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1.
Med Eng Phys ; 123: 104094, 2024 01.
Artigo em Inglês | MEDLINE | ID: mdl-38365334

RESUMO

Medical interventions have significantly progressed in developing minimally invasive techniques like percutaneous procedures. These procedures include biopsy and internal radiation therapy, where a needle or needle-like medical device is inserted through the skin to access a target inside the body. Ensuring accurate needle insertion and minimizing tissue-damage or cracks are critical in these procedures. This research aims to examine the coated needle effect on the force required to insert the needle (i.e., insertion force) and on tissue-damage during needle insertion into the bovine kidney. Reducing the needle insertion force, which is influenced by needle surface friction, generally results in a reduction in tissue-damage. Surgical needles were coated with a composite material, combining Polytetrafluoroethylene, Polydopamine, and Activated Carbon. Force measurement during needle insertion and a histological study to determine tissue-damage were conducted to evaluate the effectiveness of the coating. The insertion force was reduced by 49 % in the case of the coated needles. Furthermore, a histological analysis comparing tissue-damage resulting from coated and uncoated needles revealed an average 39 % reduction in tissue-damage with the use of coated needles. The results of this study demonstrate the potential of coated needles to enhance needle insertion and safety during percutaneous procedures.


Assuntos
Rim , Agulhas , Animais , Bovinos , Agulhas/efeitos adversos , Fricção , Pele
2.
BMC Oral Health ; 24(1): 265, 2024 Feb 23.
Artigo em Inglês | MEDLINE | ID: mdl-38389070

RESUMO

BACKGROUND: Dental anxiety is very much common among the patients and could be due to different factors like the behavior of the dentist, past experiences, Needle phobia, or word of mouth from other patients. According to recent studies, a strong association between sound and anxiety has been found, so this observational study has been conducted to find out the link between the activation of anxiety with the sound of a handpiece between experienced patients, who have already gone through the dental treatments and non-experienced patients. METHODS: Total of 297 participants were part of this study. These participants were divided into 2 groups according to the experienced and non-experienced dental patients. The researcher first filled out the CORAH Dental Anxiety Scale (DAS) form to mark the anxiety level of the patients, and then noted the readings of the heart rate in 3 intervals which were before during, and after the treatment with the pulse oximeter. Later the data was analysed using the SPSS independent t-test. RESULTS: Results show that patients in group 1 who have gone through the dental treatment before were less anxious and had a lesser effect on their heart rate than the patient who were having the treatment for the first time who were in group 2. Another interesting factor was noticed that in both the groups female were found to be more anxious than male participants. Participants with younger age were found to be more anxious than older age patient in both groups CONCLUSIONS: The sound of the handpiece can provoke anxiety in the patient, affecting the heart and increasing the heart rate. Participants who were experienced were found to be less anxious than the participants who were inexperienced.


Assuntos
Ansiedade ao Tratamento Odontológico , Transtornos Fóbicos , Som , Feminino , Humanos , Masculino , Ansiedade ao Tratamento Odontológico/etiologia , Ansiedade ao Tratamento Odontológico/fisiopatologia , Ansiedade ao Tratamento Odontológico/psicologia , Frequência Cardíaca , Transtornos Fóbicos/etiologia , Transtornos Fóbicos/fisiopatologia , Transtornos Fóbicos/psicologia , Som/efeitos adversos , Agulhas/efeitos adversos
3.
J Cardiothorac Surg ; 19(1): 101, 2024 Feb 19.
Artigo em Inglês | MEDLINE | ID: mdl-38374106

RESUMO

BACKGROUND: Acupuncture, a traditional Chinese medical treatment, has been gaining popularity over the years. However, it also presents certain risks. We report a case of a patient who discovered a foreign body in their lung several years after undergoing acupuncture. CASE PRESENTATION: A middle-aged woman presented to our hospital with chest pain. An X-ray revealed a needle-like foreign body in the middle lobe of her right lung. The patient had previously undergone acupuncture treatment for local pain in her lower back and lower extremities many years prior. Based on the imaging findings and her medical history, we hypothesized that the foreign body in her lung was a result of a dislodged acupuncture needle. Through preoperative 3-dimensional reconstruction and indocyanine green localization, we were able to locate the foreign body in the lateral segment of the right middle lobe. We successfully removed the foreign body via wedge resection, and the patient made a smooth recovery post-surgery. CONCLUSION: Acupuncturists and surgeons should remain vigilant about the potential risks associated with acupuncture.


