Effect of endometrial scratching on unassisted conception for unexplained infertility: a randomized controlled trial.

OBJECTIVE: To investigate whether endometrial scratching increases the chance of live birth in women with unexplained infertility attempting to conceive without assisted reproductive technology. DESIGN: Randomized, placebo-controlled, participant-blind, multicenter international trial. SETTING: Fertility clinics. PATIENT(S): Women with a diagnosis of unexplained infertility trying to conceive without assistance. INTERVENTION(S): Participants were randomly assigned to receive an endometrial biopsy or a placebo procedure (placement of a biopsy catheter in the posterior fornix, without inserting it into the external cervical os). Both groups performed regular unprotected intercourse with the intention of conceiving over three consecutive study cycles. MAIN OUTCOME MEASURE(S): The primary outcome was live birth. RESULT(S): A total of 220 women underwent randomization. The live birth rate was 9% (10 of 113 women) in the endometrial-scratch group and 7% (7 of 107 women) in the control group (adjusted OR, 1.39; 95% CI, 0.50-4.03). There were no differences between the groups in the secondary outcomes of clinical pregnancy, viable pregnancy, ongoing pregnancy, and miscarriage. Endometrial scratching was associated with a higher pain score on a 10-point scale (adjusted mean difference, 3.07; 95% CI, 2.53-3.60). CONCLUSION(S): This trial did not find evidence that endometrial scratching improves the live birth rate in women with unexplained infertility trying to conceive without assistance. CLINICAL TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry ACTRN12614000656639.

Trucos y consejos para optimizar el tiempo de cateterización de arterias visceralesen dispositivos fenestrados (FEVAR) / Tips and tricks to optimize catheterization time of target vessel in fenestrated devices (FEVAR)

Introducción: el tratamiento de aneurismas complejos mediante FEVAR incluye entre sus objetivos un tiempoquirúrgico reducido para poder alcanzar el éxito técnico y clínico. Sin embargo, la canulación y el implante de losstents puente en múltiples arterias viscerales pueden suponer un factor limitante. Para evitar un tiempo de escopia y una dosis de radiación prolongados existen algunas maniobras que pueden ayudar a optimizar el tiempo de cateterización. Material y métodos: se realiza una revisión de los últimos casos tratados mediante endoprótesis fenestradas custom made de Zenith Cook® durante el año 2021 en un servicio de angiología, cirugía vascular y endovascular. El objetivo es mostrar las técnicas que sirven para optimizar el tratamiento de aneurismas complejos y que el cirujano puede emplear con el material habitual. Para ello se muestran varios fragmentos de vídeos de estos procedimientos grabados con el sistema OneView. Resultados: el primer paso clave consiste en la liberación del dispositivo fenestrado. La endoprótesis de Cook® presenta una o varias ligaduras de reducción que la mantienen fruncida hasta garantizar una correcta orientación y un correcto posicionamiento. Asimismo, ofrece la opción de canular las arterias viscerales entre la pared arterial y el dispositivo. Con una planifi cación adecuada y un abordaje sistematizado, el uso de guías coaxiales, catéteres de punta simple o reversa e introductores es esencial. El techo de la endoprótesis permite el avance de guías y de introductores con el soporte sufi ciente para su canulación. Los sistemas precargados permiten la canulación desde el miembro superior o el inferior. En este último caso, se utiliza una guía buddy de 0,014" que ofrece soporte al introductor, ya que lo acerca más aún a la fenestración, de tal modo que potencia el momento de torsión (torque) y el empuje del catéter.

Introduction: the treatment of complex aneurysms using FEVAR includes among its objectives a reduced surgicaltime in order to achieve technical and clinical success. However, cannulation and implantation of bridging stentsin multiple visceral arteries can be a limiting factor. To avoid a protracted scope time and radiation dose, there aresome maneuvers that can help optimize catheterization time. Material and methods: a review of the last cases treated with custom made Zenith Cook® fenestrated endoprostheses during the year 2021 is performed in an angiology, vascular and endovascular surgery service. The objective is to show video clips recorded with the OneView system of these techniques that the surgeon can use with the usual material to optimize the treatment of complex aneurysms.Results: the first key step is the release of the fenestrated device. The Cook® endoprosthesis has one or morereduction ligatures that keep it puckered until it guarantees correct orientation and positioning, as well as theoption of cannulating the visceral arteries between the arterial wall and the device.With proper planning and a systematic approach, the use of coaxial guides with single or reverse tip cathetersand introducers are essential. The roof of the endoprosthesis allows the advancement of guides and introducerswith sufficient support for their cannulation. The preloaded systems allow cannulation from the upper or lowerlimb. In the latter case, a 0.014” buddy guide is used to provide support for the introducer, bringing it even closerto fenestration in such a way as to enhance the torque and thrust of the catheter.

Insufficient procedural anticoagulation during leadless pacing led to catheter-related thrombosis in a hemodialysis patient.

BACKGROUND: Leadless pacemaker was a promising innovation than traditional transvenous pacemaker, the procedural complications were prone to be bleeding-related. However, very few reports also concerned about the thrombus formation during the procedure. CASE PRESENTATION: A hemodialysis patient with diabetic gangrene of right foot suffered from catheter-related thrombosis during leadless pacing, resulting in failure of recapture the pacemaker. A low activated clotting time (ACT) level of 104 s confirmed the insufficiency of anticoagulation. Finally, the whole delivery catheter had to be removed from the delivery sheath, another new pacemaker system was applied and successfully implanted after adjusting the ACT level to 248 s. CONCLUSION: Catheter-related thrombosis could be a large obstacle for leadless pacemaker implantation. In addition to routine anticoagulation, ACT monitoring might be necessary during the procedure.

Hydrogel-coated needles prevent puncture site bleeding in arteriovenous fistula and arteriovenous grafts in rats.

INTRODUCTION: Imperfect hemostasis after arteriovenous fistula (AVF) and arteriovenous graft (AVG) cannulation can cause a hematoma or pseudoaneurysm and leads to poor satisfaction. We hypothesized that a hydrogel-coated needle would effectively and rapidly stop bleeding after vascular cannulation in a rat AVF and AVG model. METHOD: A hydrogel comprised of sodium alginate (SA), hyaluronic acid (HA), and calcium carbonate was coated onto the surface of suture needles using a rotating system. The needles were observed using scanning electron microscopy (SEM) and immunofluorescence. Rat AVF with or without renal failure and AVG were punctured using bare and hydrogel-coated needles. The tissues were examined by histology. RESULT: The hydrogel was successfully coated onto the surface of 30 G needles and confirmed by SEM. Hydrogel-coated needles rapidly stopped bleeding after AVF and AVG cannulation in rat. CONCLUSION: In this preliminary animal research, hydrogel-coated needles can stop AVF and AVG puncture-site bleeding; but additional clinical studies are needed to justify whether it is still effective in clinical.

Falloposcopic tuboplasty: an easy, quick, and safe technique.

