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

NCT05226364 | Completed

• 2 other identifiers: CHRD03192021-A02936-35
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Venous Puncture

Keywords

Venous Puncture; Tourniquet; Pain; Elderly people

Outcome Measures

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.

  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 Outcomes (12)

• Proportion of elderly patients with a visible or palpable vein

  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 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

• 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 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

Study Arms (3)

Rubber tourniquet

EXPERIMENTAL

The blood sample is taken with a rubber tourniquet,

Procedure: Rubber tourniquet

Fabric tourniquet

EXPERIMENTAL

The blood sample is taken with a a fabric tourniquet

Procedure: Fabric tourniquet

No tourniquet

EXPERIMENTAL

The blood sample is taken without tourniquet

Procedure: Without tourniquet

Interventions

Rubber tourniquet PROCEDURE

The blood sample is taken with a rubber tourniquet

Rubber tourniquet

Fabric tourniquet PROCEDURE

The blood sample is taken with a fabric tourniquet

Fabric tourniquet

Without tourniquet PROCEDURE

The blood sample is taken without tourniquet

No tourniquet

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hôpital NOVO: lead

Study Sites (5)

Geriatric Department - CHRU Brest

Brest, 29600, France

Location

Geriatric Department - CH Cholet

Cholet, 49 300, France

Location

Geriatric Department - Hospital Louis Mourier - Colombes

Colombes, 92700, France

Location

Geriatric Department - Intercommunal hospital center - Créteil

Créteil, 94010, France

Location

Geriatric Department - Hospital René Dubos - Pontoise

Pontoise, 95300, France

Location

MeSH Terms

Conditions

Pain

Interventions

Tourniquets

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Vella QUILLIEN

  Hospital René Dubos - Pontoise

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: February 7, 2022
• Study Start: May 18, 2022
• Primary Completion: July 11, 2024
• Study Completion: July 11, 2024
• Last Updated: December 31, 2024

Record last verified: 2024-12

Locations

FR (5)