Do Balloon Catheters have a Different Radial Force Along Their Longitudinal Axis?

PURPOSE: This experimental study was designed to compare radial forces between the central portion and both ends of balloon catheters when dilating stenosis. MATERIALS AND METHODS: Three balloon catheters of 6 and 8 mm in diameter and of variable length were tested: Mustang, Conquest, and Genoss PTA. Cylindrical modules to position balloon catheters and install the measuring tip during radial force measurements were made using a 3D printer. The measuring tip created 20% stenosis at the inner lumen. Both ends and center of the balloon catheter were located at the measuring tip. The radial force was measured after inflating the balloon catheter to the rated burst pressure. RESULTS: For the different diameters and lengths of balloon catheters and cylinder sizes, the median inccenter, the radial rease in radial force at the distal end compared to the center was 16.5% (range: 9.8-35.2%) for Mustang, 12.4% (range: 10.3-25.5%) for Genoss, and 7.4% (range: -0.3-13.1%) for Conquest balloon catheters. Similarly, compared to that at the force at the proximal end was 10.8% greater (range: -2.9-18.3%) for Mustang, 9.9% greater (range: 3.9-22.3%) for Genoss, and 7.3% greater (range: -1.3-12.4%) for Conquest catheters. CONCLUSION: The radial force is greater at both ends of the balloon than at the central portion, especially at the distal end. Dilation using the distal end of the balloon catheter is a practical method that can be applied in clinical practice without additional devices when encountering resistant stenosis, especially with semi-compliant balloons.

Coil embolization of a celiac artery pseudoaneurysm under balloon-assisted flow control: A case report.

Coil migration can occur when coil embolization is used for treating pseudoaneurysms associated with large arteries. The double microcatheter technique is useful for preventing coil migration; the balloon catheter can reduce blood flow and active bleeding upon balloon inflation, and can also compress the bleeding point and arrest bleeding temporarily. We report a case describing the management of a pseudoaneurysm with coil embolization using double microcatheters and a balloon catheter to control blood flow and prevent coil migration. A 73-year-old male patient presented with a pseudoaneurysm of the celiac artery arising from the splenic artery stump following surgery. Coil embolization of the pseudoaneurysm using a double microcatheter embolization technique with a balloon catheter was considered. A balloon catheter was inserted into the celiac artery and active bleeding was temporarily arrested with the inflated balloon. First, a microcatheter was inserted into the balloon catheter, and another microcatheter was placed in the celiac artery. An electrical detachable coil was inserted into the proximal common hepatic artery just distal to the pseudoaneurysm. The second electrically detachable coil was inserted while the first coil remained attached. After detachment of the second coil, additional electrically detachable coils were inserted for similar embolization. The balloon was gradually deflated. Finally, the first coil was detached and we confirmed absence of the bleeding. Our case report demonstrated that a balloon catheter can control the flow vessels, and the double microcatheter embolization technique with a balloon catheter is useful for coil embolization in high-flow or large vessels.

Successful coil embolization of post-hepatectomy arterioportal fistula that reduced ascites and improved liver function.

A 71-year-old man had previously undergone S7 + S8 dorsal segmentectomy and S5 partial hepatectomy for hepatocellular carcinomas. Six months later, he experienced abdominal distention. Abdominal computed tomography (CT) showed massive ascites and a significant hepatic arterioportal shunt. The ascites was thought to be caused by portal hypertension due to a high-flow hepatic arterioportal fistula (HAPF). The fistula, located between the right hepatic artery A7 and the right portal vein, was embolized with microcoils under flow control using a balloon catheter. After embolization, the shunt blood flow disappeared and the hepatopetal venous flow was restored. His body weight and abdominal circumference decreased immediately, and his liver function on blood tests improved after the procedure. CT performed 11 days after embolization showed decreased ascites. A HAPF after hepatectomy is extremely rare. Balloon-assisted embolization using microcoils is a useful endovascular procedure for treating a high-flow HAPF.

Methods for the induction of labor: efficacy and safety.

