Intubation, Gastrointestinal

插管,胃肠
  • 文章类型: Journal Article
    目的:这项工作研究了腹部紧身胸衣对结肠镜检查完成率的影响,以及盲肠和回肠插管时间,结肠镜检查总时间,中心性肥胖患者的疼痛评分。
    方法:患者随机分为两组,每组50名患者。使用第1组的腹部紧身胸衣和第2组的标准方法进行结肠镜检查。组间比较评估的人口统计数据,程序详细信息,循环动力学,麻醉数据,和视觉模拟量表(VAS)。
    结果:纳入研究的患者中,60是女性,40个是男性,平均年龄57.3±13.6岁。盲肠插管时间(Z:-2.66p:0.008),结肠镜检查总时间(Z:-2.180p:0.029),机动次数(χ2:8.391p:0.039),腹带组VAS(Z:-3.087p:0.002)明显降低。
    结论:应用腹部外压迫的腹部紧身胸衣减少了盲肠插管时间,结肠镜检查的总时间,演习的次数,和疼痛程度。
    背景:NCT03128645(https://clinicaltrials.gov/study/NCT03128645?tab=results)。
    OBJECTIVE: This work investigated the effect of an abdominal corset on the colonoscopy completion rate, as well as cecum and ileum intubation time, total colonoscopy time, and pain score in centrally obese patients.
    METHODS: Patients were randomized into two groups, with 50 patients in each group. A colonoscopy was performed using the abdominal corset in Group 1 and the standard method in Group 2. The comparison between the groups evaluated demographic data, procedure details, circulatory dynamics, anesthesia data, and visual analogue scale (VAS).
    RESULTS: Of the patients included in the study, 60 were female, and 40 were male, with a mean age of 57.3 ± 13.6 years. Cecal intubation time (Z: -2.66 p: 0.008), total colonoscopy time (Z: -2.180 p: 0.029), number of maneuvers (χ2: 8.391 p: 0.039), and VAS (Z: -3.087 p: 0.002) were significantly lower in the abdominal corset group.
    CONCLUSIONS: An abdominal corset that applies external abdominal compression reduces the cecal intubation time, the total colonoscopy time, the number of maneuvers, and the pain level.
    BACKGROUND: NCT03128645 (https://clinicaltrials.gov/study/NCT03128645?tab=results).
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  • 文章类型: Journal Article
    背景:重症监护病房(ICU)的患者极易营养不良,虽然通过鼻胃管进行肠内营养是首选方法,有无意的反流和误吸的风险。因此,临床医生已将鼻肠管(NET)作为肠内营养的替代选择。但是NET的精确定位提出了一个持续的挑战。我们提出了一种创新的方法,为参与NET放置的临床医生提供有价值的参考。
    方法:数据来自2017年10月1日至2023年10月1日期间在浙江省人民医院ICU接受NET治疗的误吸或胃喂养不耐受风险高的成年患者的病历。使用SPSS和R软件对收集的数据进行统计分析。
    结果:494例患者符合纳入和排除标准。首过成功率为81.4%(n=402)。发现患者初始NET放置的成功与角度SPC和距离CP有关,通过单变量分析确定(25.6±16.7°与41.9±18.0°,P<0.001;40.0±26.2mmvs.62.0±31.8mm,分别为P<0.001)。通过进行多元回归分析,我们发现幽门类型与NET置入成功率之间存在显著关联(OR29.559,95CI14.084-62.038,P<0.001).
    结论:角度SPC,距离CP,和幽门的类型与NET的成功初始放置独立相关。此外,幽门外侧型(OP型)患者的初始安置成功率较高.
    BACKGROUND: Patients in the intensive care unit (ICU) are highly susceptible to malnutrition, and while enteral nutrition via nasogastric tube is the preferred method, there is a risk of inadvertent reflux and aspiration. Therefore, clinicians have turned to nasointestinal tubes (NET) for enteral nutrition as an alternative option. But the precise localization of NET presents an ongoing challenge. We proposed an innovative approach to provide a valuable reference for clinicians involved in NET placement.
