UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054453 |
|---|---|
| Receipt number | R000062195 |
| Scientific Title | Usefulness of ultrasound-guided peripheral venous access by ICU nurses |
| Date of disclosure of the study information | 2024/05/25 |
| Last modified on | 2025/06/02 17:30:35 |
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Basic information
Public title
Usefulness of ultrasound-guided peripheral venous access by ICU nurses
Acronym
Usefulness of ultrasound-guided peripheral venous access by ICU nurses
Scientific Title
Usefulness of ultrasound-guided peripheral venous access by ICU nurses
Scientific Title:Acronym
Usefulness of ultrasound-guided peripheral venous access by ICU nurses
Region
| Japan |
Condition
Condition
All patients who are expected to be in the intensive care unit for more than 3 days and require peripheral venous channeling
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Ultrasound is a noninvasive, real-time device that collects information about a patient's body. When it is difficult for a nurse to secure a peripheral venous system, a physician often performs an ultrasound-guided puncture. The nurse secures the peripheral venous system by visually and tactilely recognizing the vessels, selecting the vessels, and puncturing them. The success of peripheral venous channeling depends largely on the nurses' experience. Patients entering the intensive care unit are often in a state of shock, on high doses of hypertensive medications, or have edema due to a combination of problems such as fluid overload and low protein, making it very difficult to select a vessel. Failure to do so may result in multiple punctures, which can cause continued patient distress and lead to treatment interruptions, such as patient discouragement or refusal of treatment. In addition, because arteries and nerves accompany superficial venous vessels, the risk of accidental puncture of arteries or nerves is very high if the indwelling needle penetrates outside the venous vessels. Other problems include delays in examination and treatment initiation due to repeated failures, insertion of central venous catheters, which are more dangerous than peripheral venous catheter placement as an alternative means, and increased costs due to repeated venipuncture attempts. Therefore, it is important to take measures to prevent venipuncture failure with fewer punctures.
Most studies on ultrasound-guided vascular puncture by nurses in Japan are related to dialysis, and there are few studies on peripheral venous channeling performed by nurses. The purpose of this study is to verify whether ultrasound-guided peripheral venous channeling can increase the success rate of peripheral venous channeling by nurses and decrease the number of puncture attempts when sufficient educational time is provided.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of attempts and success rate of securing peripheral venous tracts
Key secondary outcomes
Incidence of complications (pain, phlebitis, obstruction, nerve damage, hematoma, arterial puncture)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Since it is expected that the difficulty of peripheral venipuncture is greatly influenced by the ability or inability of the puncturer to see and palpate the patient's blood vessels, the procedure is divided into two groups: cases in which blood vessels can be seen and palpated, and cases in which they cannot be seen and palpated.
The practitioner confirms whether or not the patient's blood vessels can be seen and palpated when peripheral venous channeling is necessary. If the vessels can be seen and palpated, the patient is randomly assigned to the group in which the vessels can be seen and palpated, and puncture is performed according to either the ultrasound-guided method or the conventional method. The number of puncture attempts in the same patient is limited to two. If the peripheral venous system cannot be secured after two puncture attempts using the specified puncture method, puncture the patient using the other puncture method. In this case, the number of puncture attempts is also limited to two. In the case of failure, the study is terminated, and the nurse is free to choose any subsequent puncture method. Successful puncture will be defined as the presence of retrograde bleeding through the indwelling catheter and no extravascular leakage due to drug administration. Only both upper extremities can be punctured; puncture of other parts of the body will not be included in the study. If it was deemed difficult to attempt puncture using the conventional method due to difficulty in visualization or palpation by the nurse, the insertion using the conventional method was considered to have been abandoned. The total number of failed insertion attempts will be treated as the same as two failed puncture attempts.
Interventions/Control_2
Since it is expected that the difficulty of peripheral venipuncture is greatly influenced by the ability or inability of the puncturer to see and palpate the patient's blood vessels, the procedure is divided into two groups: cases in which blood vessels can be seen and palpated, and cases in which they cannot be seen and palpated.
The practitioner confirms whether or not the patient's blood vessels can be seen and palpated when peripheral venous channeling is necessary. If the vessel cannot be visualized or palpated, the patient will be randomly assigned to the non-visible/non-palpable group and puncture will be performed according to the ultrasound-guided method or the conventional method. The number of puncture attempts in the same patient is limited to two. If the peripheral venous system cannot be secured after two puncture attempts using the specified puncture method, puncture the patient using the other puncture method. In this case, the number of puncture attempts is also limited to two. In the case of failure, the study is terminated, and the nurse is free to choose any subsequent puncture method. Successful puncture will be defined as the presence of retrograde bleeding through the indwelling catheter and no extravascular leakage due to drug administration. Only both upper extremities can be punctured; puncture of other parts of the body will not be included in the study. If it was deemed difficult to attempt puncture using the conventional method due to difficulty in visualization or palpation by the nurse, the insertion using the conventional method was considered to have been abandoned. The total number of failed insertion attempts will be treated as the same as two failed puncture attempts.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who enter the intensive care unit between April 1, 2024 and September 30, 2024 and are expected to stay in the unit for at least 3 days, and patients who are expected to stay in the unit for at least 3 days are also eligible on the first or second day.
Key exclusion criteria
Patients under 18 years of age, patients in need of urgent and life-saving peripheral venous channeling, and patients in unstable general condition who are expected to have difficulty with the puncture attempt.
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Miike |
| Middle name | |
| Last name | Michiko |
Organization
Kumamoto University Hospital
Division name
ICU
Zip code
860-0811
Address
1-1-1 Honjo, Chuo-ku, Kumamoto City
TEL
096-373-7031
michiko-wataji@kuh.kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Akifumi |
| Middle name | |
| Last name | Kamibeppu |
Organization
Kumamoto University Hospital
Division name
ICU
Zip code
860-0811
Address
1-1-1 Honjo, Chuo-ku, Kumamoto City
TEL
096-373-7031
Homepage URL
akifumi-kamibep@kuh.kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nothing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kumamoto University Hospital ICU
Address
1-1-1 Honjo, Chuo-ku, Kumamoto City
Tel
096-373-7031
akifumi-kamibep@kuh.kumamoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
34
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 22 | Day |
Last modified on
| 2025 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062195