Assuntos
Terapia por Acupuntura , Corpos Estranhos , Migração de Corpo Estranho , Humanos , Pessoa de Meia-Idade , Feminino , Agulhas/efeitos adversos , Terapia por Acupuntura/efeitos adversos , Corpos Estranhos/diagnóstico por imagem , Corpos Estranhos/etiologia , Corpos Estranhos/cirurgia , Radiografia , Dor no Peito , Migração de Corpo Estranho/diagnóstico por imagem , Migração de Corpo Estranho/etiologia
4.
J Cosmet Dermatol ; 23(5): 1560-1572, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38239003

RESUMO

OBJECTIVE: To provide dermatologists with more clinical experience in treating androgenetic alopecia, we evaluated the effect and safety of combined microneedling therapy for androgenetic alopecia. METHODS: Studies on combined microneedling for hair loss were comprehensively searched by us in PubMed, Excerpta Medica Database, and the Cochrane Library Database. The literature search spanned the period from 2012 to 2022. Inclusion and exclusion criteria were developed, and the literature was screened according to this criteria. The Cochrane Risk of Bias Tool was used to assess the quality of the studies. The researcher applied Revman 5.3 and Stata 15.1 software to analyze the data after extracting information from the data. RESULTS: Finally, 13 RCTs involving 696 AGA patients were included to compare the clinical effectiveness and adverse events of combined MN therapy with single MN therapy or single drug therapy for AGA. The results of meta-analysis showed as follows: (1) Hair density and diameter changes: The combined MN group was significantly better than any single treatment group, and the differences were statistically significant (MD = 13.36, 95% CI = [8.55, 18.16], Z = 5.45, p < 0.00001; MD = 18.11, 95% CI = [13.70, 22.52], Z = 8.04, p < 0.00001; MD = 13.36, 95% CI = [8.55, 18.16], Z = 5.45, p < 0.00001; MD = 2.50, 95% CI = [0.99, 4.02], Z = 3.23, p = 0.001); (2) the evaluation of satisfaction for efficacy: The doctor satisfaction rating of the combined MN group was significantly higher than that of any single treatment group, with statistical difference (RR = 2.03, 95% CI = [1.62, 2.53], Z = 6.24, p < 0.00001). The difference between the two groups regarding patients satisfaction was not significant (RR = 3.44, 95% CI = [0.67, 17.59], Z = 1.49, p = 0.14). (3) Safety: There was no statistical difference in the incidence of adverse reactions between combination therapy and monotherapy (RR = 0.83, 95% CI = [0.62, 1.12], Z = 1.22, p = 0.22). CONCLUSION: The combined MN group showed statistically significant improvement in hair density and diameter, and good safety compared with monotherapy.


Assuntos
Alopecia , Agulhas , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Alopecia/terapia , Agulhas/efeitos adversos , Resultado do Tratamento , Terapia Combinada/efeitos adversos , Terapia Combinada/métodos , Cabelo/crescimento & desenvolvimento , Técnicas Cosméticas/efeitos adversos , Técnicas Cosméticas/instrumentação , Agulhamento Seco/efeitos adversos , Agulhamento Seco/métodos , Satisfação do Paciente , 60575
5.
J Cosmet Dermatol ; 23(5): 1654-1662, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38284129

