• Title/Summary/Keyword: clinical device

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Aerosol protection using modified N95 respirator during upper gastrointestinal endoscopy: a randomized controlled trial

  • Chawisa Nampoolsuksan;Thawatchai Akaraviputh;Asada Methasate;Jirawat Swangsri;Atthaphorn Trakarnsanga;Chainarong Phalanusitthepha;Thammawat Parakonthun;Voraboot Taweerutchana;Nicha Srisuworanan;Tharathorn Suwatthanarak;Thikhamporn Tawantanakorn;Varut Lohsiriwat;Vitoon Chinswangwatanakul
    • Clinical Endoscopy
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    • v.57 no.3
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    • pp.335-341
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    • 2024
  • Background/Aims: The coronavirus disease 2019 pandemic has affected the worldwide practice of upper gastrointestinal endoscopy. Here we designed a modified N95 respirator with a channel for endoscope insertion and evaluated its efficacy in upper gastrointestinal endoscopy. Methods: Thirty patients scheduled for upper gastrointestinal endoscopy were randomized into the modified N95 (n=15) or control (n=15) group. The mask was placed on the patient after anesthesia administration and particles were counted every minute before (baseline) and during the procedure by a TSI AeroTrak particle counter (9306-04; TSI Inc.) and categorized by size (0.3, 0.5, 1, 3, 5, and 10 ㎛). Differences in particle counts between time points were recorded. Results: During the procedure, the modified N95 group displayed significantly smaller overall particle sizes than the control group (median [interquartile range], 231 [54-385] vs. 579 [213-1,379]×103/m3; p=0.056). However, the intervention group had a significant decrease in 0.3-㎛ particles (68 [-25 to 185] vs. 242 [72-588] ×103/m3; p=0.045). No adverse events occurred in either group. The device did not cause any inconvenience to the endoscopists or patients. Conclusions: This modified N95 respirator reduced the number of particles, especially 0.3-㎛ particles, generated during upper gastrointestinal endoscopy.

Cryoballoon Catheter Ablation in Korean Patients With Paroxysmal and Persistent Atrial Fibrillation: One Year Outcome From the Cryo Global Registry

  • Hong Euy Lim;Il-Young Oh;Fred J Kueffer;Kelly Anna van Bragt;Young Keun On
    • Korean Circulation Journal
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    • v.52 no.10
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    • pp.755-767
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    • 2022
  • Background and Objectives: Cryoballoon catheter ablation for the treatment of patients with symptomatic atrial fibrillation (AF) has been adopted globally, but there are limited multicenter reports of 12-month outcomes in the Korean patient population. This analysis evaluated the clinical performance and safety of cryoballoon ablation (CBA) according to standard-of-care practices in Korea. Methods: This evaluation of Korean patients with AF was conducted within the larger Cryo Global Registry, which is a prospective, multicenter, post-market registry. Freedom from a ≥30-second recurrence of atrial arrhythmias (after a 90-day blanking period until 12 months) and procedural safety were examined in subjects treated with CBA at 3 Korean centers. Results: Overall, 299 patients with AF (60±11 years old, 24.7% female, 50.5% paroxysmal AF) underwent CBA using the Arctic Front Advance cryoballoon. Of those, 298 were followed-up for at least 12 months. Mean procedure-, left atrial dwell- and fluoroscopy time was 76±21 minutes, 56±23 minutes, and 27±23 minutes, respectively. Freedom from AF recurrence at 12 months was 83.9% (95% confidence interval [CI], 76.9-88.9%) in the paroxysmal and 61.6% (95% CI, 53.1-69.0%) in the persistent AF cohort. Rhythm monitoring was performed on average 4.7±1.4 times during the follow-up period. Serious device- or procedure-related adverse events occurred in 2 patients (0.7%). The 12-month Kaplan-Meier estimate of freedom from repeat ablation and cardiovascular-related hospitalization was 93.8% (95% CI, 90.4-96.1%) and 89.7% (95% CI, 85.6-92.7%), respectively. Conclusions: CBA is an efficient, effective, and safe procedure for the treatment of AF patients when used according to real-world practices in Korea.