    METHODS: Data were obtained retrospectively from the medical records of adult patients with a high risk of aspiration or gastric feeding intolerance who had a NET placed in the ICU of Zhejiang Provincial People\'s Hospital between October 1, 2017, and October 1, 2023. The collected data were subjected to statistical analysis using SPSS and R software.
    RESULTS: There were 494 patients who met the inclusion and exclusion criteria. The first-pass success rate was 81.4% (n = 402). The success of a patient\'s initial NET placement was found to be associated with Angle SPC and Distance CP, as determined by univariate analysis (25.6 ± 16.7° vs. 41.9 ± 18.0°, P < 0.001; 40.0 ± 26.2 mm vs. 62.0 ± 31.8 mm, P < 0.001, respectively). By conducting a multivariate regression analysis, we identified a significant association between pyloric types and the success rate of placing NET (OR 29.559, 95%CI 14.084-62.038, P < 0.001).
    CONCLUSIONS: Angle SPC, Distance CP, and the type of pylorus are independently associated with successful initial placement of NET. Besides, patients with the outside type of pylorus (OP-type) exhibit a higher rate of initial placement success.
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  • 文章类型: Journal Article
    背景:准确确定鼻胃管的内部长度对于安全有效地完成盲插入至关重要,常规护理程序。广泛使用的鼻-耳垂-剑突距离缺乏证据和有效性。最近的一项随机对照试验提出了一种替代方案,校正后的鼻-耳垂-剑突距离公式。然而,其在现实临床实践中的有效性尚未被研究。
    目的:本研究评估了校正鼻-耳垂-剑突距离公式用于确定住院或重症监护病房的成年患者的内部鼻胃管长度的实际临床有效性。
    方法:进行单中心回顾性临床效果研究,利用常规收集的观测数据。
    在2020年10月至2022年11月之间,纳入了358名需要鼻饲管的综合医院成年患者。主要结果包括由高级实践护士通过X射线验证评估鼻胃管尖端定位(食管下括约肌下方>3cm)。次要结果,从100名参与者的随机亚组的患者记录中获得,通过回顾放射科医生报告尖端位置的清晰度和评估。
    结果:经过高级执业护士的评估,确定所有鼻饲管的正确位置。在100个管的分组中,X光检查方案,根据审查放射科医生的记录,显示了不同程度的管尖报告清晰度:4.0%缺乏报告,33.0%的报告不明确,63.0%的报告不明确。
    结论:校正后的鼻-耳垂-剑突距离公式显示有可能成为确定鼻胃管内部长度的现有方法的更安全的替代方法。
    结论:除了医疗保健提供者的教育和培训,建议放射科医师采用基于检查表的框架,明确报告鼻胃管尖端位置.
    BACKGROUND: Accurate determination of the internal length of nasogastric tubes is essential for the safe and effective completion of blind insertions, a routine nursing procedure. The widely used nose-earlobe-xiphoid distance lacks evidence and effectiveness. A recent randomized controlled trial proposed an alternative, the corrected nose-earlobe-xiphoid distance formula. However, its effectiveness in real-world clinical practice has not yet been studied.
    OBJECTIVE: This study assessed the real-world clinical effectiveness of the corrected nose-earlobe-xiphoid distance formula for determining the internal nasogastric tube length in adult patients admitted to hospitalization or intensive care units.
    METHODS: A single-center retrospective clinical effectiveness study was conducted, utilizing routinely collected observational data.
    UNASSIGNED: Between October 2020 and November 2022, 358 adult patients in a general hospital requiring a nasogastric feeding tube were included. The primary outcome involved assessing nasogastric tube tip positioning (>3 cm below the lower esophageal sphincter) by an advanced practice nurse through X-ray verification. Secondary outcomes, obtained from patient records for a random subgroup of 100 participants, were reporting clarity and evaluation of the tip position by reviewing radiologists.