RESUMO

BACKGROUND: Rosacea is a prevalent chronic dermatological condition marked by facial inflammation and erythema, significantly compromising the quality of life for affected individuals. Current treatment methods for rosacea are not considered ideal because of the complex etiology of the disease. Mussel adhesive protein (MAP) is a glycoprotein derived from the foot gland of mussels. The protein exhibits anti-inflammatory properties, relieves skin itching, and promotes wound healing. AIMS: We aimed to explore the feasibility of using MAP administered via microneedle delivery for treating rosacea and the potential molecular mechanism involved. MATERIALS AND METHODS: The therapeutic effect and mechanism of MAP microneedle delivery in an LL-37-induced rosacea-like mouse model were observed using morphological and histological methods. Twenty-seven patients with erythematotelangiectatic rosacea (ETR) underwent treatment once every 1 month, with three treatments constituting one treatment course. The therapeutic effect was evaluated by comparing the clinical images taken at baseline, after the first treatment course, and after the second treatment course. The red value, CEA, and GFSS score were also calculated. RESULTS: In response to the microneedle delivery of MAP, innate immunity, inflammatory infiltration, and abnormal neurovascular regulation improved significantly in rosacea-like mice. In the clinical experiments, the microneedle delivery of MAP significantly improved the symptoms of erythema, flushing, and telangiectasia in patients with ETR, and no obvious adverse reactions were observed. CONCLUSIONS: MAP delivered by microneedling is effective and safe for treating ETR.


Assuntos
Agulhas , Rosácea , Rosácea/terapia , Animais , Humanos , Feminino , Camundongos , Pessoa de Meia-Idade , Adulto , Agulhas/efeitos adversos , Masculino , Modelos Animais de Doenças , Proteínas/administração & dosagem , Resultado do Tratamento , Estudos de Viabilidade , Pele/patologia , Administração Cutânea , Eritema/etiologia , Eritema/terapia , Catelicidinas , 60575
6.
Radiology ; 310(1): e230453, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-38259204

RESUMO

Background Splenic biopsy is rarely performed because of the perceived risk of hemorrhagic complications. Purpose To evaluate the safety of large bore (≥18 gauge) image-guided splenic biopsy. Materials and Methods This retrospective study included consecutive adult patients who underwent US- or CT-guided splenic biopsy between March 2001 and March 2022 at eight academic institutions in the United States. Biopsies were performed with needles that were 18 gauge or larger, with a comparison group of biopsies with needles smaller than 18 gauge. The primary outcome was significant bleeding after the procedure, defined by the presence of bleeding at CT performed within 30 days or angiography and/or surgery performed to manage the bleeding. Categorical variables were compared using the χ2 test and medians were compared using the Mann-Whitney test. Results A total of 239 patients (median age, 63 years; IQR, 50-71 years; 116 of 239 [48.5%] female patients) underwent splenic biopsy with an 18-gauge or smaller needle and 139 patients (median age, 58 years [IQR, 49-69 years]; 66 of 139 [47.5%] female patients) underwent biopsy with a needle larger than 18 gauge. Bleeding was detected in 20 of 239 (8.4%) patients in the 18-gauge or smaller group and 11 of 139 (7.9%) in the larger than 18-gauge group. Bleeding was treated in five of 239 (2.1%) patients in the 18-gauge or smaller group and one of 139 (1%) in the larger than 18-gauge group. No deaths related to the biopsy procedure were recorded during the study period. Patients with bleeding after biopsy had smaller lesions compared with patients without bleeding (median, 2.1 cm [IQR, 1.6-5.4 cm] vs 3.5 cm [IQR, 2-6.8 cm], respectively; P = .03). Patients with a history of lymphoma or leukemia showed a lower incidence of bleeding than patients without this history (three of 90 [3%] vs 28 of 288 [9.7%], respectively; P = .05). Conclusion Bleeding after splenic biopsy with a needle 18 gauge or larger was similar to biopsy with a needle smaller than 18 gauge and seen in 8% of procedures overall, with 2% overall requiring treatment. © RSNA, 2024 Supplemental material is available for this article. See also the editorial by Grant in this issue.