A comparison between the modified Brostrom procedure using single and double suture anchor for chronic lateral ankle instability (발목관절 외측 불안정성에서 단일 봉합나사와 이중 봉합나사를 이용한 변형 Brostrom 술식간의 임상결과 비교)

  • Shon, Hyun-Chul;Cho, Byung-Ki;Kim, Yong-Min;Kim, Dong-Soo;Choi, Eui-Sung;Park, Kyoung-Jin;Park, Ji-Kang
    • Journal of Korean Orthopaedic Sports Medicine
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    • v.10 no.2
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    • pp.69-77
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    • 2011
  • Purpose: This study was retrospectively performed to compare the clinical outcomes of modified Brostrom procedures using the single suture anchor and the double suture anchor for chronic lateral ankle instability. Materials and Methods: Thirty-seven patients were followed up for more than 1 year after the modified Brostrom procedures using suture anchor. Single surgeon treated seventeen cases with single suture anchor and 20 cases with double suture anchor. The clinical evaluation was performed according to the Karlsson scale and Sefton grading system. Radiologic measurement of the talar tilt and anterior talar translation was performed through anterior and varus stress radiographs using Telos device. Results: The Karlsson scale had improved significantly from preoperative average of 45.2 points to 89.4 points in single suture anchor group, and from 46.4 points to 90.5 points in double suture anchor group. According to the Sefton grading system, 15 cases (88.2%) in single suture anchor group and 18 cases (90%) in double suture anchor group achieved satisfactory results. The talar tilt angle and anterior talar translation had improved significantly from preoperative average of $13.6^{\circ}$ and 8.6 mm to $5.4^{\circ}$ and 4.1 mm in single suture anchor group, from $14.1^{\circ}$ and 8.4mm to $3.9^{\circ}$ and 4 mm in double suture anchor group. Double suture anchor technique was significantly superior in postoperative talar tilt. Conclusion: Single and double suture anchor techniques produced similar clinical and functional outcomes except for talar tilt, which was significantly superior in double suture anchor group. Both modified Brostrom procedures using the single and double suture anchor appear to be effective treatment methods for chronic lateral ankle instability. Further evaluation of clinical outcomes and biomechanical studies in athletes are needed.

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ACL reconstruction with autologous hamstring tendon - Short term clinical result using new femoral suspensory fixation device 'Cross Pin' and graft tensioner for maintaining a constant tension- (자가 슬괵건을 이용한 전방 십자 인대 재건술 - 새로운 대퇴부 현수고정법인 Cross Pin과 일정한 긴장력 유지를 위한 Graft Tensioner 사용의 단기 추시 결과 -)

  • Seo, Seung-Suk;Kim, Chang-Wan;Kim, Jin-Seok;Choi, Sang-Yeong
    • Journal of Korean Orthopaedic Sports Medicine
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    • v.10 no.1
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    • pp.27-34
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    • 2011
  • Purpose: To evaluate the short term clinical result of ACL reconstruction with autologous hamstring tendon using Cross pin and Graft Tensioner and to seek way to resolve the experienced technical problems. Materials and Methods: From January 2008 to March 2009, 35 patients who had been treated arthroscopic ACL reconstruction were enrolled. The femoral side of ACL graft was fixed with Cross pin. The tibial side of graft was fixed with Intrafix and post-tie. The graft was tensioned with Graft Tensioner at 80N. We analyzed the clinical, radiographic results and complications. Results: IKDC subjective score and Lysholm score improved to 89.1 and 91.4 points. Also, Pivot shift test and One-leg hop test showed good results postoperatively. Side to side difference using KT-1000 arthrometer and Telos stress radiography improved compared with normal limb to $2.8{\pm}1.6$ mm and $2.6{\pm}1.3$ mm, respectively. The femoral tunnel enlarged to $2.3{\pm}1.1$ mm. Soft tissue irritation and femoral tunnel-graft harness length mismatch, femoral tunnel-cross pin tunnel mismatch were happened as peri-operative complications. Conclusion: Using of Cross pin and Graft Tensioner for ACL reconstruction with hamstring tendon is one of the good method for obtaining stability in short-term clinical result. But to reduce femoral tunnel-cross pin mismatch, it needs to shorten femoral bone tunnel and to create cross pin tunnel as vertical as possible. And to reduce femoral tunnel-graft harness mismatch, it needs to advance position rod further 3 mm when to create femoral tunnel.

