Venous PunctureNO-GARROTNCT05226364
Effect of Tourniquet Abstention on Pain Reduction in Venous Sampling in the Elderly People
A study testing Rubber tourniquet, Fabric tourniquet and Without tourniquet in people with Venous Puncture, run by Hôpital NOVO at 5 sites in France.
Trial summary
This prospective study evaluates the effect of abstaining from tourniquets on pain reduction during the venous puncture of the elderly people. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Venous Puncture
- What is being tested?
- Rubber tourniquet, Fabric tourniquet and Without tourniquet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 5 sitesFrance
- Study dates
- 18 May 2022to 11 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ≥ 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)
Show all 9Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Geriatric Department - CHRU Brest
Brest, 29600
Geriatric Department - CH Cholet
Cholet, 49 300
Geriatric Department - Hospital Louis Mourier - Colombes
Colombes, 92700
Geriatric Department - Intercommunal hospital center - Créteil
Créteil, 94010
Geriatric Department - Hospital René Dubos - Pontoise
Pontoise, 95300
About this study
Official title: 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.
Read the 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.
- Conditions
- Venous Puncture
- Being tested
- Rubber tourniquet, Fabric tourniquet, Without tourniquet
- Keywords
- Venous Puncture, Tourniquet, Pain, Elderly people
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rubber tourniquetProcedure or surgery
The blood sample is taken with a rubber tourniquet
Fabric tourniquetProcedure or surgery
The blood sample is taken with a fabric tourniquet
Without tourniquetProcedure or surgery
The blood sample is taken without tourniquet
| Study group | Role | What they receive |
|---|---|---|
| Rubber tourniquet | Experimental | The blood sample is taken with a rubber tourniquet, Receives: Procedure: Rubber tourniquet |
| Fabric tourniquet | Experimental | The blood sample is taken with a a fabric tourniquet Receives: Procedure: Fabric tourniquet |
| No tourniquet | Experimental | The blood sample is taken without tourniquet Receives: Procedure: Without tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the end of the study, an average of 12 month
Secondary outcomes (12)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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, ...
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: At the end of the study, an average of 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start18 May 2022
- Primary completion11 Jul 2024
- Study completion11 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous PunctureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vella QUILLIEN, Principal investigator, Hospital René Dubos - Pontoise
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226364
- Sponsor's protocol ID
- CHRD0319
- Other IDs
- 2021-A02936-35
- Acronym
- NO-GARROT
- Status last verified
- Dec 2024
- First submitted
- 15 Dec 2021
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tourniquet Abstention on Pain Reduction in Venous Sampling in the Elderly People : Randomized Trial
- ClinicalTrials.gov ID
- NCT05226364
- Acronym / sponsor ID
- NO-GARROT / CHRD0319
- Conditions
- Venous Puncture
- Keywords
- Venous Puncture, Tourniquet, Pain, Elderly people
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 18 May 2022 (actual)
- Primary completion
- 11 Jul 2024 (actual)
- Study completion
- 11 Jul 2024 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rubber tourniquet | Experimental | Procedure: Rubber tourniquetThe blood sample is taken with a rubber tourniquet, |
| Fabric tourniquet | Experimental | Procedure: Fabric tourniquetThe blood sample is taken with a a fabric tourniquet |
| No tourniquet | Experimental | Procedure: Without tourniquetThe blood sample is taken without tourniquet |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- ≥ 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,
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rubber tourniquetThe blood sample is taken with a rubber tourniquet | Procedure or surgery | Rubber tourniquet |
| Fabric tourniquetThe blood sample is taken with a fabric tourniquet | Procedure or surgery | Fabric tourniquet |
| Without tourniquetThe blood sample is taken without tourniquet | Procedure or surgery | No tourniquet |
Primary outcome
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
12 secondary outcomes
Proportion of elderly patients with a visible or palpable vein
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At the end of the study, an average of 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vella QUILLIEN principal investigator
Hospital René Dubos - Pontoise
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rubber tourniquet, Fabric tourniquet and Without tourniquet in people with Venous Puncture, run by Hôpital NOVO at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: At the end of the study, an average of 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.