Assuntos
Biópsia Guiada por Imagem , Agulhas , Baço , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Angiografia , Biópsia Guiada por Imagem/efeitos adversos , Agulhas/efeitos adversos , Agulhas/estatística & dados numéricos , Estudos Retrospectivos , Baço/diagnóstico por imagem , Baço/patologia , Idoso
7.
Plast Reconstr Surg ; 153(2): 326e-330e, 2024 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-37010461

RESUMO

SUMMARY: The incidence of vascular occlusion injuries has risen substantially along with the increasing popularity of cosmetic injectables. Among these occurrences, instances of soft-tissue ischemic events following the injection of nonparticulate solutions, such as botulinum, represent an enigmatic etiology that has yet to be fully understood. One hypothesized mechanism of injury underlying these events relates to the accidental capture and intravascular ejection of needle microcores, defined as submillimeter tissue fragments trapped by the beveled lumen of a needle during conventional injections. To test this hypothesis, the authors conducted a cytologic evaluation of dermal remnants incidentally captured by 31-G tuberculin needles following repeated injections into postrhytidectomy skin fragments. Their findings revealed the presence of dermal tissue microcores ranging from 100 to 275 µm in diameter with an overall microcoring incidence of 0.7%. These findings confirm the ability of ultrafine needles, commonly used in botulinum injections, to produce tissue microcores that may serve as causative agents of vascular occlusion with nonparticulate solutions. Awareness of this mechanism of injury may be of benefit in the early recognition and management of these rare occurrences. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, V.


Assuntos
Doenças Vasculares , Lesões do Sistema Vascular , Humanos , Injeções , Agulhas/efeitos adversos , Pele
9.
Eur J Pharm Biopharm ; 195: 114148, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37995878

RESUMO

Skin-related immune disorders are a category of diseases that lead to the dysregulation of the body's immune response due to imbalanced immune regulation. These disorders exhibit diverse clinical manifestations and complicated pathogenesis. The long-term use of corticosteroids, anti-inflammatory drugs, and immunosuppressants as traditional treatment methods for skin-related immune disorders frequently leads to adverse reactions in patients. In addition, the effect of external preparations is not ideal in some cases due to the compacted barrier function of the stratum corneum (SC). Microneedles (MNs) are novel transdermal drug delivery systems that have theapparent advantages ofpenetrating the skin barrier, such as long-term and controlled drug delivery, less systemic exposure, and painless and minimally invasive targeted delivery. These advantages make it a good candidate formulation for the treatment of skin-related immune disorders and a hotspot for research in this field. This paper updates the classification, preparation, evaluation strategies, materials, and related applications of five types of MNs. Specific information, including the mechanical properties, dimensions, stability, and in vitro and in vivo evaluations of MNs in the treatment of skin-related immune disorders, is also discussed. This review provides an overview of the advances and applications of MNs in the effective treatment of skin-related immune disorders and their emerging trends.


Assuntos
Agulhas , Pele , Humanos , Agulhas/efeitos adversos , Administração Cutânea , Sistemas de Liberação de Medicamentos/métodos , Epiderme , Microinjeções/métodos
10.
Parkinsonism Relat Disord ; 118: 105950, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-38081119

RESUMO

INTRODUCTION: Botulinum toxin type A (BoNT/A) injections are the first-line treatment for primary hemifacial spasms (HFS), but require frequent painful injections. Although micro-hypodermic needles are commonly used for aesthetic BoNT/A injections to lessen pain and bruising, their benefits in HFS remain unclear. OBJECTIVE: To compare side effects of BoNT/A injection, specifically pain and bruising, between primary HFS patients who received injections using micro-hypodermic needles (34-G) and those using standard needles (30-G). METHODS: This cross-over, double-blind, randomised controlled trial involved HFS patients who received BoNT/A injections using either a 34-G or 30-G needle at two visits 12 weeks apart. Primary outcomes, pain and bruising were assessed immediately after injection using the Visual Analogue Scale (VAS) and Short-form McGill Pain Questionnaire (Thai version, SF-MPQ). Bruise assessment was also conducted one week after each injection. Secondary outcomes involved comparing efficacy of BoNT/A between the two types of needles and assessing other complications beyond pain and bruising. RESULTS: 65 HFS patients (47 women and 18 men; mean age 59.46 ± 11.48 years; mean disease duration 5.86 ± 4.16 years) were included in the study. Patients who received 34-G needle injections reported significantly reduced pain, as indicated by VAS, total SF-MPQ scores, and bruise scores, compared to those who received 30-G needle injections (p < 0.001, each). There were no differences in efficacy or occurrence of other complications associated with BoNT/A between the two needle types. CONCLUSION: In HFS patients, BoNT/A injections using micro-hypodermic needles resulted in reduced pain and bruising, compared to standard needles, while maintaining similar BoNT/A benefits.