    RESULTS: Following evaluation by an advanced practice nurse, all nasogastric feeding tubes were determined to be correctly positioned. Among the subgroup of 100 tubes, X-ray protocols, as documented by the reviewing radiologists, showed varying levels of reporting clarity for the tube tip: 4.0 % lacked reporting, 33.0 % had ambiguous reporting and 63.0 % had unambiguous reporting.
    CONCLUSIONS: The corrected nose-earlobe-xiphoid distance formula demonstrates potential to emerge as a safer alternative to existing methods for determining the internal length of nasogastric tubes.
    CONCLUSIONS: In addition to healthcare provider education and training, a checklist-based framework is recommended for radiologists to unambiguously report nasogastric tube tip positions.
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  • 文章类型: Journal Article
    背景:肠内营养是食管切除术后的首选营养方式。然而,肠内营养的首选模式(喂养空肠造口术(FJ)与鼻空肠(NJ)管)仍有争议。在这项随机对照试验(RCT)中,我们在安全性方面比较了FJ和NJ管喂养,可行性,功效,和生活质量(QOL)参数在印度患者中接受经食管食管切除术(THE)的食管癌。
    方法:这种单中心,双臂(FJ和NJ管),非劣效性RCT于2020年3月至2024年1月进行。48例患者接受了后纵隔胃拉拔术,并被随机分配到NJ和FJ组(每组24例)。术后并发症,导管功效,随访6周,比较两组患者的生活质量指标。
    结果:在此RCT中,我们发现导管相关并发症的发生率没有显着差异,术后并发症发生率,导管功效,NJ管和FJ管患者的视觉模拟疼痛评分,以下为食道癌。在NJ组中,自我报告的物理领域QOL得分明显更好,均在放电时(44.7±6.2vs39.8+5.6;p值,0.005)和6周随访(55.4±5.2vs48.6±4.5;p值,<0.001)。
    结论:根据我们RCT的发现,我们得出的结论是,两种肠内进入方法(新泽西州与FJ)显示导管相关并发症的发生率相当。使用NJ管是手术FJ的可行替代方案,有早期去除的好处,并节省了与每个腹部一根管子相关的痛苦。
    BACKGROUND: Enteral nutrition is the preferred mode of nutrition following esophagectomy. However, the preferred mode of enteral nutrition (feeding jejunostomy (FJ) vs. nasojejunal (NJ) tube) remains contentious. In this randomized controlled trial (RCT), we compared FJ with NJ tube feeding in terms of safety, feasibility, efficacy, and quality-of-life (QOL) parameters in Indian patients undergoing trans-hiatal esophagectomy (THE) for carcinoma esophagus.
    METHODS: This single-center, two-armed (FJ and NJ tube), non-inferiority RCT was conducted from March 2020 to January 2024. Forty-eight patients underwent THE with posterior-mediastinal-gastric pull-up and were randomized to NJ and FJ arms (24 in each group). The postoperative complications, catheter efficacy, and QOL parameters were compared between the two groups till the 6-week follow-up.
    RESULTS: In this RCT, we found no significant difference in the occurrence of catheter-related complications, postoperative complication rate, catheter efficacy, and visual analog pain scores between patients with NJ tube and FJ, following THE for esophageal cancer. There was a significantly better self-reported physical domain QOL score noted in the NJ group, both at the time of discharge (44.7 ± 6.2 vs 39.8 + 5.6; p value, 0.005) and at the 6-week follow-up (55.4 ± 5.2 vs 48.6 ± 4.5; p value, < 0.001).
    CONCLUSIONS: Based on the findings of our RCT, we conclude that both enteral access methods (NJ vs. FJ) exhibit comparable incidences of catheter-related complications. The use of NJ tube is a viable alternative to a surgical FJ, has the benefit of early removal, and saves the distress associated with a tube per abdomen.
