Cystic FibrosisMUCOVEINENCT04226118
Efficacy of an Infrared Visualization Technique for the Identification of the Peripheral Venous Access Site in Patients With Cystic Fibrosis Aged 12 Years and Older
A study testing Vein Illumintion System device in people with Cystic Fibrosis, run by Hospices Civils de Lyon at 6 sites in France.
Trial summary
Cystic fibrosis is a rare chronic genetic disease that mainly affects the respiratory tract and the digestive system. Their management includes multi-year intravenous antibiotic treatments and repeated venous sampling. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Vein Illumintion System device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 6 sitesFrance
- Study dates
- 19 Jan 2021to 12 May 2022
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with cystic fibrosis aged 12 years and over
- Cystic Fibrosis diagnosis has been confirmed by a positive sweat test and/or 1 to 2 genetic mutations
- Patients requiring peripheral venous access (hand, forearm, or more of the elbow) for intravenous infusion with epicranial or short catheter, or for a blood sample
- Patients who have a score of 4 or higher on the A-DIVA scale (self-administered questionnaire completed by the IDE assessing the difficulty of peripheral venous access on a Likert scale from 0 to 8)
- Patients informed in writing of the terms of the study and provided written informed consent to participate (consent of the person in charge of parental authority if the patient is a minor).
- Patients affiliated to a social security system
Who cannot join
- Patient who has already participated in the study
- Patients who have a central venous approach
- Patients who have a venous approach of the midline type
- Patients taken care of for vital emergency
- Patient deprived of liberty or placed under tutorship or curatorship
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CRCM mixte de Giens
Giens, 83406
Hôpital Nord - CRCM adulte Marseille
Marseille, 13015
Hôpital enfant la Timone - CRCM pédiatrique Marseille
Marseille, 13385
Hôpital Arnaud de Villeneuve
Montpellier, 34090
Hôpital Pasteur - CRCM adulte Nice
Nice, 06001
Hôpital Lenval - CRCM pédiatrique Nice
Nice, 06202
About this study
Cystic fibrosis is a rare chronic genetic disease that mainly affects the respiratory tract and the digestive system. Their management includes multi-year intravenous antibiotic treatments and repeated venous sampling. The venous access is a source of difficulties that nurses who take care of these patients face on a daily basis. In addition, multiple attempts at punctures can induce anxiety and pain in patients. It is therefore important to limit failures.
Vein visualization technologies exist: guidance echo, portable trans lumination or infrared visualization can guide venipuncture and limit failures.
Read more
Compared with the guided echo or the portable trans lumination, the infrared visualization is easy to use and does not pose a risk for the patient. Nevertheless, studies evaluating this technique are few in chronic diseases and mainly conducted in young children.
This study aims to show that the use of a vein illumination system (VIS) should improve the peripheral venous access at the first attempt (thus limiting venous lesions) in adolescent and adult patients with cystic fibrosis, and improve comfort of the patient (pain, apprehension of the gesture).
Read the detailed description
Background :
Cystic fibrosis is a rare chronic genetic disease that mainly affects the respiratory tract and the digestive system. Their management includes multi-year intravenous antibiotic treatments and repeated venous sampling. The venous access is a source of difficulties that nurses who take care of these patients face on a daily basis. In addition, multiple attempts at punctures can induce anxiety and pain in patients. It is therefore important to limit failures.
Vein visualization technologies exist: guidance echo, portable trans lumination or infrared visualization can guide venipuncture and limit failures.
Compared with the guided echo or the portable trans lumination, the infrared visualization is easy to use and does not pose a risk for the patient. Nevertheless, studies evaluating this technique are few in chronic diseases and mainly conducted in young children.
This study aims to show that the use of a vein illumination system (VIS) should improve the peripheral venous access at the first attempt (thus limiting venous lesions) in adolescent and adult patients with cystic fibrosis, and improve comfort of the patient (pain, apprehension of the gesture).
Objectives of the study :
The main objective of the study is to demonstrate that the use of a vein illumination system (VIS) for the placement of a peripheral venous line or venous sampling on the hand, forearm or fold of the elbow improves peripheral venous access (PVA) successful on the first attempt.
The secondary objectives are :
- To study the efficacy of VIS for peripheral venous access (placement of a peripheral venous line or peripheral venous sampling in the hand, forearm or elbow) on the number of attempts.
- To study the impact of the use of SIV on the patient's pain felt during the peripheral venous access procedure.
- To study the impact of VIS on patient anxiety prior to peripheral venous access.
- To describe the nurses and nursing students satisfaction with the use of the VIS device for peripheral venous access.