Assuntos
Toxinas Botulínicas Tipo A , Contusões , Espasmo Hemifacial , Fármacos Neuromusculares , Masculino , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Espasmo Hemifacial/tratamento farmacológico , Espasmo Hemifacial/complicações , Agulhas/efeitos adversos , Dor/etiologia , Contusões/induzido quimicamente , Contusões/complicações , Contusões/tratamento farmacológico , Resultado do Tratamento
11.
J Drugs Dermatol ; 22(12): e47-e48, 2023 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-38051834

RESUMO

Calcinosis cutis can occur idiopathically or be associated with injury, metabolic disease, and different rheumatologic diseases such as scleroderma and dermatomyositis. Calcinosis cutis is often treatment-resistant and leads to decreased quality of life and pain. Medical therapies, such as bisphosphonates, warfarin, tetracyclines, calcium channel blockers, colchicine, laser therapy and surgery, lithotripsy, and even stem cell transplantation have been used with varying success.1 Lesions of calcinosis cutis can persist even when systemic disease is adequately controlled leaving the patient with a painful reminder of their underlying disease.


Assuntos
Calcinose Cutânea , Dermatopatias , Humanos , Agulhas/efeitos adversos , Dermatopatias/diagnóstico , Dermatopatias/etiologia
12.
Tex Heart Inst J ; 50(6)2023 12 07.
Artigo em Inglês | MEDLINE | ID: mdl-38087478

RESUMO

Endoscopic ultrasonography-guided transesophageal pericardiocentesis was performed for a posteriorly located effusion not amenable to transthoracic drainage in a 58-year-old woman with a history of recurrent breast adenocarcinoma who presented with dyspnea. The patient had a pericardial effusion that resulted in cardiac tamponade. Transthoracic pericardiocentesis was unsuitable because of the posterior location of the effusion. Pericardiocentesis via the transesophageal route was performed. The pericardial sac was punctured with a 19-gauge needle, and 245 mL of pericardial fluid were aspirated, resulting in the resolution of the tamponade physiology. Endoscopic ultrasonography-guided transesophageal drainage is a novel and promising therapeutic option for posteriorly located pericardial effusions.


Assuntos
Tamponamento Cardíaco , Derrame Pericárdico , Feminino , Humanos , Pessoa de Meia-Idade , Derrame Pericárdico/diagnóstico , Derrame Pericárdico/etiologia , Derrame Pericárdico/terapia , Pericardiocentese/métodos , Tamponamento Cardíaco/diagnóstico , Tamponamento Cardíaco/etiologia , Tamponamento Cardíaco/cirurgia , Pericárdio , Agulhas/efeitos adversos
14.
Niger J Clin Pract ; 26(10): 1588-1590, 2023 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-37929541

RESUMO

Foreign bodies in the urethra can occur by self-insertion, and patients often hide the symptoms due to embarrassment. Foreign bodies act as a focus for infection and abscess formation and result in perforation or fistula when not detected on time. Foreign bodies can display symptoms such as frequent urination, dysuria, hematuria, urethrorrhagia, and obstruction. This case discusses a self-inserted urethral sewing needle that was removed cystoscopically from an adolescent.


Assuntos
Corpos Estranhos , Uretra , Adolescente , Humanos , Uretra/cirurgia , Corpos Estranhos/complicações , Corpos Estranhos/diagnóstico por imagem , Corpos Estranhos/cirurgia , Agulhas/efeitos adversos
15.
J Vis Exp ; (199)2023 09 22.
Artigo em Inglês | MEDLINE | ID: mdl-37811932

RESUMO

The objective of this study is to observe the effect of indwelling needle puncture and irrigation in the conservative treatment of breast abscesses in the non-lactation period. Non-lactating breast abscess patients were treated at the Daping Medical Breast Surgery Clinic, Chongqing. In the Incisive drainage group, 21 patients were treated with conventional incision and drainage. In the Indwelling needle group, 20 patients were treated by puncture and irrigation with a 20 G indwelling needle. The pain VAS scores and wound satisfaction in the Indwelling needle group were significantly lower than those in the Incisive drainage group (P < 0.001), and the cure time and complications were also significantly lower in the Indwelling needle group (P < 0.05). The cure rates of the two groups were similar (P > 0.05). There was a difference in the duration of illness, location, and number of pus cavities between the treatment failure and the treatment recovery (P < 0.05). However, there was no difference in the size of the pus cavity and the maximum amount of pus aspiration (P > 0.05). The indwelling needle can be used as an effective tool for puncture and irrigation of single breast abscess in a non-lactation period, potentially for non-invasive treatment of breast abscesses.