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  • 文章类型: Journal Article
    背景:本研究比较了缺血性脑卒中患者实施肠盲置管综合护理方案后盲行和内镜引导下幽门后饲管置管的一次性成功率。
    方法:这项回顾性队列研究包括179例盲床旁放置患者和118例内窥镜引导放置患者。主要结果是经放射学证实的幽门后放置的一次性成功率。次要终点包括管尖端的位置,插入长度,放置时间,和费用。安全性终点是放置引起的并发症的发生率。
    结果:结果显示,置管方法对首次置管结果无显著影响(比值比[OR]=0.41;95%CI=0.137-1.207;P=0.105)。与内窥镜引导放置相比,盲人安置是成本的一半。我们还发现腹部手术史(OR=0.003;95%CI=0.000-0.059;P<0.001)和重症监护病房(ICU)天数(OR=0.94;95%CI=0.903-0.981;P=0.004)与一次性成功率呈负相关。
    结论:我们的研究表明,在缺血性卒中住院患者中,如果操作者能够接受良好的培训,与内窥镜引导下放置相比,盲目放置肠管具有同等的一次性成功率。然而,内窥镜引导下放置的费用是盲床旁方法的两倍。我们还发现,有腹部手术史和ICU住院时间较长的患者在首次放置时更有可能失败。需要进一步的研究来在更大的患者群体中复制我们的单中心观察结果。
    BACKGROUND: This study compared the one-time success rate of blind and endoscopy-guided postpyloric feeding tube placement after implementing a comprehensive nursing scheme of intestinal blind placement for patients with ischemic stroke.
    METHODS: This retrospective cohort study included 179 patients with blind bedside placement and 118 with endoscopy-guided placement. The primary outcome was the one-time success rate of radiologically confirmed postpyloric placement. The secondary endpoints included the position of the tube tip, length of insertion, time of placement, and expenses. The safety endpoints were the incidence of complications caused by placement.
    RESULTS: The results showed that the method of tube placement did not significantly affect the outcome of the first tube placement (odds ratio [OR] = 0.41; 95% CI = 0.137-1.207; P = 0.105). Compared with endoscopy-guided placement, blind placement was half the cost. We also found that a history of abdominal surgery (OR = 0.003; 95% CI  = 0.000-0.059; P < 0.001) and longer intensive care unit (ICU) days (OR = 0.94; 95% CI = 0.903-0.981; P = 0.004) were inversely associated with the one-time success rate.
    CONCLUSIONS: Our study suggested that blind intestinal feeding tube placement has an equivalent one-time success rate compared with endoscopy-guided placement in hospitalized patients with ischemic stroke if operators can be trained well. However, the expenses of endoscopy-guided placement were twice those of blind bedside methods. We also found that patients with abdominal surgery history and longer ICU stay were more likely to fail at the first placement. Further research is needed to replicate our single-center observations in a larger population of patients.
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  • 文章类型: Journal Article
    目的:评估pH测试的可靠性,以确认正在进行的鼻胃管(NGT)位置并记录相关并发症。
    背景:确认NGT职位至关重要,因为使用错误定位的管子会造成伤害。大量证据检查了NGT位置的初步确认,然而,有限的证据认为NGT位移是通过正在进行的NGT位置测试确定的。在NHS中,建议进行pH测试以确认正在进行的NGT位置;然而,这可能与X线检查过多以及肠内营养和/或药物的缺失有关.
    方法:使用STROBE检查表的前瞻性观察性研究。
    方法:从伦敦NHS信托基金的136名NGT患者的医疗记录中收集的数据包括pH值测试,与正在进行的pH测试有关的测试结果和并发症,未能确认管位于胃中,也就是说,X光片,以及肠内营养和药物的中断。科恩的Kappa确定了pH测试的可靠性。
    结果:为确认NGT位置而进行的1381项pH测试中,五个(0.3%)正确识别了NGT位移,1人(0.07%)在使用前未能识别位移。使用Cohen的Kappa进行的pH测试的可靠性最小(0.29)。正在进行的pH测试未能确认正确定位的NGT导致31(22.8%)患者接受X射线检查,24(17.6%)缺少>10%的规定肠内营养,25(18.4%)缺少关键药物。
    结论:使用pH测试进行NGT位置测试并不能阻止使用移位管,超过五分之一的患者需要X光检查来确认NGT的正确位置,有助于错过药物和肠内营养。
    结论:当通过pH测试确认正在进行的NGT位置时,应谨慎使用。未来的指南应平衡使用移位管的风险与营养和/或药物的潜在延迟。需要更多的研究来探索正在进行的NGT位置测试的替代方法。
    OBJECTIVE: To measure the reliability of pH testing to confirm ongoing nasogastric tube (NGT) position and to document associated complications.