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Endoscopic Carpal Tunnel Release Using Single Portal Technique (단일 입구를 이용한 내시경적 수근관 감압술)

  • Cheon Sang-Jin;Kim Hui-Taek;Suh Kuen-Tak;Suh Jeung-Tak;Yoo Chong-Il
    • Journal of the Korean Arthroscopy Society
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    • v.4 no.2
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    • pp.159-165
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    • 2000
  • Purpose : Endoscopic carpal tunnel release technique was developed and has being used to decrease postoperative morbidity and complications. The purpose of this study was to evaluate the clinical results and clinical usefulness of endoscopic carpal tunnel release using single portal technique. Methods and Materials : 18 carpal tunnel syndrome patients who were diagnosed by means of clinical symptoms, physical examination, and electrodiagnostic study had endoscopic carpal tunnel release using single portal technique with about 1 cm oblique wrist incision on 30 hands. And then they were followed-up and reviewed in the same way. Late results of operation were analysed by grading system according to patient's own assessments of relief of symptoms at the final fellow-up. The follow-up period ranged 6 to 13 months from surgery. Results : There were postoperative improvements with respect to clinical symptoms, physical examination, and electrodiagnostic study. 23 of 30 hands$(76.7\%)$ had complete resolution of symptoms. 27 hands$(90\%)$ were able to return to normal activities and work within 6 weeks, and 30 hands$(100\%)$ returned within 8 weeks. In grip strength study, 29 hands$(96.6\%)$ regained preoperative strength in 6 months. 12 of 22 hands$(55\%)$ had improvement with respect to thenar atrophy within 6 months. Late results were as follows . 23 hands$(76.7\%)$ was graded as excellent, 6 hands$(20\%)$ graded as good and 1 hand$(3.3\%)$ graded as fair, and there was no poor result. Conclusion : We think that endoscopic carpal tunnel release with single portal technique is technically safe and simple, if the surgeon takes step to stay within the safety zone based on local anatomy and selects an appropriate patient and that endoscopic carpal tunnel release does have advantages over open release. We agree that the surgeon must be prepared to perform an open technique, if technical difficulties arise, difficulty in introducing the device into the carpal tunnel is encountered, or the transverse fibers of the transverse carpal ligaments are not clearly seen.

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Administration of Yijung-tang, Pyeongwi-san, and Shihosogan-tang for Standardization of Korean Medicine Pattern Identification for Functional Dyspepsia: A Study Protocol of a Randomized, Assessor-blind, 3-Arm, Parallel, Open-label, Multicenter Clinical Trial (기능성 소화불량 한의 변증 표준화를 위한 이중탕, 평위산 및 시호소간탕 투여 : 무작위 배정, 평가자 눈가림, 3군 비교, 평행 설계, 공개, 다기관 임상시험 프로토콜)

  • Boram Lee;Min-Jin Cho;Young-Eun Choi;Ojin Kwon;Mi Young Lim;Seok-Jae Ko;So-yeon Kim;Yongjoo Kim;Donghyun Nam;Dong-Jun Choi;Jun-Hwan Lee;Jae-Woo Park;Hojun Kim
    • The Journal of Internal Korean Medicine
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    • v.43 no.6
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    • pp.1105-1121
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    • 2022
  • Objectives: The purpose of this study is to explore the effectiveness and safety of frequently used clinical herbal medicines (Yijung-tang [Lizhong-tang, LJT], Pyeongwi-san [Pingwei-san, PWS], and Shihosogan-tang [Chaihu Shugan-tang, SST]) in patients with functional dyspepsia (FD) when administered according to herbal medicine and Korean medicine pattern identification. The results of this study will be used to standardize the diagnostic instrument used in Korean medicine and to investigate biomarkers of Korean medicine pattern identification. Methods: This study will be a randomized, assessor-blind, 3-arm, parallel, open-label, multi-center clinical trial. A total of 300 FD participants will be recruited from 3 Korean medical hospitals and assigned to the LJT (n=100), PWS (n=100), and SST (n=100) groups according to FD pattern identification. The patients will take the medication for 8 weeks, 3 times a day, before or between meals. The primary outcome will be total dyspepsia symptom (TDS) and the secondary outcomes will be adequate relief (AR) for dyspepsia, overall treatment effect (OTE), visual analogue scale (VAS), functional dyspepsia-related quality of life (FD-QoL), gastrointestinal symptom score (GIS), and pattern identification questionnaires. For the exploratory outcomes, we will analyze blood and fecal metabolome profiles, microbiota from fecal and saliva samples, single nucleotide polymorphism (SNP), and results of Korean medicine diagnosis device measurements (heart rate variability, and tongue, pulse, and abdominal diagnosis). Conclusions: The results of this study will prove objectivity for Korean medicine pattern identifications, and the effectiveness and safety of herbal medicines for the population with FD.