This review assessed the efficacy and safety of pharmacologic agents (prostaglandins, oxytocin, mifepristone, hyaluronidase, and nitric oxide donors) and mechanical methods (single- and double-balloon catheters, laminaria, membrane stripping, and amniotomy) and those generally considered under the rubric of complementary medicine (castor oil, nipple stimulation, sexual intercourse, herbal medicine, and acupuncture). A substantial body of published reports, including 2 large network meta-analyses, support the safety and efficacy of misoprostol (PGE1) when used for cervical ripening and labor induction. Misoprostol administered vaginally at doses of 50 µg has the highest probability of achieving vaginal delivery within 24 hours. Regardless of dosing, route, and schedule of administration, when used for cervical ripening and labor induction, prostaglandin E2 seems to have similar efficacy in decreasing cesarean delivery rates. Globally, although oxytocin represents the most widely used pharmacologic agent for labor induction, its effectiveness is highly dependent on parity and cervical status. Oxytocin is more effective than expectant management in inducing labor, and the efficacy of oxytocin is enhanced when combined with amniotomy. However, prostaglandins administered vaginally or intracervically are more effective in inducing labor than oxytocin. A single 200-mg oral tablet of mifepristone seems to represent the lowest effective dose for cervical ripening. The bulk of the literature assessing relaxin suggests this agent has limited benefit when used for this indication. Although intracervical injection of hyaluronidase may cause cervical ripening, the need for intracervical administration has limited the use of this agent. Concerning the vaginal administration of nitric oxide donors, including isosorbide mononitrate, isosorbide, nitroglycerin, and sodium nitroprusside, the higher incidence of side effects with these agents has limited their use. A synthetic hygroscopic cervical dilator has been found to be effective for preinduction cervical ripening. Although a pharmacologic agent may be administered after the use of the synthetic hygroscopic dilator, in an attempt to reduce the interval to vaginal delivery, concomitant use of mechanical and pharmacologic methods is being explored. Combining the use of a single-balloon catheter with dinoprostone, misoprostol, or oxytocin enhances the efficacy of these pharmacologic agents in cervical ripening and labor induction. The efficacy of single- and double-balloon catheters in cervical ripening and labor induction seems similar. To date, the combination of misoprostol with an intracervical catheter seems to be the best approach when balancing delivery times with safety. Although complementary methods are occasionally used by patients, given the lack of data documenting their efficacy and safety, these methods are rarely used in hospital settings.

Randomized control trial comparing hygroscopic cervical dilators to cervical ripening balloon for outpatient cervical ripening.

BACKGROUND: Outpatient term preinduction cervical ripening with mechanical agents has been associated with reduced length of stay, decreased cesarean delivery rates, low maternal and neonatal complications, and increased incidence of vaginal delivery within 24 hours. OBJECTIVE: This study aimed to demonstrate equivalent efficacy between synthetic hygroscopic dilators and the single-balloon catheter for outpatient cervical ripening. STUDY DESIGN: This randomized control equivalence trial compared synthetic hygroscopic dilators with the 30-mL silicone single-balloon catheter in primiparous and multiparous patients undergoing labor induction. The primary outcome was time from admission to delivery, with a prespecified 3-hour margin of equivalence. The secondary objectives were patient outcomes and perspectives. RESULTS: Between March 1, 2019, and May 31, 2021, 1605 patients met the screening criteria, and 174 patients completed the study. The mean admission-to-delivery time was equivalent at 18.01 hours for the dilator group vs 17.55 hours for the balloon group (P=.04). The cesarean delivery rate of primiparous patients was similar at 28.1% with dilators vs 29.7% with the balloon. The groups had similar median cervical dilation and pain scores on insertion and admission. Overall patient satisfaction was high, 92.8% with dilators vs 96.2% with the balloon. The balloon group had significantly higher rates of early admission and device expulsion. CONCLUSION: Although the enrollment goal was not met, our study suggests that synthetic hygroscopic dilators and the single-balloon catheter for outpatient cervical ripening are both efficacious with similar time from admission to delivery, pain scores, and patient satisfaction with the procedure.

Balloon Dilatation for Bronchoscope Delivery in a Swine Model: A Novel Technique for Ultra-Peripheral Lung Field Access and Accurate Biopsy.