Assuntos
Abscesso , Ferida Cirúrgica , Humanos , Abscesso/terapia , Abscesso/cirurgia , Tratamento Conservador/efeitos adversos , Agulhas/efeitos adversos , Punções/efeitos adversos
16.
Dermatol Surg ; 49(10): 938-942, 2023 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-37584506

RESUMO

BACKGROUND: Acne scars cause significant psychosocial stress. Despite a wide armamentarium, there is a constant search for an effective modality. Autologous injectable platelet-rich fibrin (i-PRF) is a promising novel option in the management of atrophic scars. OBJECTIVE: To compare efficacy of autologous i-PRF with microneedling against microneedling alone in atrophic acne scars. MATERIALS AND METHODS: A split-face prospective interventional study was conducted on 40 patients with atrophic acne scars. Autologous i-PRF and normal saline were injected into each scar on right (study) and left (control) sides, respectively, followed by microneedling on both sides. Four sessions were performed at monthly intervals with follow-up at 2 months. For assessment, Goodman and Baron (GB) scale, physician subjective score, and patient satisfaction scores were used. RESULTS: Mean baseline GB grade on each side was 3.45. At 24 weeks, mean GB grade was significantly reduced on the study side (1.47, SD 0.56) than control side (3.33, SD 0.53). Mean patient satisfaction score was significantly higher on the right side (5.95) compared with the left side (5.35). Rolling scars responded the best followed by boxcar and ice-pick scars. CONCLUSION: Autologous i-PRF and microneedling act synergistically to improve acne scars.


Assuntos
Acne Vulgar , Doenças do Tecido Conjuntivo , Técnicas Cosméticas , Fibrina Rica em Plaquetas , Plasma Rico em Plaquetas , Humanos , Acne Vulgar/complicações , Acne Vulgar/terapia , Atrofia/complicações , Cicatriz/etiologia , Cicatriz/terapia , Cicatriz/patologia , Doenças do Tecido Conjuntivo/complicações , Técnicas Cosméticas/efeitos adversos , Agulhas/efeitos adversos , Estudos Prospectivos , Solução Salina , Resultado do Tratamento
18.
Sensors (Basel) ; 23(13)2023 Jun 30.
Artigo em Inglês | MEDLINE | ID: mdl-37447917

RESUMO

Lumbar puncture is a minimally invasive procedure that utilizes a spinal needle to puncture the lumbar epidural space to take a sample from the cerebrospinal fluid or inject drugs for diagnostic and therapeutic purposes. Physicians rely on their expertise to localize epidural space. Due to its critical procedure, the failure rate can reach up to 28%. Hence, a high level of experience and caution is required to correctly insert the needle without puncturing the dura mater, which is a fibrous layer protecting the spinal cord. Failure of spinal anesthesia is, in some cases, related to faulty needle placement techniques since it is blindly inserted. Therefore, advanced techniques for localization of the epidural space are essential to avoid any possible side effects. As for epidural space localization, various ideas were carried out over recent years to provide accurate identification of the epidural space. Subsequently, several methodologies based on mechanical and optical schemes have been proposed. Several research groups worked from different aspects of the problem, namely, the clinical and engineering sides. Hence, the main goal of this paper is to review this research with the aim of remedying the gap between the clinical side of the problem and the engineering side by examining the main techniques in building sensors for such purposes. This manuscript provides an understanding of the clinical needs of spinal needles from an anatomical point of view. Most importantly, it discusses the mechanical and optical approaches in designing and building sensors to guide spinal needles. Finally, the standards that must be followed in building smart spinal needles for approval procedures are also presented, along with some insight into future directions.