    BACKGROUND: Confirming NGT position is essential, as use of an incorrectly positioned tube can cause harm. Substantial evidence examines initial confirmation of NGT position, yet limited evidence exists considers NGT displacement which is identified via ongoing NGT position tests. In the NHS, pH testing is recommended to confirm ongoing NGT position; however, there may be an association with excess X-rays and missed enteral nutrition and/or medications.
    METHODS: Prospective observational study using STROBE checklist.
    METHODS: Data collected from medical records of 136 patients with NGTs in a London NHS Trust included pH tests, test results and complications related to ongoing pH tests which failed to confirm the tube was positioned in the stomach, that is, X-rays, and disruptions to enteral nutrition and medication. Cohen\'s Kappa determined pH test reliability.
    RESULTS: Of 1381 pH tests conducted to confirm NGT position, five (0.3%) correctly identified an NGT displacement, and one (0.07%) failed to identify displacement before use. The reliability of ongoing pH tests using Cohen\'s Kappa was minimal (0.29). Ongoing pH tests that failed to confirm a correctly positioned NGT led to 31 (22.8%) patients having X-rays, 24 (17.6%) missing >10% of prescribed enteral nutrition and 25 (18.4%) missing a critical medication.
    CONCLUSIONS: Ongoing NGT position testing using pH tests did not prevent the use of a displaced tube, and more than one-fifth of patients required X-rays to confirm a correctly position NGT, contributing to missed medications and enteral nutrition.
    CONCLUSIONS: Caution should be used when confirming ongoing NGT position with a pH test. Future guidelines should balance the risk of using a displaced tube with potential delays to nutrition and/or medication. More research is needed to explore alternative methods of ongoing NGT position testing.
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  • 文章类型: Journal Article
    背景:唐氏综合征患者的喂养困难已得到广泛认可,许多患者需要放置胃造瘘管(G管)进行营养。尚未确定可靠的因素来预测唐氏综合征患者G管喂养的预期持续时间。这项描述性队列研究旨在确定影响G管饲料持续时间的因素。我们还调查了从G管放置到停药的体重指数(BMI)的变化。
    方法:回顾了1986年9月至2021年12月在三级护理中心由儿科胃肠病学家看到的唐氏综合征患者的病历。数据收集包括人口统计,人体测量学,合并症,和喂养路线。在停止G管喂养的患者和未停止G管喂养的患者之间进行了比较。
    结果:纳入了220例患者(45%为女性)。放置G管时的中位年龄为5个月(四分位距[IQR]:0.2-1.3岁)。有113名(51%)患者停止了G管喂养,在中位持续时间为31.6个月后(IQR:15.6-55.7个月)。气管造口术是唯一与G管喂养持续时间更长相关的协变(158个月对53个月;P=0.002)。放置G管时的年龄或任何合并症均与停止G管时的BMI状态无关。
    结论:在我们的唐氏综合征患者队列中,放置G管的年龄不影响G管喂养的持续时间。大多数放置了G管的患者可能需要肠内喂养至少1年。那些进行气管造口术的人需要更长的时间。
    BACKGROUND: Feeding difficulty is widely recognized in patients with Down syndrome, and many patients require gastrostomy tube (G-tube) placement for nutrition. No reliable factors have been identified to predict the expected duration of G-tube feeds in patients with Down syndrome. This descriptive cohort study aimed to determine the factors affecting the duration of G-tube feeds. We also investigated change in body mass index (BMI) from G-tube placement to discontinuation.
    METHODS: Medical records of patients with Down syndrome seen by a pediatric gastroenterologist at a tertiary care center between September 1986 and December 2021 were reviewed. Data collection included demographics, anthropometrics, comorbidities, and feeding route. Comparison was performed between patients who discontinued G-tube feeds and those who did not.