INTRODUCTION: In transbronchial biopsy of peripheral pulmonary lesions, the bronchoscope can reach only a limited depth due to the progressive narrowing of bronchi, which may reduce the diagnostic rate. This study examined the balloon dilatation for bronchoscope delivery (BDBD) technique, employing a novel balloon device to enhance bronchoscopy into the peripheral lung areas. METHODS: Anaesthetised swine served as our primary model. Using computed tomography (CT) scans, we positioned virtual targets characterised by a positive bronchus sign and a diameter of 20 mm beneath the pleura. The bronchoscope was navigated along the pathways determined from the CT images. We performed balloon dilatation when bronchial narrowing obstructed progress to assess whether balloon dilatation would enable the bronchoscope to enter further into the periphery. RESULTS: We established 21 virtual targets on the CT scans. An average of 12.1 branches were identified along the pathways on the CT scans; however, bronchoscopy without BDBD only allowed access to an average of 6.7 branches. Based on 72 balloon dilatations with 3.0-mm or 4.0-mm ultra-thin bronchoscopes, there was an average increased access of 3.43 and 5.14 branches per route, respectively, with no significant BDBD complications. The bronchoscope was able to reach the planned location along all pathways, and the mean final bronchoscopic endpoints were at an average distance of 14.7 mm from the pleura. Post-procedure CT confirmed biopsy accuracy. CONCLUSION: The BDBD technique can enhance access of a flexible bronchoscope into the peripheral lung fields, which could potentially allow more accurate transbronchial interventions for peripheral targets.

Self-Traction During Mechanical Cervical Dilatation, Acceptability, Feasibility and Satisfaction of its Application: A Pilot Study.

This study aims to measure acceptability, feasibility, and satisfaction with self-traction during mechanical cervical dilatation to induce labour and to explore its effects on pain and the process of labour and delivery. 60 parturients were randomly assigned to self-traction or regular traction. Participants completed questionnaires about sociodemographic characteristics, acceptability, and satisfaction. Self-traction participants reported significantly higher acceptability (P = 0.026), and adequacy (P = 0.018). They also reported satisfaction with the procedure. A group comparison regarding feasibility, pain, and the process of labour and delivery showed no significant difference. Self-traction is an acceptable and feasible intervention for full-term parturients.

Outpatient cervical ripening with balloon catheters: A Bayesian network meta-analysis of randomized controlled trials.

BACKGROUND: One in four labors are induced. The process of cervical ripening can be lengthy and pre-labor hospitalization is required. Outpatient cervical ripening can be an attractive alternative. OBJECTIVES: To evaluate the efficacy and safety of outpatient cervical ripening with a balloon catheter compared with inpatient balloon catheter or prostaglandin E2 (PGE2 ). SEARCH STRATEGY: The PubMed, MEDLINE, Embase, ClinicalTrials.gov, and Cochrane Library databases were searched from their inception to October 15, 2022. SELECTION CRITERIA: Randomized controlled trials comparing the outpatient balloon catheter with inpatient balloon catheter or inpatient PGE2 for term cervical ripening. DATA COLLECTION AND ANALYSIS: Bayesian network meta-analysis was performed. The primary outcome was the cesarean delivery rate. The secondary outcomes included instrumental delivery, the time from intervention-to-birth, oxytocin augmentation, total hospital duration, and maternal/neonatal adverse events. MAIN RESULTS: Twenty-nine randomized controlled trials with a total of 6004 participants were identified. No difference in the cesarean delivery rate was revealed among the three interventions. Compared with inpatient balloon catheter, outpatient balloon catheter had shorter total hospital duration (mean difference -8.58, 95% confidence interval -17.02 to -1.10). No differences were revealed in the time from intervention-to-birth, instrumental delivery, postpartum hemorrhage, 5-min Apgar score less than 7, umbilical cord arterial pH less than 7.1, and neonatal intensive care unit admission among the three interventions. CONCLUSIONS: Outpatient balloon catheter in low-risk term pregnancies is an available option that could be considered for cervical ripening. The safety and effectiveness are comparable to inpatient cervical ripening methods.

Resuscitative endovascular balloon occlusion of the aorta (REBOA) as adjunct treatment in life threatening postpartum hemorrhage: Fourteen years' experience from a single Norwegian center.

