is taken with a rubber tourniquet

Fabric tourniquet

Procedure

The blood sample is taken with a fabric tourniquet

Without tourniquet

Procedure

The blood sample is taken without tourniquet

Primary outcomes

  1. Comparison of the maximum pain associated with venous puncture, in elderly patients with a visible or palpable vein depending on the method of sampling.

    Time frame: 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

Secondary outcomes

  1. Proportion of elderly patients with a visible or palpable vein

    Time frame: At the end of the study, an average of 12 month

    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

  2. Comparison of the number of cutaneous-vascular breaks necessary for obtain a blood sample, according to the venous sampling procedure

    Time frame: At the end of the study, an average of 12 month

    Compilation of the number of cutaneous-vascular ruptures performed until obtention of a sample sent to laboratory

  3. Comparison of the time taken to obtain a blood sample by caregivers, according to the venous sampling procedures

    Time frame: At the end of the study, an average of 12 month

    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

  4. Comparison of the ease of taking the sample by caregivers, according to the venous sampling procedure

    Time frame: At the end of the study, an average of 12 month

    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.

  5. Estimation of the pain due to the tourniquet and to the cutaneous-vascular breaks in patients where sample was taken with tourniquet

    Time frame: At the end of the study, an average of 12 month

    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.

  6. 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

    Time frame: At the end of the study, an average of 12 month

    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, ...

  7. Comparison of the frequency of hemolysis of the sample, according to the venous sampling procedure

    Time frame: At the end of the study, an average of 12 month

    Proportion of samples having to be carried out again for hemolysis

  8. Estimation of the influence of the nurse's experience on the efficiency of venous sampling on the duration of blood collection

    Time frame: At the end of the study, an average of 12 month

    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.

  9. Estimation of the influence of the nurse's experience on the efficiency of venous sampling on pain

    Time frame: At the end of the study, an average of 12 month

    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.

  10. Estimation of the influence of the type of material used on the efficiency of venous sampling on pain

    Time frame: At the end of the study, an average of 12 month

    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.

  11. Estimation of the influence of the type of material used on the efficiency of venous sampling on the duration of blood collection

    Time frame: At the end of the study, an average of 12 month

    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.

  12. Frequency of failures (regardless of the venous sampling method used) and refusal of the sample venous without tourniquet

    Time frame: At the end of the study, an average of 12 month

    Number of failures (regardless of the venous sampling method used) and refusal of the sample venous without tourniquet

Sponsors and collaborators

Lead sponsor

Hôpital NOVO

Other

Registry information

Official study title

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

Acronym: NO-GARROT

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 7, 2022
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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