Using ultrasound to guide placement of a tube in a vein in the arm or leg
| ISRCTN | ISRCTN18025891 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18025891 |
- Submission date
- 04/01/2022
- Registration date
- 05/01/2022
- Last edited
- 27/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Peripheral intravenous access is required to insert a tube into a vein to administer fluids or medication.
Peripheral intravenous access is a common clinical procedure, and difficult peripheral intravenous access is a common problem in caring for emergency and critically ill patients. During difficult intravenous access in clinical practice, the timeliness of immediate treatment is affected, endangering the patient’s safety. Repeated injections increase pressure on nursing staff and consume more nursing hours and medical costs. Accordingly, this study aimed to test the effect of ultrasound guidance in difficult peripheral intravenous access.
Who can participate?
Adult volunteers aged 20 years or above, with difficult intravenous access.
What does the study involve?
This study was a randomized crossover study. Each individual underwent ultrasound-guided and traditional blind peripheral intravenous access in alternation. Individuals in Group A underwent ultrasound-guided intravenous cannulation in the right arm and traditional intravenous cannulation in the left arm, while individuals in Group B underwent traditional intravenous cannulation in the right arm and ultrasound-guided intravenous cannulation in the left arm. All participants receive the same outcome measurements, including Overall success rate, First attempt success rate, Number of attempts, Procedure time, Side effect incidence rate.
What are the possible benefits and risks of participating?
The possible benefits are the ultrasound-guided peripheral intravenous access protocol can improve the first attempt success rate, overall success rate and reduce the number of attempts. The possible risks include injection pain and bleeding, which are the same to the control group of traditional blind peripheral intravenous access.
Where is the study run from?
Chi-Mei medical center (Taiwan)
When is the study starting and how long is it expected to run for?
November 2017 to November 2019
Who is funding the study?
Taiwan nurses association
Who is the main contact?
Chia-Chi Kuo, kuochiachi63@gmail.com
Contact information
Principal Investigator
No. 2, Sec. W.
Jiapu Rd.
Puzi City
Chiay
613016
Taiwan
 ORCID ID |
0000-0003-2194-9007 |
|---|---|
| Phone | +886-05-3628800 ext. 2625 |
| cckuo@mail.cgust.edu.tw |
Study information
| Study design | Interventional randomized crossover study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Ultrasound-guided peripheral intravenous access in adults: a randomized crossover controlled trial |
| Study objectives | Ultrasound guidance could significantly improve the first attempt success rate, overall success rate, and reduce the number of attempts in difficult peripheral intravenous access. |
| Ethics approval(s) | Approved 02/01/2018, Institutional review board of Chi-Mei medical center (No.901, Zhonghua Rd., Yongkang Dist., Tainan City 710, Taiwan; +886(6)2812811#53720; csr2930@mail.chimei.org.tw), ref: 10612-002. |
| Health condition(s) or problem(s) studied | Effects of ultrasound-guided peripheral intravenous access protocol on first attempt success rate, overall success rate, and number of attempts in patients with difficult peripheral intravenous access. |
| Intervention | This study was a non-blinded, randomized crossover study. Convenient sampling was applied to enroll 36 adult volunteers with the problem of difficult peripheral intravenous access (with a score of 3 or 4 for difficult intravenous access, i.e. with invisible but palpable veins or invisible and impalpable veins) in a medical center in southern Taiwan. The random sequence was generated by block randomization and was concealed in a sealed envelope. Each individual underwent ultrasound-guided and traditional blind peripheral intravenous access in alternation. Ultrasound-guided peripheral intravenous access was performed using a high-frequency 12 MHz ultrasound probe, and a two-person, dynamic, and longitudinal and transversal scanning method was adopted to help locate the position, direction, and depth of the peripheral vein. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Data collected during the injection process: 1. First attempt success rate 2. Overall success rate 3. Number of attempts |
| Secondary outcome measures | Data collected during the injection process: 1. Procedure time 2. Side effect incidence rate |
| Overall study start date | 27/11/2017 |
| Completion date | 30/11/2019 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 36 |
| Total final enrolment | 36 |
| Key inclusion criteria | 1. Volunteers with difficult intravenous access: This study used the difficult intravenous access score (Benkhadra et al., 2012) to evaluate the degree of difficult intravenous access of the participants, with a score of 1 indicating visible and palpable veins, a score of 2 indicating visible but impalpable veins, a score of 3 indicating invisible but palpable veins, and a score of 4 indicating invisible and impalpable veins. Those with an evaluation score result of 3 or 4 were classified as having difficult intravenous access 2. Adults aged over 20 years, without visual, hearing, or mental disorders 3. Those who were alert and conscious and can communicate in Mandarin or Taiwanese 4. Those who are literate with at least an elementary education |
| Key exclusion criteria | 1. Peripheral neurovascular disorders 2. Peripheral local tissue inflammatory diseases 3. Contraindications of peripheral intravenous access |
| Date of first enrolment | 15/12/2018 |
| Date of final enrolment | 30/11/2019 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Yongkang Dist.
Tainan City
710
Taiwan
Sponsor information
Other
4F., No. 281, Sec. 4
Xinyi Rd.
Da’an Dist.
Taipei
106439
Taiwan
| Phone | +886-02-27552291 |
|---|---|
| twna@twna.org.tw | |
| Website | https://www.twna.org.tw/ |
"ROR" |
https://ror.org/02px13636 |
Funders
Funder type
Other
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- 台灣護理學會, TWNA
- Location
- Taiwan
Results and Publications
| Intention to publish date | 01/02/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 20/01/2025 | 27/01/2025 | Yes | No |
Editorial Notes
27/01/2025: Publication reference added.
05/01/2022: Trial's existence confirmed by Institutional review board of Chi-Mei medical center