INTRODUCTION: Postpartum hemorrhage (PPH) remains a global health problem. The introduction of resuscitative endovascular balloon occlusion of the aorta (REBOA) in 2008 sought to enhance the management of hemorrhagic shock during PPH. In this study, we present a single Norwegian center's experience with REBOA as a supportive treatment in combating life threatening PPH. MATERIAL AND METHODS: This is a historical cohort study from St Olav's University Hospital, with data from period 2008-2021. It includes all patients who underwent REBOA as an adjunct treatment due to life threatening PPH, analyzing the outcomes and trends over a 14-year period. RESULTS: A total of 37 patients received REBOA as an adjunct treatment. All procedures were technically successful, achieving hemodynamic stability with an immediate average increase in systolic blood pressure of 36 ± 22 mmHg upon initial balloon inflation. Additionally, a downward trend was noted in the frequency of hysterectomies and the volume of blood transfusions required over time. No thromboembolic complications were observed. CONCLUSIONS: Our 14 years of experience at St Olav's Hospital suggests that REBOA serves as a safe and effective adjunct interventional technique for managing life-threatening PPH. Furthermore, the findings indicate that incorporating a multidisciplinary approach to enable rapid aortic occlusion can potentially reduce the necessity for blood transfusions and hysterectomies.

Efficacy and safety of double balloon catheter and dinoprostone for labor induction in multipara at term.

PURPOSE: The aim of this study was to comparatively assess the efficacy and safety of double balloon catheter (DBC) and dinoprostone as labor-inducing agents just for multipara at term. METHODS: A retrospective cohort study was conducted among multipara at term with a Bishop score < 6 who needed planned labor induction from January 1, 2020, to December 30, 2020 in Maternal and Child Health Hospital of Hubei province, Tongji Medical College, Huazhong University of Science and Technology. They were divided into DBC group and dinoprostone group, respectively. Baseline maternal data, maternal and neonatal outcomes were recorded for statistical analysis. Total vaginal delivery rate, rate of vaginal delivery within 24 h, rate of uterine hyperstimulation combined with abnormal fetal heart rate(FHR) were regarded as the primary outcome variables. The difference between groups was considered statistically significant when p value < 0.05. RESULTS: A total of 202 multiparas was included for analysis (95 women in DBC group vs 107 women in dinoprostone group). There were no significant differences in total vaginal delivery rate and rate of vaginal delivery within 24 h between groups. Uterine hyperstimulation combined with abnormal FHR occurred exclusively in dinoprostone group. CONCLUSION: DBC and dinoprostone seem to be equally effective, while, DBC seems to be safer than dinoprostone.

[Comparison of vaginal prostaglandins with oral misoprostol as a second line of cervical ripening after using a cervical balloon catheter]. / Comparaison des prostaglandines vaginales au misoprostol oral en 2e ligne de maturation cervicale après recours à un ballonnet de dilatation cervicale.

OBJECTIVE: To compare vaginal prostaglandins with oral misoprostol as a second line of cervical ripening after using a cervical balloon catheter. MATERIAL AND METHODS: This is a retrospective monocentric study (Lille, France), according to a "before"/"after" design. The inclusion criteria were a singleton pregnancy, with a fetus in cephalic presentation, a term >37 WA, with a cervix having a Bishop score lower than 6 after a first line of maturation by cervical balloon catheter. Two groups were formed: "before" corresponding to the continuation of maturation by vaginal prostaglandins, from March 2019 to November 2019, and "after": corresponding to the continuation of maturation by oral misoprostol, from June 2020 to December 2020. The primary outcome was vaginal delivery rate. RESULTS: One hundred women were included in each group. The rate of vaginal delivery was similar between the 2 groups (76% vs 81%, p=0.39), as were the times between the start of induction and the birth and between the start of induction and the transition to birth room. There was no difference in the indication for caesarean section, with in particular an identical rate of caesarean sections for induction failure (p=0.52). Subgroup analysis in obese women showed a significantly higher rate of vaginal delivery in the "after" group (OR=4.17;95% CI [1.02;17.07]). CONCLUSION: The vaginal delivery rate is similar when using vaginal prostaglandins or oral misoprostol as second line cervical ripening after use of a cervical balloon catheter.

The infection, cervical and perineal lacerations in relation to postpartum hemorrhage following vaginal delivery induced by Cook balloon catheter.