- To study the determinants of the success of peripheral venous access at the first attempt among the characteristics of nurses and nursing students (age, year of obtaining their diploma, experience within the cystic fibrosis ressource and competence center).
- To describe the nurses and nursing students satisfaction with the use of A-DIVA scale.
Study design The study will last 36 months. It is an open and randomized multicenter cluster study, with sequential allocation of the device (stepped wedge allocation), comparing a group of patients benefiting from a technique of locating the puncture site by a venous illumination system for a peripheral venoux access (hand, forearm, fold of the elbow) to a group of patients whose veins are identified according to the usual modality of a peripheral venoux access. The cluster is defined by the Cystic Fibrosis Resource and Competence Center (CRCM).
Expected results
For the patients, the use of a venous illumination system device during the peripheral venous access should facilitate the success of the gesture on the first attempt, allowing to :
- Reduce their pain due to multiple attempts.
- Reduce their anxiety associated with peripheral venous access.
- Preserve their venous capital This could have an impact on their care, such as making it easier to consult for them and being less anxious about peripheral venous access.
For the nurses, using a venous illimunation system device could
- Reduce their apprehension of peripheral venous access gesture
- Save their time with fewer peripheral venous access are repeated. It is considered that this technique will be distributed to all Cytic Fibrosis Ressource and Competence Centers (CRCM) in order to improving the comfort of the chronically ill patient with repeated blood tests and intravenous treatments.
- Conditions
- Cystic Fibrosis
- Being tested
- Vein Illumintion System device
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vein Illumintion System deviceDevice
Spotting veins of a patient by use of a Vein Illumintion System device
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Patients who have a peripheral venous access by a classic procedure, without using a Vein Illumination System. |
| Experimental Group | Experimental | Patients who have a peripheral venous access by a procedure using a Vein Illumination System. Receives: Device: Vein Illumintion System device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients for whom peripheral venous access was performed from the first attempt.
Measured: at time of peripheral venous access
Secondary outcomes (4)
Number of attempts to place a peripheral venous line or perform peripheral venous
Measured: at time of peripheral venous access
Average pain score on Visual Analogue Scale (VAS) after successful peripheral venous access act.
Measured: at most 10 min after the venous act
Average anxiety score on State-Trait Anxiety Inventory (STAI-Y)
Measured: at most 10 min before the venous act
Proportion of nurses and nursing student satisfied by the use of a vein illumination system
Measured: at the end of the study ( at 14 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start19 Jan 2021
- Primary completion12 May 2022
- Study completion12 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226118
- Sponsor's protocol ID
- 69HCL19_0036
- Acronym
- MUCOVEINE
- Status last verified
- Jul 2022
- First submitted
- 9 Jan 2020
- Last updated
- 7 Jul 2022
- 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 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Infrared Visualization Technique for the Identification of the Peripheral Venous Access Site in Patients With Cystic Fibrosis Aged 12 Years and Older
- ClinicalTrials.gov ID
- NCT04226118
- Acronym / sponsor ID
- MUCOVEINE / 69HCL19_0036
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 12 May 2022 (actual)
- Study completion
- 12 May 2022 (actual)
- First posted
- 13 Jan 2020 (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.
Cystic fibrosis is a rare chronic genetic disease that mainly affects the respiratory tract and the digestive system. Their management includes multi-year intravenous antibiotic treatments and repeated venous sampling. The venous access is a source of difficulties that nurses who take care of these patients face on a daily basis. In addition, multiple attempts at punctures can induce anxiety and pain in patients. It is therefore important to limit failures.
Vein visualization technologies exist: guidance echo, portable trans lumination or infrared visualization can guide venipuncture and limit failures.
Compared with the guided echo or the portable trans lumination, the infrared visualization is easy to use and does not pose a risk for the patient. Nevertheless, studies evaluating this technique are few in chronic diseases and mainly conducted in young children.
This study aims to show that the use of a vein illumination system (VIS) should improve the peripheral venous access at the first attempt (thus limiting venous lesions) in adolescent and adult patients with cystic fibrosis, and improve comfort of the patient (pain, apprehension of the gesture).
Detailed description
Background :
Cystic fibrosis is a rare chronic genetic disease that mainly affects the respiratory tract and the digestive system. Their management includes multi-year intravenous antibiotic treatments and repeated venous sampling. The venous access is a source of difficulties that nurses who take care of these patients face on a daily basis. In addition, multiple attempts at punctures can induce anxiety and pain in patients. It is therefore important to limit failures.
Vein visualization technologies exist: guidance echo, portable trans lumination or infrared visualization can guide venipuncture and limit failures.