Reconstruction of Anterior Cruciate Ligament in Adolescent (청소년기에 시행한 전방십자인대 재건술)

  • Song Eun Kyoo;Shim Sang Don;Kim Hyung Jong;Kim Hyung Won
    • Journal of the Korean Arthroscopy Society
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    • v.6 no.2
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    • pp.101-108
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    • 2002
  • Purpose: To evaluate the clinical results of anterior cruciate ligament (ACL) reconstruction and to know the results of physeal injury by transphyseal tunnel in adolescents who had remaining growth potential. Materials and Methods : This study involved 12 patients under 19 years old out of 445 patients, who underwent ACL reconstruction between 1993 and 2001. The mean age at the time of operation was 15.9 $(13.1\~16.9)$ years and fellow-up period was 45.1 $(24\~120.6)$ months in avrarge. Autologous quadrupled hamstring tendon was used as graft in 11 cases and bone-patellar tendon-bone in 1 case. Clinical results were evaluated by Lysholm Knee Scoring Scale, range of motion and return to preinjury sports activities. Radiologic results were evaluated by $Telos^{\circledR}$ device. Bone maturity were analyzed by chronological age, standing height and the width of growth plate in AP and lateral view of knee joint at preoperatively. The growth disturbances were evaluated by measuring femorotibial angle, anatomical and mechanical lateral distal femoral angle, mechanical medial proximal tibial angle and leg length and by comparing those of uninjured site in last follow-up teleoroentgenogram. Results : The mean Lysholm Knee score was 51 $(25\~63)$points preoperatively and 98 $(94\~100)$ points at last follow up. The mean anterior displacement of the tibia by using $Telos^{\circledR}$ device was improved from 13.5 $(6\~27)$ mm to 2.9 $(1\~4)$ mm and there were no significant instabilities of the knee in all cases. There were no leg length discrepancies over 1 cm and no statistically significant abnormal alignment of the knee joint in all cases. Conclusion: ACL reconstruction using transphyseal tunnel for restoring stability and knee function is assumed as a good mettled of treatment without significant leg length discrepancy and abnormal alignment of the knee joint.

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A Dosimetric Evaluation of Large Pendulous Breast Irradiation in Prone Position (Large Pendulous Breast 환자의 방사선 치료에 있어서 엎드린 자세의 유용성 평가)

  • Hong, Chae-Seon;Ju, Sang-Gyu;Park, Ju-Young
    • The Journal of Korean Society for Radiation Therapy
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    • v.20 no.1
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    • pp.37-43
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    • 2008
  • Purpose: To evaluate dosimetry results of three different techniques for whole breast irradiation after conservative surgery of large pendulous breast patient. Materials and Methods: Planning computed tomography (CT) scans for three techniques were performed on a GE Hi-speed advantage CT scanner in the supine (SP), supine with breast supporting Device (SD) and prone position on a custom prone mattress (PP). Computed tomography images were acquired at 5 mm thickness. The clinical target volumes (CTV), ipsilateral lung and heart were delineated to evaluate the dose statistic, and all techniques were planned with the tangential photon beams (Pinnacle$^3$, Philips Medical System, USA). The prescribed dose was 50 Gy delivered in 25 fractions. To evaluate the dose coverage for CTV, we analysed percent volume of CTV receiving minimum of 95%, 100%, 105%, and 110% of prescription dose ($V_{95}$, $V_{100}$, $V_{105}$, and $V_{110}$) and minimal dose covering 95% ($D_{95}$) of CTV. The dosimetric comparison for heart and ipsilateral lung was analysed using the minimal dose covering 5% of each organs ($D_5$) and the volume that received >18 Gy for the heart and >20 Gy for the ipsilateral lung. Results: Target volume coverage ($V_{95}$ and $V_{100}$) was not significantly different for all technique. The V105 was lower for PP (1.2% vs. 4.4% for SP, 11.1% for SD). Minimal dose covering 95% ($D_{95}$) of target was 47.5 Gy, 47.7 Gy and 48 Gy for SP, SD and PP. The volume of ipsilateral lung received >20 Gy was 21.7%, 11.6% and 4.9% for SP, SD and PP. The volume of heart received >18 Gy was 17.0%, 16.1% and 9.8% for SP, SD and PP. Conclusion: Prone positioning of patient for large pendulous breast irradiation enables improving dose uniformity with minimal heart and lung doses.