OBJECTIVE: To identify whether infection, cervical laceration and perineal laceration are associated with postpartum hemorrhage in the setting of vaginal delivery induced by Cook balloon catheter. MATERIALS AND METHODS: The retrospective study included 362 women who gave birth vaginally at or beyond 37 weeks of gestation with a diagnosis of postpartum hemorrhage between February 2021 to May 2022, of which including 216 women with induction of labor (Cook balloon catheter followed by oxytocin or oxytocin) and 146 women with spontaneous delivery. Risk factors for postpartum hemorrhage were collected and compared. RESULTS: 362 women were divided into three groups, group 1 with spontaneous delivery, group 2 with oxytocin, group 3 with Cook balloon catheter followed by oxytocin. There was no significant difference in incidence of infection within three groups (P > 0.05). The rate of cervical laceration and perineal laceration was significantly higher in group 3 compared with groups 2 and 1 (P < 0.05); Multivariate logistic regression analysis found that compared with group 1, either group 3 or group 2 was associated with increased risks of cervical laceration and perineal laceration (P < 0.05), and compared with group 2, group 3 was not associated with increased risks of cervical laceration and perineal laceration (P > 0.05). CONCLUSION: Infection, cervical laceration and perineal laceration are identified not to be independent risk factors for postpartum hemorrhage for women undergoing labor with Cook balloon catheter; Cervical laceration and perineal laceration increase the risk of postpartum hemorrhage in women with labor induction.

Comparison of Outcomes between a Basket Catheter and a Balloon Catheter for Endoscopic Common Bile Duct Stone Removal.

INTRODUCTION: Evidence for the outcomes of endoscopic retrograde cholangiopancreatography (ERCP) between a basket catheter and a balloon catheter for endoscopic common bile duct stone (CBDS) removal is lacking. This study aimed to compare ERCP outcomes using a basket catheter and a balloon catheter for endoscopic CBDS removal. METHODS: This multicenter retrospective study included 904 consecutive patients with native papilla who underwent endoscopic stone removal for CBDS ≤10 mm using a basket catheter and/or a balloon catheter at three institutions in Japan. ERCP outcomes between the basket and balloon groups were compared using inverse probability of treatment weighting (IPTW) method. RESULTS: ERCP-related adverse events occurred in 6.5% (29/449) and 7.7% (35/455) of patients in the basket and balloon groups, respectively (IPTW-adjusted p = 0.52). The incidences of post-ERCP pancreatitis, cholangitis, and perforation were similar in the basket and balloon groups (3.8% vs. 2.9%, 1.3% vs. 0.9%, and 0.7% vs. 0.7%, respectively). However, bleeding incidences were significantly higher in the balloon group than in the basket group (3.3% vs. 0.7%, IPTW-adjusted p = 0.012). Successful complete stone removal at one ERCP session using a single catheter was achieved in 17.8% (80/449) in the basket group and in 81.3% (370/455) in the balloon group (IPTW-adjusted p < 0.001). DISCUSSION: A balloon catheter is more likely to complete stone extraction for CBDS ≤10 mm with a single catheter at one endoscopic stone removal session. However, the risk for post-ERCP bleeding is higher in the balloon group than in the basket group.

Esophageal balloon catheter system identification to improve respiratory effort time features and amplitude determination.

Objective. Understanding a patient's respiratory effort and mechanics is essential for the provision of individualized care during mechanical ventilation. However, measurement of transpulmonary pressure (the difference between airway and pleural pressures) is not easily performed in practice. While airway pressures are available on most mechanical ventilators, pleural pressures are measured indirectly by an esophageal balloon catheter. In many cases, esophageal pressure readings take other phenomena into account and are not a reliable measure of pleural pressure.Approach.A system identification approach was applied to provide accurate pleural measures from esophageal pressure readings. First, we used a closed pressurized chamber to stimulate an esophageal balloon and model its dynamics. Second, we created a simplified version of an artificial lung and tried the model with different ventilation configurations. For validation, data from 11 patients (five male and six female) were used to estimate respiratory effort profile and patient mechanics.Main results.After correcting the dynamic response of the balloon catheter, the estimates of resistance and compliance and the corresponding respiratory effort waveform were improved when compared with the adjusted quantities in the test bench. The performance of the estimated model was evaluated using the respiratory pause/occlusion maneuver, demonstrating improved agreement between the airway and esophageal pressure waveforms when using the normalized mean squared error metric. Using the corrected muscle pressure waveform, we detected start and peak times 130 ± 50 ms earlier and a peak amplitude 2.04 ± 1.46 cmH2O higher than the corresponding estimates from esophageal catheter readings.Significance.Compensating the acquired measurements with system identification techniques makes the readings more accurate, possibly better portraying the patient's situation for individualization of ventilation therapy.

