Clinical Research Plan for the Safety and Accuracy of Ultrasound-guided Radial Artery
Phase: NA
Conditions: Surgical Patients
Sponsor: Nanjing First Hospital, Nanjing Medical University

Informed Consent Form Version Number and Date:
v 1.0 2023-07-22
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Scheme Version number and date: v 1.0
2023 07 22
Informed consent for clinical studies on safety and
precision of radial artery catheterization
Dear patients:
You will be invited to attend a clinical study. This informed consent
form provides you some information to help you decide whether to
participate
Add to this clinical study. Please read it carefully and ask any questions
to the investigator responsible for the study.
This study will be conducted jointly in the Department of Anesthesiology
of Nanjing First Hospital and Nanjing Jiangning Hospital of Traditional
Chinese Medicine, and an estimated 100 study participants will participate
voluntarily. This study has been reviewed and approved by the Ethics
Committee of Nanjing First Hospital and the Ethics Committee of Nanjing
Jiangning Hospital of Traditional Chinese Medicine, and 10 cases are expected
to be enrolled in Nanjing First Hospital.
If you wish, please read the following carefully.
Protocol name: Clinical study on the safety and precision of ultrasound-
guided radial artery puncture and catheterization
Protocol version number and date: v 1.0 2023-07-22
Informed Consent Form Version number and Date: v 1.0 2023-07-22
Research Center: Department of Anesthesiology, Nanjing First Hospital
Principal investigator: The Korean Wave
I. Research purpose
With the continuous development and clinical popularization of invasive
blood pressure monitoring technology (ABP), the safety of patient anesthesia
has been greatly guaranteed. The radial artery is superficial, and the
forearm has a dual blood supply to the radial and ulnar arteries, so it is
the first choice for arterial puncture and catheterization.
It has been reported in the literature that the distal quarter of the
forearm is the best insertion site for ultrasound-guided radial artery
puncture, and the selection of the middle radial artery forearm
catheterization improves the success rate and overall success rate of the
first puncture attempt, and reduces the incidence of hematoma during puncture.
Invasive radial artery puncture cannot completely avoid complications,
such as puncture hematoma, arterial occlusion, infection, pseudoaneurysm,
vasospasm, and neurovascular injury have been reported in the literature.

Informed Consent Form Version Number and Date:
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There are no recommendations for the best puncture site for radial artery
puncture. Therefore, it is particularly important to choose a more appropriate
and safe and accurate location as an ultrasound-guided radial artery puncture
catheter.
2. Study process and precautions
This study is intended to further compare the influence of radial artery
position by observing the position distance of radial artery (ulnar: radial),
radial artery (center) distance, vertical distance from skin, and radial
artery (ulnar: radial). At the same time, it is planned to observe the
success rate of first puncture, puncture insertion time, puncture number and
puncture related complications at different distances of the forearm during
radial artery puncture insertion. An estimated 100 study participants will
volunteer. The study period was from 22 July 2023 to 30 June 2024. If you
agree to participate in this study, we will number each subject to establish
the medical records. You make

Informed Consent Form Version Number and Date:
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Participation in the study is fully voluntary, and you can be informed of the
information and progress of the study, and decide to participate (continue)
or not (continue).
3. Who who can / can not participate
1. Inclusion criteria: (1) elective surgery patients scheduled to undergo
general anesthesia and invasive arterial blood pressure monitoring; (2) ASA grade
I~; (3) age 18 to 65 years; (4) agree to participate in this clinical study and
sign informed consent.
2. Exclusion criteria: (1) positive or suspicious positive Allen patients; (2)
peripheral vascular diseases; (3) coronary artery related diseases; (4) local
skin infection, rupture, scar and surgical history; (5) shock patients or
receiving strong heart drugs, vasoconstriction drugs; (6) peripheral nerve injury,
anatomical abnormalities and neurological function; (7) passive upper limb body
position, unable to complete ultrasound assessment.
Iv. Risk and discomfort
For you, all the information will be kept confidential. Invasive radial
artery puncture cannot completely avoid complications at certain times, such
as puncture hematoma, arterial occlusion, infection, pseudoaneurysm,
vasospasm, neurovascular injury, etc. The protective measures for the study
participants are: in the event of serious radial puncture complications
during the experiment, the experiment was immediately stopped immediately,
and the complications were treated actively and effectively.
Four, benefit
Studying your data will help improve the safety and precision of radial
artery catheterization. Study results will not be fed back to study
participants.
V. Funds issues
The cost of ultrasound examination in this project is free, and there is
no experimental operation other than treatment, so no research funds related
to the study. Also, you will not receive any form of remuneration.
Five, responsibility
As a subject, you have the following responsibilities: provide your
medical history and current physical condition; tell the study doctor of any

Informed Consent Form Version Number and Date:
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discomfort during the study, not taking restricted medication, food, etc.;
tell the study doctor if you have participated in or are currently
participating in other studies.
6. Privacy issues
If you decide to participate in this study, your participation in the
trial and your personal data during the trial are kept confidential.
Information that can identify you will not be disclosed to members outside of
the study team without your permission. All study members and study sponsors
are required to keep your identity confidential. Your file will be kept in a
locked file cabinet for researcher access only. To ensure that the study is
conducted in accordance with the regulations, members of the government
administration or the ethics review committee can access your personal data
at the study site if necessary. No personal information of you will be
disclosed on publication of the results of this study.
Besides this study, it is possible that your experimental data will be
used again in other future studies. You may also now declare rejecting other
studies than this study to utilize your medical records and experimental data.

Informed Consent Form Version Number and Date:
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Vii. Rights
If you are injured by participating in this study: you can receive free
treatment and / or corresponding compensation for any damage related to the
clinical study.
You may choose not to participate in this study or at any time notify
the investigator to withdraw from the study, your data will not be included
in the study results and any medical benefits and interests will not be
affected.
If you need other treatment, or if you do not comply with the study plan,
or have a study-related injury or for any other reason, the study physician
may terminate your continued participation in the study.
You can keep abreast of the information and progress of the study. If
you have any questions related to the study, contact the researcher at
02587155030, or any discomfort or injury occurred to you during the study,
or about the interests of participants in the study, you can contact the
hospital Ethics Committee at any time at 02552271064.

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I have read this informed consent form.
I have the opportunity to ask questions and all the questions have been
answered.
I understand that participation in this study is voluntary.
I may choose not to participate in this study or withdraw at any time
after notifying the investigator without discrimination or reporting
Well, any of my medical treatment and interests will not be affected.
If I need other treatment, or I do not comply with the study plan, or
have a study-related injury or for any other reason, the study physician may
terminate my continued participation in this study.
I will receive a copy of the informed consent form that I have jointly
signed with the investigator.
Finally, I decided to consent to participate in this study.
Study Participant Signature:
Signature Date:
Year _____ month _____ day
Contact number:
Signature of legal representative or guardian: _____________ Relationship with
study participants: ____________ Study participants can not sign informed
consent Reasons: _______________________________ Contact:
________________ Date: ____, _____, ______

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I have accurately informed the subject of the document, and he / she
had accurately read the informed consent form and demonstrated that the
subject had the opportunity to ask questions. I testified that he / she had
voluntarily agreed to it.
Investigator's signature:
Signature Date:
Year _____ month _____ day
Investigator Contact Number: