Super Lizer in AV fistula creation

JRCT ID: jRCT1032240262

Registered date:06/08/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: End-stage kidney disease; hemodialysis
• Date of first enrollment: 06/08/2024
• Target sample size: 10
• Study type: Interventional

Intervention(s)

1. The researchers explain the study to the patient and obtain informed consent during the preoperative outpatient visit. Fistula creation site, either in the forearm or the upper arm, is determined and recorded.
2. On the day of surgery, the surgeons, in the operating room use ultrasound to measure the pre-intervention vessel diameter and blood flow with the use of tourniquet on the planned fistula creation site. The measurement data and ultrasound images are recorded.
3. Immediately prior to the surgery, the anesthesiologist performs stellate ganglion irradiation:
(a) The SuperLizer PX linearly polarized near-infrared therapeutic device (Tokyo Iken CO., LTD)'s SG tip unit is placed near the cervical stellate ganglion.
(b) Irradiation is performed in fixed mode (output: 90%, duration: 5 minutes).
4. After stellate ganglion irradiation, during surgical preparation, the surgeons measures the vessel diameter and blood flow with the use of tourniquet on the fistula creation site. The measurement data and ultrasound images, are recorded, and the final decision on the fistula creation site will be made.
5. Hemodialysis AV fistula creation is performed under local anesthesia.

Outcome(s)

• Primary Outcome: The difference/percentage change in cephalic vein diameter before and after stellate ganglion light irradiation (mm/%) (with the use of tourniquet: 150mmHg; more than 10 seconds; measured using ultrasound)

Secondary Outcome

(with the use of tourniquet: 150mmHg; more than 10 seconds; measured using ultrasound)
1. The difference/percentage change rate in vessel diameter before and after stellate ganglion light irradiation (mm/%):
A) Radial artery
B) Median artery
C) Deep vein
D)Brachial artery.
2. The pain VAS (Visual Analogue Scale) immediately after surgery.
3. Surgical duration.
4. The change of the planned fistula creation site from upper arm to forearm.
5. The fistula patency rate at 1 month: Confirmed by fistula sound, thrill, and ultrasound.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients who are scheduled for arteriovenous fistula creation for hemodialysis.
2. Patients who have a sufficient understanding of the research and provide consent.
3. Patients who are 18 years of age or older at the time of obtaining consent.

Exclude criteria

1. Patients with arterial vessel diameter at the planned arteriovenous fistula site of 1.5mm or less.
2. Patients with venous vessel diameter at the planned arteriovenous fistula site of 2mm or less after tourniquet
3. Patients with significant arterial sclerosis at the planned arteriovenous fistula site.
4. Patients with glaucoma.
5. Patients with cataracts.
6. Patients with BMI >= 35.
7. Patients with skin disorders at the planned irradiation site.
8. Patients who are considered unsuitable for participation in this study by the attending physician.

Related Information

• Primary Sponsor: Sugiyama Daisuke
• Secondary Sponsor: Jin Zhuan