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A Study on Central Vein Cannulation Using Audible Doppler Guidance in Children and Infants (Audible Doppler Ultrasound(8 MHz)를 이용한 소아와 영아에서 중심정맥 도관 삽입술에 관한 연구)

  • Ahn, Young Joon;Jung, Jin Young;Hong, Soo-Jong
    • Clinical and Experimental Pediatrics
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    • v.45 no.9
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    • pp.1120-1125
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    • 2002
  • Purpose : Percutaneous cannulation of the central vein in children and infants may be technically difficult and can cause serious complications. There are many techniques to improve the success rate and to decrease the complications in central vein cannulation. This study was undertaken to determine whether audible Doppler guidance can help operators improve the results of central vein cannultion in pediatric ICU. Methods : A total of 46 central vein cannulations were performed using audible Doppler guidance technique. Using an 8-MHz Doppler ultrasound device(Pocket-Dop II. iMex. USA), the artery and the vein were identified by their characteristic Doppler sounds. Results : There was a total of 46 patients with 20 boys and 26 girls, respectively. The mean age was $3years{\pm}45months$(range : 1-156 months). The number of infants was 18 and the mean age was $6.3{\pm}3.8$ months(range : 1-12 months). The most common site of central vein cannulation was the right internal jugular vein(63%). The cannulation was successful in 44 out of 46 procedures(96%). The success rate at the first attempt was 59% with 48% in the patients who had the history of previous cannulation and 70% in the patients who did not, respectively. The success rate in infants was 94%(17 out of 18). The average access time was $5.2{\pm}8.3$ minutes in children contrary to $7.5{\pm}10.3$ minutes in infants. There were no serious complications, but six patients had complications including four hematoma, one arterial puncture, and one pneumothorax. Conclusion : This central vein cannulation using Doppler guidance may improve the success rate of central vein cannulation and decrease the development of serious complications in infants and children.

Surgical Technique for Korean Artificial Heart(AnyHeart) Implantation Using a Right Thoracotomy Approach (우측 개흉술을 이용한 한국형 인공심장(AnyHeart)의 이식기법)

  • Son. Ho-Sung;Sun, Kyung;Shin, Jae-Seung;Lee, Sung-Ho;Jung, Jae-Seung;Lee, Hye-Won;Kim, Kwang-Taik;Kim, Seung-Chul;Won, Yong-Soon;Min, Byoung-Goo;Kim, Hyoung-Mook
    • Journal of Chest Surgery
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    • v.35 no.5
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    • pp.329-335
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    • 2002
  • Background: The surgical technique for biventricular assist device(BVAD) implantation has mainly consisted of cannulation procedures. A median sternotomy has been the technique of choice as it gives a surgeon an excellent exposure of the heart. However, considering that most patients require a future sternotomy or already have a previous sternotomy, sternotomy-related complication remains a major concern in BVAD implantation. Based on this consideration as well as the clinical experiences of conventional heart surgery, the authors have hypothesized that the cardiac chambers for BVAD cannulation can be approached from the right side of the heart. The purpose of this studs to develop a novel surgical technique of right thoracotomy for BVAD implantation in an animals study. Material and Method: For last two years, 16 (11 calves, 3 canines, and 2 sheep) out of 30 experimental animals with AnyHeart implantation underwent a right thoracotomy. The device was used as an implantable BVAD in 14 animals, a wearable BVAD in 1, and an implantable LVAD in 1. The chest cavity was entered through the 4th intercostal space or the 5th periosteal bed. As for the BVAD use, a right inflow cannula was inserted into the right atrial free wall and a right outflow cannula was grafted onto the main pulmonary artery. A left inflow cannula was inserted into the interatrial groove and a left outflow cannula was grafted on the innominate artery of the ascending aorta. The connecting tubes were brought out through the thoracotomy wound and connected to the pump located in the subcutaneous pocket at the right flank. Result: Except for the 5 animals for a lilting test or during the early learning curve, all recovered smoothly from the procedures. The inflow drainage allowed the pump output 6.5 L/min at the maximum with 3-3.5 L/min in an average. Of the survivors, there noted no procedure-related mortality or morbidity. Necropsy findings demonstrated the well-positioned cannula tips in the each cardiac chamber