    RESULTS: Two hundred twenty patients (45% female) were included. The median age at G-tube placement was 5 months (interquartile range [IQR]: 0.2-1.3 years). There were 113 (51%) patients who discontinued G-tube feeds, after a median duration of 31.6 months (IQR: 15.6-55.7 months). Tracheostomy was the only covariant associated with a longer duration of G-tube feeds (158 months vs 53 months; P = 0.002). Neither age at G-tube placement nor any comorbidities were associated with BMI status at discontinuation of G-tube.
    CONCLUSIONS: In our cohort of patients with Down syndrome, age at placement of G-tube did not impact the duration of G-tube feeds. Most patients who had a G-tube placed were likely to require enteral feeds for at least 1 year. Those who had a tracheostomy needed their G-tube for a longer time.
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  • 文章类型: Comparative Study
    目的:确定经鼻肠管意外置入呼吸道的发生率。比较检查正确放置管的方法。比较鼻食管和鼻胃管的并发症发生率。
    方法:需要经鼻肠管喂养的动物被前瞻性地随机分配,以放置鼻食管或鼻胃管。将评估导管位置的各种技术与胸部影像学检查结果进行了比较。记录放置和使用期间的并发症。
    结果:研究了97只动物(82只狗和15只猫)。在3例(3.1%)中,管子被错放到呼吸道中。没有检查放置的技术与X线照相术完全一致,但在86.2%的病例中,放置期间胸腔入口处的负压与食管中的导管一致。而二氧化碳描记术可以考虑确认气管放置。置管期间并发症的总发生率为25.8%,据报道,大多数是轻微的临床并发症。新发返流/呕吐率无显著差异,或并发症,而在鼻食管和鼻胃组之间的管在原位。
    结论:经鼻肠管的错位并不常见,但没有证明用于检查经鼻肠管正确放置的X线照相术的一致替代测试。选择鼻食管或鼻胃管的位置应根据临床医生的喜好进行指导。应警告客户在放置过程中以及在鼻肠管原位时可能出现的并发症。
    OBJECTIVE: To determine the rate of accidental placement of nasoenteric tubes into the respiratory tract. To compare the methods of checking correct tube placement. To compare the complication rates between nasoesophageal and nasogastric tubes.
    METHODS: Animals requiring nasoenteric feeding tubes were prospectively randomised to have either nasoesophageal or nasogastric tube placement. Various techniques for assessing tube position were compared with thoracic radiographic findings. Complications during placement and use were recorded.
    RESULTS: Ninety-seven animals (82 dogs and 15 cats) were studied. The tube was misplaced into the respiratory tract in three (3.1%) cases. No technique for checking placement was completely concordant with radiography but the presence of negative pressure at the thoracic inlet during placement was consistent with the presence of the tube in the oesophagus in 86.2% cases, while capnography can be considered to confirm tracheal placement. The overall rate of complications during tube placement was 25.8%, with mostly minor clinical complications reported. There was no significant difference in the new-onset regurgitation/vomiting rate, or complications while the tube was in situ between the nasoesophageal and nasogastric groups.
    CONCLUSIONS: Misplacement of nasoenteric tubes is uncommon but a consistent alternative test to radiography for checking correct nasoenteric tube placement was not demonstrated. The choice of placement of either a nasoesophageal or nasogastric tube should be guided by clinician preference, and clients should be warned about possible complications during placement and while the nasoenteric tube is in situ.