OBJECTIVE: To describe our simplified technique for falloposcopic tuboplasty (FT) and demonstrate its principle and results. DESIGN: A step-by-step description of the technique and demonstration of its principle using a clay model. SETTING: Private infertility clinics in Osaka and Tokyo operated by 10 physicians. PATIENT(S): A total of 431 infertile women with a diagnosis of unilateral or bilateral proximal tubal occlusion (6 cm from the uterotubal ostia), between October 2013 and February 2019 were included. These patients underwent routine work-ups for infertility, including a semen analysis, hysterosalpingography, antimüllerian hormone, basal luteinizing hormone/follicle-stimulating hormone and prolactin concentrations during menstruation, postcoital test in the periovulatory period, and estradiol and progesterone concentrations in the middle of the luteal phase. Physicians performed hysterosalpingography to evaluate tubal patency and uterine shape. Saline infusion sonography was not conducted because it does not accurately identify regions of tubal occlusion and/or stenosis. INTERVENTION(S): The principle of our simplified technique for FT is that a hole is located at the side of the FT catheter tip. Therefore, the balloon and fiberscope move away from the catheter line (Fig. 1). The uterotubal ostium is located at the tip-end of the triangle of the uterine cavity. When a balloon is inserted while visualizing the uterotubal ostium at the nearest position to the ostium, the balloon hits the uterine wall. When a balloon is inserted 5-10 mm from the uterotubal ostium without visualization, the balloon may be easily placed in the ostium through its convex angle, allowing it to slide into the uterine wall (Figs. 2 and 3). Step 1: Confirm anteflexion or retroflexion of the uterus by ultrasound. Step 2: Confirm the direction of the uterotubal ostia by hysteroscopy. Step 3: Adjust the angle of the FT catheter according to steps 1 and 2, insert the catheter into the end of the uterus, pull it back 5-10 mm (without visualizing the uterotubal ostia), and then fix it to the forceps. Catheter placement away from the tubal ostium is confirmed by the residual length of the moving part of the catheter. An attending instructor should ask the operator about the feeling of rigidity when the catheter does not advance and then suggest whether to proceed or stop. In the latter case, the catheter is not moved, saline is infused for 1 minute for lubrication, the balloon is pulled back using the fiberscope to remove the bunching of the balloon, and balloon pressure is changed as follows: 6→8→6→10→6 mmHg. Our institutional review board stated that approval was not required because the video describes the technique of our routine procedure. MAIN OUTCOME MEASURE(S): A description of the FT technique using a clay model and a demonstration of its application in our clinic. RESULT(S): The average operative time was 15.4 minutes, and the clinical pregnancy rate was 24.4% (natural conception and intrauterine insemination without in vitro fertilization). No significant differences were observed in the operative time or pregnancy rate among physicians. Approximately 17 FT procedures may be performed using one fiberscope. CONCLUSION(S): Our simplified technique, which was described and demonstrated in this video article, is a feasible and practical approach for performing FT. It provides excellent cost performance by saving fiberscopes. The most important point is "Introduce the balloon and fiberscope 5-10 mm away from the uterotubal ostia without visualizing it." To facilitate learning this technique, we recommend watching the video and then practicing FT without searching for the uterotubal ostia. Physicians master FT without any assistance by an attending instructor in ≤3 attempts.

Relationship Between the Loaded Pressure and Flow Rate of Packed Red Blood Cells and Various Infusion Solutions in Normal Infusion Lines and Catheters.

BACKGROUND: We investigated the relationship between the loaded pressure and flow rate in various catheters and the entire infusion line including the catheters, in several infusion solutions and packed red blood cells. METHODS: We connected the infusion line and catheter to the infusion solution and used an outer pressure bag or a compressor to pressurize the infusion solution bag to a pressure within the clinical (up to 450 mm Hg) or higher range (up to 1050 mm Hg). We approximated the relationship between the loaded pressure and flow rate in the entire infusion line including the catheter, versus the catheter alone, as a power function and compared the power numbers. RESULTS: In the clinical pressure range of normal saline, the power numbers of the entire infusion line for the 24-, 22-, 20-, and 18-gauge catheters were 0.76, 0.82, 0.81, and 0.86, respectively, while those for the catheter alone were 0.67, 0.63, 0.56, and 0.44, respectively. In the higher pressure range of normal saline, the power numbers of the entire infusion line for the 24-, 22-, 20-, and 18-gauge catheters were 0.68, 0.70, 0.71, and 0.73, respectively, while those for the catheter alone were 0.62, 0.61, 0.59, and 0.58, respectively. As the power number of the entire infusion line was closer to 1.00 than the values of the catheter, the relation between the loaded pressure and the flow rate was more linear in the entire infusion line than that in the catheter. Similar results were obtained using packed red blood cells and 40% glycerin mixture in normal saline. CONCLUSIONS: Regardless of the type of infusion solution or transfusion, the pressure-flow relationship in the catheter was nonlinear and not directly proportional. However, within the clinical pressure range (up to 450 mm Hg), the relationship between the flow rate and pressure in the entire infusion line was almost linear and proportional.

Comparison of catheter-over-needle and catheter-through-needle methods in ultrasound-guided continuous femoral nerve block: A prospective, randomized controlled trial.

