Effect of Tourniquet Abstention on Pain Reduction in Venous Sampling in the Elderly People (NO-GARROT)

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

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

Study Overview

• Status: Recruiting
• Conditions: Venous Puncture
• Intervention / Treatment: Procedure: Rubber tourniquet; Procedure: Fabric tourniquet; Procedure: Without tourniquet

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.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mathilde Wlodarczyk; Phone Number: 7199 0033130754040
• Study Contact Backup: Name: Maryline DELATTRE; Phone Number: 0033130754131; Email: maryline.delattre@ght-novo.fr

Study Locations

• France
  • Brest, France, 29600
    • Active, not recruiting
    • Geriatric Department - CHRU Brest
  • Cholet, France, 49 300
    • Recruiting
    • Geriatric Department - CH Cholet
    • Contact: Tiphaine RETAILLEAU; Phone Number: +33 2 41 49 68 34; Email: tiphaine.retailleau@ch-cholet.fr
  • Colombes, France, 92700
    • Recruiting
    • Geriatric Department - Hospital Louis Mourier - Colombes
    • Contact: Douma ATHENA; Phone Number: 0033 (1) 47 60 69 92; Email: athena9282@hotmail.fr
  • Créteil, France, 94010
    • Recruiting
    • Geriatric Department - Intercommunal hospital center - Créteil
    • Contact: Caroline Legal; Phone Number: +33 1 57 02 84 40; Email: caroline.legal@chicreteil.fr
  • Pontoise, France, 95300
    • Recruiting
    • Geriatric Department - Hospital René Dubos - Pontoise
    • Contact: Vella QUILLIEN; Phone Number: 0033 (1).30.75.48.72; Email: vella.quillien@ght-novo.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rubber tourniquet; The blood sample is taken with a rubber tourniquet,	Procedure: Rubber tourniquet; The blood sample is taken with a rubber tourniquet
Experimental: Fabric tourniquet; The blood sample is taken with a a fabric tourniquet	Procedure: Fabric tourniquet; The blood sample is taken with a fabric tourniquet
Experimental: No tourniquet; The blood sample is taken without tourniquet	Procedure: Without tourniquet; The blood sample is taken without tourniquet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Hôpital NOVO
• Investigators: Principal Investigator: Vella QUILLIEN, Hospital René Dubos - Pontoise

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Tourniquet; Elderly people; Venous Puncture
• Other Study ID Numbers: CHRD0319; 2021-A02936-35 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No