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  • 文章类型: Journal Article
    目的:本研究旨在评估使用安抚奶嘴的疗效,有和没有25%的葡萄糖,减少新生儿口胃管插入过程中的疼痛。
    方法:在2019年4月至12月在公立医院进行的一项涉及60名新生儿的随机对照试验中,参与者分为三组:安抚奶嘴(n=20),含25%葡萄糖的安抚奶嘴(n=20),和对照(n=20)。安抚奶嘴,有和没有葡萄糖,用于实验组,而对照组执行常规程序。新生儿疼痛量表,哭泣的持续时间,心率(HR),和氧饱和度(SpO2)进行评估。
    结果:结果表明,对照组的疼痛程度明显升高,升高的HR,SpO2降低,长时间哭泣。相反,含25%葡萄糖的安抚奶嘴组哭闹时间显著缩短。
    结论:安抚奶嘴,有和没有25%的葡萄糖,有效地减轻疼痛,改善口胃管插入过程中的生理和行为参数。
    背景:NCT05462964临床试验注册:该随机对照实验试验的方案已在ClinicalTrials.gov上注册。临床试验注册号为https://clinicaltrials.gov;NCT05462964。
    OBJECTIVE: This study aimed to assess the efficacy of pacifier use, with and without 25% dextrose, in reducing pain during orogastric tube insertion in newborns.
    METHODS: In a randomized controlled trial involving 60 newborns at a public hospital from April to December 2019, participants were divided into three groups: pacifier (n = 20), pacifier with 25% dextrose (n = 20), and control (n = 20). A pacifier, with and without dextrose, was used for the experimental groups, while the control group performed a routine procedure. Neonatal infant pain scale, crying duration, heart rate (HR), and oxygen saturation (SpO2) were evaluated.
    RESULTS: Results indicated that the control group experienced significantly higher pain levels, elevated HRs, decreased SpO2, and prolonged crying. Conversely, the pacifier with 25% dextrose group showed a notable reduction in crying duration.
    CONCLUSIONS: A pacifier, with and without 25% dextrose, effectively reduces pain and improves physiological and behavioral parameters during orogastric tube insertion.
    BACKGROUND: NCT05462964 CLINICAL TRIAL REGISTRATION: The protocol for this randomized controlled experimental trial is registered on ClinicalTrials.gov. The clinical trial registration number is https://clinicaltrials.gov ; NCT05462964.
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  • 文章类型: Clinical Trial
    确认在护理点放置鼻胃管(NGT)的负担得起且可靠的方法是未满足的需求。使用一种新颖的算法和很少的传感器,我们开发了一种低成本的磁铁跟踪设备,并显示了其在临床前定位NGT的潜力。这里,我们开始了首次人体试验.招募了来自城市医院普通病房的6名男性和4名女性NGT患者。我们使用该设备定位NGT,并将其与胸部X射线(CXR)进行比较。在5名患者中,传感器放在胸骨角上,跟踪设备再现了NGT的轨迹。NGT的跟踪位置偏离CXR0.55至1.63厘米,并且实现了从胸骨角向下跟踪17到22厘米的范围。将传感器放在下胸骨上,然而,导致设备的本地化与CXR上的本地化之间存在明显的不一致。胸骨角和胸骨之间的短距离,在跟踪可行的患者中观察到较低的体重。追踪速度快,耐受性好。无不良事件发生。当适当放置时,该装置可行地将NGT定位在50%的患者中。预计会有进一步的改进。ClinicalTrials.gov标识符:NCT05204901。
    An affordable and reliable way of confirming the placement of nasogastric tube (NGT) at point-of-care is an unmet need. Using a novel algorithm and few sensors, we developed a low-cost magnet tracking device and showed its potential to localize the NGT preclinically. Here, we embark on a first-in-human trial. Six male and 4 female patients with NGT from the general ward of an urban hospital were recruited. We used the device to localize the NGT and compared that against chest X-ray (CXR). In 5 patients, with the sensors placed on the sternal angle, the trajectory of the NGT was reproduced by the tracking device. The tracked location of the NGT deviated from CXR by 0.55 to 1.63 cm, and a downward tracking range of 17 to 22 cm from the sternal angle was achieved. Placing the sensors on the xiphisternum, however, resulted in overt discordance between the device\'s localization and that on CXR. Short distance between the sternal angle and the xiphisternum, and lower body weight were observed in patients in whom tracking was feasible. Tracking was quick and well tolerated. No adverse event occurred. This device feasibly localized the NGT in 50% of patients when appropriately placed. Further refinement is anticipated.ClinicalTrials.gov identifier: NCT05204901.
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