The use of adjunctive mechanical dilation at the time of induction termination and adverse health outcomes: a systematic review.

OBJECTIVE: This study aimed to assess if the use of mechanical dilation at the time of induction termination is associated with changes in the time from initiation of labor to expulsion of the fetus (induction-to-expulsion interval) and with the frequency of health complications when compared with medication management alone. DATA SOURCES: PubMed, CINAHAL, Scopus, and the Cochrane Central Register of Controlled Trials were queried from January 2000 to May 2023. STUDY ELIGIBILITY CRITERIA: We included randomized controlled trials of individuals who were assigned to undergo mechanical dilation (ie, laminaria, Dilapan-S, and intracervical Foley balloon catheter) in combination with the use of medication and compared it with the outcomes of medication use (eg, prostaglandins, antiprogestins, oxytocin) alone. METHODS: The primary outcome was the induction-to-expulsion interval. The secondary outcomes were the incidence of clinical chorioamnionitis, sepsis, hemorrhage, the need for blood transfusion and uterotonics, cervical laceration, the need for adjunctive procedures (eg, dilation and curettage), failed induction termination, uterine rupture, intensive care unit admission, or death. Assessment of bias was performed using the Cochrane Risk of Bias tool. A subgroup analysis was performed among studies deemed to be at low risk of bias. RESULTS: Of 864 abstracts identified, 11 met the inclusion criteria. Five studies demonstrated a shorter induction-to-expulsion interval among those randomized to mechanical dilation, whereas 6 studies demonstrated a similar or longer induction-to-expulsion interval. There were no significant differences reported in the frequency of any adverse outcomes between the trial arms. In addition, most studies (8/11) exhibited moderate to high levels of bias. In an analysis of the 3 studies deemed to have a low risk of bias, 1 (n=60) demonstrated a longer induction-to-expulsion interval with adjunctive laminaria, 1 (n=60) demonstrated a shorter induction-to-expulsion interval with adjunctive intracervical Foley balloon catheter use, and 1 demonstrated no difference in the induction-to-expulsion interval with adjunctive Dilapan-S use (n=180). CONCLUSION: Only a small number of studies, most of which were of low quality, assessed mechanical dilation for induction termination. The results of these studies were inconsistent in terms of the induction-to-expulsion interval of adjunctive mechanical methods in comparison with medication management alone. Studies did not reveal significant differences between the groups in adverse outcomes. Further research should investigate the use of mechanical dilation at the time of induction termination using high-quality methods.

Synthetic Osmotic Dilators for Pre-Induction Cervical Ripening - an Evidence-Based Review.

Mechanical methods have gained growing interest for pre-induction cervical ripening in women with an unripe cervix, since they have a better safety profile compared to prostaglandins. Balloon catheters have been the gold standard method for decades, while there was a lack of data on synthetic osmotic cervical dilators. Not until 2015, when Dilapan-S was approved by the Food and Drug Administration (FDA) for induction of labor, numerous studies have been published on the use of Dilapan-S in this field. The rate of vaginal deliveries associated with the use of Dilapan-S ranges from 61.6 to 81.7%, and no serious complications needing further interventions have been reported to this date. Dilapan-S was shown to be as effective as the Foley balloon catheter as well as the 10 mg PGE 2 vaginal insert and orally applied misoprostol (25 µg every 2 hours) in achieving vaginal delivery, but patient's satisfaction during the cervical ripening process was significantly higher compared to the other methods and the rate of uterine hyperstimulation was significantly lower compared to prostaglandins (PGs). Minor complications (e.g. vaginal bleeding) associated with the use of Dilapan-S were < 2%, and maternal infectious morbidity was not higher compared to Foley balloon and vaginal PGE 2 or misoprostol. Due to these beneficial properties Dilapan-S might be an ideal option for outpatient cervical ripening, as shown in a recent randomized clinical trial comparing inpatient to outpatient cervical ripening. Furthermore, according to the manufacturers' product information, Dilapan-S is the only cervical ripening method that is not contraindicated for induction of labor in women with a previous cesarean section. Upcoming guidelines should consider synthetic osmotic cervical dilators as an effective and safe method for cervical ripening/induction of labor acknowledging that more evidence-based data are mandatory, particularly in patients with a previous cesarean section.

