The Process of Blood Collection With a Vascular Imaging Device

NCT ID: NCT05678504

Last Updated: 2023-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-04-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study was planned to determine the effect of using a blood vessel imaging device (VID) and venous blood collection procedure on the pain and satisfaction level of the individual during phlebotomy. The randomized controlled experimental design study was carried out in a blood collection unit in a training and research hospital between 1-15 April 2022. The study sample was calculated as 100 people by power analysis and the method of drawing lots was applied to the groups. Data were collected using the patient identification form, visual analogue scale (VAS), and pain and satisfaction scales.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The population of the study consisted of adult individuals who benefited from polyclinic services and applied to the blood collection unit between the specified dates in a single center.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Phlebotomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Application Group

* Filling out the pre-initiative volunteering form and sociodemographic data
* Preparation of the individual for the transaction
* Monitoring the vein with a vein imaging device and operating a stopwatch
* Implementation of the initiative
* Stopping the stopwatch at the end of the process
* Application of VAS Pain and VAS satisfaction Scale

The phlebotomy procedure

Intervention Type DEVICE

The process of blood collection with a vascular imaging device

Control Group

* Filling out the pre-initiative volunteering form and sociodemographic data
* Preparation of the individual for the transaction
* Starting routine blood collection and starting the stopwatch
* Implementation of the initiative
* Stopping the stopwatch at the end of the process
* Application of VAS Pain and VAS satisfaction Scale

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

The phlebotomy procedure

The process of blood collection with a vascular imaging device

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Individuals between the ages of 18-65,
* Who wanted peripheral vascular access,
* Volunteered to participate in the study,
* Did not have any pain complaints,
* Did not take analgesics in the last 12 hours,
* Could be contacted,
* Did not have obesity, dehydration, peripheral oedema, or a cancer diagnosis and did not need emergency intervention.

Exclusion Criteria

* Those who do not meet the criteria for admission
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sakarya University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

özlem doğu

Assoc. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

özlem doğu, assoc. dr

Role: PRINCIPAL_INVESTIGATOR

Sakarya University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sakarya training and research hospital

Sakarya, Adapazarı, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Guillon P, Makhloufi M, Baillie S, Roucoulet C, Dolimier E, Masquelier AM. Prospective evaluation of venous access difficulty and a near-infrared vein visualizer at four French haemophilia treatment centres. Haemophilia. 2015 Jan;21(1):21-6. doi: 10.1111/hae.12513. Epub 2014 Oct 21.

Reference Type BACKGROUND
PMID: 25335191 (View on PubMed)

Amick AE, Feinsmith SE, Sell J, Davis EM, Wayne DB, Feinglass J, Barsuk JH. Ultrasound-Guided Peripheral Intravenous Catheter Insertion Training Reduces Use of Midline Catheters in Hospitalized Patients With Difficult Intravenous Access. J Patient Saf. 2022 Apr 1;18(3):e697-e703. doi: 10.1097/PTS.0000000000000910.

Reference Type BACKGROUND
PMID: 34570003 (View on PubMed)

Revill SI, Robinson JO, Rosen M, Hogg MI. The reliability of a linear analogue for evaluating pain. Anaesthesia. 1976 Nov;31(9):1191-8. doi: 10.1111/j.1365-2044.1976.tb11971.x.

Reference Type BACKGROUND
PMID: 1015603 (View on PubMed)

Kim K, Jeong HW, Lee Y. Performance Evaluation of Dorsal Vein Network of Hand Imaging Using Relative Total Variation-Based Regularization for Smoothing Technique in a Miniaturized Vein Imaging System: A Pilot Study. Int J Environ Res Public Health. 2021 Feb 6;18(4):1548. doi: 10.3390/ijerph18041548.

Reference Type RESULT
PMID: 33561967 (View on PubMed)

Zhang Z, Wang X, Zhang L, Lou X, Su X, Wang X, Sun F, He X. Infrared Vein Imaging for Insertion of Peripheral Intravenous Catheter for Patients Requiring Isolation for Severe Acute Respiratory Syndrome Coronavirus 2 Infection: A Nonrandomized Clinical Trial. J Emerg Nurs. 2022 Mar;48(2):159-166. doi: 10.1016/j.jen.2021.10.001. Epub 2021 Oct 12.

Reference Type RESULT
PMID: 35115182 (View on PubMed)

Aulagnier J, Hoc C, Mathieu E, Dreyfus JF, Fischler M, Le Guen M. Efficacy of AccuVein to facilitate peripheral intravenous placement in adults presenting to an emergency department: a randomized clinical trial. Acad Emerg Med. 2014 Aug;21(8):858-63. doi: 10.1111/acem.12437.

Reference Type RESULT
PMID: 25176152 (View on PubMed)

Eren H, Caliskan N. Effect of a Vein Imaging Device and of Fist Clenching on Determination of an Appropriate Vein and on Catheter Placement Time in Patients Receiving Chemotherapy: A Randomized Controlled Trial. Cancer Nurs. 2022 Mar-Apr 01;45(2):105-112. doi: 10.1097/NCC.0000000000000931.

Reference Type RESULT
PMID: 33654007 (View on PubMed)

Morata L, Bowers M. Ultrasound-Guided Peripheral Intravenous Catheter Insertion: The Nurse's Manual. Crit Care Nurse. 2020 Oct 1;40(5):38-46. doi: 10.4037/ccn2020240.

Reference Type RESULT
PMID: 33000131 (View on PubMed)

Skulec R, Callerova J, Vojtisek P, Cerny V. Two different techniques of ultrasound-guided peripheral venous catheter placement versus the traditional approach in the pre-hospital emergency setting: a randomized study. Intern Emerg Med. 2020 Mar;15(2):303-310. doi: 10.1007/s11739-019-02226-w. Epub 2019 Nov 7.

Reference Type RESULT
PMID: 31701317 (View on PubMed)

Yilmaz Kurt F, Aytekin Ozdemir A, Atay S. The Effects of Two Methods on Venipuncture Pain in Children: Procedural Restraint and Cognitive-Behavioral Intervention Package. Pain Manag Nurs. 2020 Dec;21(6):594-600. doi: 10.1016/j.pmn.2019.09.002. Epub 2019 Oct 15.

Reference Type RESULT
PMID: 31628067 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://www.infona.pl/resource/bwmeta1.element.elsevier-1d4b899a-3c22-30c7-a988-a5990180d27b

Zhu, Q., Zhang, Z., Liu, N., \& Sun, H. (2015). Near infrared hand vein image acquisition and extraction algorithm. Optics, 126(24), 5682-5687.

http://journal.acibadem.edu.tr/tr/download/article-file/1701903

CURRENT APPROACH TO PEDIATRIC VASCULAR ACCESS APPLICATIONS: VESSEL VISUALIZATION TECHNIQUE

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Blood vessel imaging device

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ergonomics in Ultrasound Procedures
NCT06417021 COMPLETED NA