Compared with the guided echo or the portable trans lumination, the infrared visualization is easy to use and does not pose a risk for the patient. Nevertheless, studies evaluating this technique are few in chronic diseases and mainly conducted in young children.
This study aims to show that the use of a vein illumination system (VIS) should improve the peripheral venous access at the first attempt (thus limiting venous lesions) in adolescent and adult patients with cystic fibrosis, and improve comfort of the patient (pain, apprehension of the gesture).
Objectives of the study :
The main objective of the study is to demonstrate that the use of a vein illumination system (VIS) for the placement of a peripheral venous line or venous sampling on the hand, forearm or fold of the elbow improves peripheral venous access (PVA) successful on the first attempt.
The secondary objectives are :
- To study the efficacy of VIS for peripheral venous access (placement of a peripheral venous line or peripheral venous sampling in the hand, forearm or elbow) on the number of attempts.
- To study the impact of the use of SIV on the patient's pain felt during the peripheral venous access procedure.
- To study the impact of VIS on patient anxiety prior to peripheral venous access.
- To describe the nurses and nursing students satisfaction with the use of the VIS device for peripheral venous access.
- To study the determinants of the success of peripheral venous access at the first attempt among the characteristics of nurses and nursing students (age, year of obtaining their diploma, experience within the cystic fibrosis ressource and competence center).
- To describe the nurses and nursing students satisfaction with the use of A-DIVA scale.
Study design The study will last 36 months. It is an open and randomized multicenter cluster study, with sequential allocation of the device (stepped wedge allocation), comparing a group of patients benefiting from a technique of locating the puncture site by a venous illumination system for a peripheral venoux access (hand, forearm, fold of the elbow) to a group of patients whose veins are identified according to the usual modality of a peripheral venoux access. The cluster is defined by the Cystic Fibrosis Resource and Competence Center (CRCM).
Expected results
For the patients, the use of a venous illumination system device during the peripheral venous access should facilitate the success of the gesture on the first attempt, allowing to :
- Reduce their pain due to multiple attempts.
- Reduce their anxiety associated with peripheral venous access.
- Preserve their venous capital This could have an impact on their care, such as making it easier to consult for them and being less anxious about peripheral venous access.
For the nurses, using a venous illimunation system device could
- Reduce their apprehension of peripheral venous access gesture
- Save their time with fewer peripheral venous access are repeated. It is considered that this technique will be distributed to all Cytic Fibrosis Ressource and Competence Centers (CRCM) in order to improving the comfort of the chronically ill patient with repeated blood tests and intravenous treatments.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients who have a peripheral venous access by a classic procedure, without using a Vein Illumination System. |
| Experimental Group | Experimental | Device: Vein Illumintion System devicePatients who have a peripheral venous access by a procedure using a Vein Illumination System. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with cystic fibrosis aged 12 years and over
- Cystic Fibrosis diagnosis has been confirmed by a positive sweat test and/or 1 to 2 genetic mutations
- Patients requiring peripheral venous access (hand, forearm, or more of the elbow) for intravenous infusion with epicranial or short catheter, or for a blood sample
- Patients who have a score of 4 or higher on the A-DIVA scale (self-administered questionnaire completed by the IDE assessing the difficulty of peripheral venous access on a Likert scale from 0 to 8)
- Patients informed in writing of the terms of the study and provided written informed consent to participate (consent of the person in charge of parental authority if the patient is a minor).
Key exclusion criteria (5 listed)
- Patient who has already participated in the study
- Patients who have a central venous approach
- Patients who have a venous approach of the midline type
- Patients taken care of for vital emergency
- Patient deprived of liberty or placed under tutorship or curatorship
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 |
|---|---|---|
| Vein Illumintion System deviceSpotting veins of a patient by use of a Vein Illumintion System device | Device | Experimental Group |
Primary outcome
Proportion of patients for whom peripheral venous access was performed from the first attempt.
Time frame: at time of peripheral venous access
4 secondary outcomes
Number of attempts to place a peripheral venous line or perform peripheral venous
Time frame: at time of peripheral venous access
Average pain score on Visual Analogue Scale (VAS) after successful peripheral venous access act.
Time frame: at most 10 min after the venous act
Average anxiety score on State-Trait Anxiety Inventory (STAI-Y)
Time frame: at most 10 min before the venous act
Proportion of nurses and nursing student satisfied by the use of a vein illumination system
Time frame: at the end of the study ( at 14 months)
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 7 Jul 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vein Illumintion System device in people with Cystic Fibrosis, run by Hospices Civils de Lyon at 6 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 6 inclusion and 5 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 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Proportion of patients for whom peripheral venous access was performed from the first attempt. (time frame: at time of peripheral venous access). 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 7 Jul 2022.