Induction of Labour with a Double Balloon Catheter - Comparison of Effectiveness of Six Versus Twelve Hours Insertion Time: a Prospective Case Control Study.

Introduction: Induction of labour is a common obstetric procedure to initiate or augment contractions when labour is delayed or uncertain. The double balloon catheter is a safe and effective mechanical method for cervical ripening during induction of labour. This study evaluates the effectiveness of reducing double balloon catheter insertion time from 12 to 6 hours. Methods: 248 women undergoing induction with a double balloon catheter at term were divided into two groups: catheter placed for 12 hours at 8 pm in the first half of 2021 (P12) and catheter placed for 6 hours at 7 am in the second half of 2021 (P6). T-tests, chi-squared tests, and Wilcoxon signed rank test were used for statistical analysis. Primary and secondary endpoints included induction to delivery interval, prostaglandin to delivery interval, mode of delivery, and maternal and neonatal outcomes. Results: The P6 group had a significantly reduced induction to delivery interval of 558 min (P6: 1348 min, P12: 1906 min, p < 0.01, 95% CI: 376-710) within demographically comparable groups. Multiparous women also showed a significant reduction in prostaglandin to delivery interval of 260 min (P6: 590 min, P12: 850 min, p = 0.038, 95% CI: 9-299). There were no significant differences in mode of delivery, maternal blood loss, or neonatal outcome. Conclusion: Reducing double balloon catheter placement time from 12 to 6 hours resulted in almost 9 hours less induction to delivery interval without adverse effects on maternal and neonatal outcome.

Percutaneous Balloon Catheter Occlusion to Treat Extravasation from an Inferior Vena Cava Laceration Associated With a Pelvic Fracture Following Blunt Abdominal Trauma: A Case Report.

Blunt abdominal injury with pelvic fracture is common in polytrauma cases and is a major challenge for emergency physicians. Fluid resuscitation and massive transfusion protocol should be activated when pelvic fracture patients are found in hypovolemic shock. At the emergency department, resuscitative endovascular balloon occlusion of the aorta may be performed to temporarily control bleeding. Finally, a damage control operation or trans-arterial embolization may be performed in the hybrid operating room.

Clinical and Health Economic Evaluation of a Novel Device for Fecal Management in Bedridden Patients.

Purpose: To evaluate the clinical effectiveness and health economic benefits of a novel indwelling lattice-based device for fecal management in bedridden patients. Materials and methods: This nonrandomized, two-arm study included 70 bedridden patients (≥18 years exhibiting liquid stool) referred from the ICU of surgery and medicine units of a 2000-bed tertiary care referral hospital, assigned to the intervention and control groups. About 35 patients were eligible to be included in the intervention group while 35 patients with contraindications to the intervention device were included in the usual care control group. Assessments were made before and every 24 hours during the study, and all patients were closely monitored for development of incontinence-associated dermatitis (IAD) and hospital-acquired pressure injury. Results: The test device was successfully deployed on the first attempt and effectively diverted fecal matter in all 35 patients, with no adverse events. In the control group, 83% of the patients developed IAD, which resulted in prolonged hospitalization and increased expenses. Overall, the control group (with adult diapers) required greater time, resources, and efforts for fecal management and resulted in increased patient morbidity. Conclusion: The patient management time, resource consumption, overall cost of hospital admission, and the complication rates are significantly lower with the use of the novel lattice-based device than with the use of adult diapers for fecal management. How to cite this article: Sheth H, Rao S, Karthik V. Clinical and Health Economic Evaluation of a Novel Device for Fecal Management in Bedridden Patients. Indian J Crit Care Med 2023;27(10):759-765.