Assuntos
Anestesia Epidural , Raquianestesia , Agulhas/efeitos adversos , Punção Espinal/efeitos adversos , Punção Espinal/métodos , Raquianestesia/efeitos adversos , Raquianestesia/métodos , Sistema Nervoso Central
19.
Trials ; 24(1): 464, 2023 Jul 21.
Artigo em Inglês | MEDLINE | ID: mdl-37475006

RESUMO

BACKGROUND: Acute lymphoblastic leukemia (ALL) is the most common malignancy diagnosed in children. At present, the long-term survival from pediatric ALL is well over 90%. However, the probability of event-free survival is reduced if the lumbar puncture (LP) procedures at the beginning of the patient's intrathecal therapy cause blood leakage into the spinal canal and blast cells contaminate the cerebrospinal fluid. According to the literature, such traumatic LP procedures concern one out of five pediatric patients with ALL. Recently, a novel medical device measuring the tissue bioimpedance at the tip of a spinal needle was found feasible in pediatric patients with ALL. The LP procedure was successful at the first attempt in 80% of procedures, and the incidence of traumatic LPs was then 11%. The purpose of the present study is to compare the bioimpedance spinal needle system with the standard clinical practice resting on a conventional spinal needle and investigate its efficacy in clinical practice. METHODS: The study is a multicenter, randomized, two-arm crossover noninferiority trial of pediatric hemato-oncology patients that will be conducted within the usual clinical workflow. Patients' LP procedures will be performed alternately either with the IQ-Tip system (study arm A) or a conventional Quincke-type 22G spinal needle (study arm B). For each enrolled patient, the order of procedures is randomly assigned either as ABAB or BABA. The total number of LP procedures will be at least 300, and the number of procedures per patient between two and four. After each study LP procedure, the performance will be recorded immediately, and 1-week diary-based and 4-week record-based follow-ups on symptoms, complications, and adverse events will be conducted thereafter. The main outcomes are the incidence of traumatic LP, first puncture success rate, and incidence of post-dural puncture headache. DISCUSSION: The present study will provide sound scientific evidence on the clinical benefit, performance, and safety of the novel bioimpedance spinal needle compared with the standard clinical practice of using conventional spinal needles in the LP procedures of pediatric patients with leukemia. TRIAL REGISTRATION: ISRCTN ISRCTN16161453. Registered on 8 July 2022.


Assuntos
Leucemia , Cefaleia Pós-Punção Dural , Humanos , Criança , Punção Espinal/efeitos adversos , Punção Espinal/métodos , Agulhas/efeitos adversos , Estudos Cross-Over , Cefaleia Pós-Punção Dural/etiologia , Leucemia/terapia , Leucemia/complicações , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como Assunto
20.
Sci Rep ; 13(1): 9667, 2023 06 14.
Artigo em Inglês | MEDLINE | ID: mdl-37316637

RESUMO

Around one-third of adults are scared of needles, which can result in adverse emotional and physical responses such as dizziness and fainting (e.g. vasovagal reactions; VVR) and consequently, avoidance of healthcare, treatments, and immunizations. Unfortunately, most people are not aware of vasovagal reactions until they escalate, at which time it is too late to intervene. This study aims to investigate whether facial temperature profiles measured in the waiting room, prior to a blood donation, can be used to classify who will and will not experience VVR during the donation. Average temperature profiles from six facial regions were extracted from pre-donation recordings of 193 blood donors, and machine learning was used to classify whether a donor would experience low or high levels of VVR during the donation. An XGBoost classifier was able to classify vasovagal groups from an adverse reaction during a blood donation based on this early facial temperature data, with a sensitivity of 0.87, specificity of 0.84, F1 score of 0.86, and PR-AUC of 0.93. Temperature fluctuations in the area under the nose, chin and forehead have the highest predictive value. This study is the first to demonstrate that it is possible to classify vasovagal responses during a blood donation using temperature profiles.


Assuntos
Agulhas , Síncope Vasovagal , Adulto , Humanos , Agulhas/efeitos adversos , Temperatura , Síncope Vasovagal/etiologia , Síncope , Vertigem
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