BACKGROUND: The catheter-through-needle (CTN) method involves the insertion of a catheter with an outer diameter smaller than the initial puncture hole. We investigated whether the catheter-over-needle (CON) method is more effective than the CTN method in local anesthetic leakage at the catheter insertion site and catheter dislodgement, and how it affects postoperative pain management. METHODS: Seventy patients scheduled to undergo continuous femoral nerve block for pain control following total knee arthroplasty were enrolled and randomized to receive a perineural catheterization with either the CTN method (group CTN) or CON method (group CON). After ultrasound-guided catheterization, the transparent securement dressing was attached. The study compared the CON and CTN methods in terms of leakage at the catheter insertion site, catheter dislodgement, and postoperative analgesic efficacy for 48 hours postoperatively. RESULTS: Leakage at the catheter insertion site was significantly lower in the group CON (P < .05), while catheter dislodgement was not significantly different between the groups. The other adverse events were not different between the groups. The procedure time was significantly shorter in group CON (P < .05). No significant intergroup differences were observed 48 hours postoperatively in the visual analog scales, the number of patients requiring additional analgesics, and the number of times a bolus dose was injected with an injection pump. CONCLUSION: The CON method was able to shorten the procedure time while reducing the incidence of leakage at the catheter insertion site than the CTN method, and showed similar effects in postoperative pain management.

Left Transradial Neurointerventions Using the 6-French Simmons Guiding Sheath: Initial Experiences with the Interchange Technique.

BACKGROUND: The transradial approach using a Simmons-shaped catheter has been increasingly used for diagnostic cerebral angiography and neurointervention. In the transradial approach for neurointervention, the right radial artery is mainly used. However, in interventional cardiology, there are apparent clinical benefits with the left transradial approach for right-handed patients. To our knowledge, no studies have reported on neurointervention with the routine use of the left transradial approach. We therefore devised a novel technique for cases with an unachievable form of the Simmons shape using the standard technique, which we named the "interchange technique." The purpose of this study was to evaluate the technical feasibility of the left transradial neurointervention. METHODS: This study is a retrospective review of our prospective database of consecutive patients who underwent a left transradial neurointervention, using a 6-French Simmons guiding sheath, performed from January through April 2021. The outcome variables studied were successful catheterization and procedure-related complications. RESULTS: Twenty-one patients underwent a left transradial neurointervention including cerebral aneurysm coiling, carotid artery stenting, and meningioma embolization. The Simmons shape could not be formed with the standard technique for 3 patients, for whom we successfully formed the Simmons shape with our new interchange technique. The procedure was completely achieved in all 21 patients. No patients required crossover to the right radial or femoral arteries, and there were no radial artery spasms or occlusions or any procedural complications. CONCLUSIONS: The left transradial approach for neurointervention is a technically feasible, safe, and effective alternative while providing more comfort to right-handed patients.

Using naso- and oro-intestinal catheters in physiological research for intestinal delivery and sampling in vivo: practical and technical aspects to be considered.

Intestinal catheters have been used for decades in human nutrition, physiology, pharmacokinetics, and gut microbiome research, facilitating the delivery of compounds directly into the intestinal lumen or the aspiration of intestinal fluids in human subjects. Such research provides insights about (local) dynamic metabolic and other intestinal luminal processes, but working with catheters might pose challenges to biomedical researchers and clinicians. Here, we provide an overview of practical and technical aspects of applying naso- and oro-intestinal catheters for delivery of compounds and sampling luminal fluids from the jejunum, ileum, and colon in vivo. The recent literature was extensively reviewed, and combined with experiences and insights we gained through our own clinical trials. We included 60 studies that involved a total of 720 healthy subjects and 42 patients. Most of the studies investigated multiple intestinal regions (24 studies), followed by studies investigating only the jejunum (21 studies), ileum (13 studies), or colon (2 studies). The ileum and colon used to be relatively inaccessible regions in vivo. Custom-made state-of-the-art catheters are available with numerous options for the design, such as multiple lumina, side holes, and inflatable balloons for catheter progression or isolation of intestinal segments. These allow for multiple controlled sampling and compound delivery options in different intestinal regions. Intestinal catheters were often used for delivery (23 studies), sampling (10 studies), or both (27 studies). Sampling speed decreased with increasing distance from the sampling syringe to the specific intestinal segment (i.e., speed highest in duodenum, lowest in ileum/colon). No serious adverse events were reported in the literature, and a dropout rate of around 10% was found for these types of studies. This review is highly relevant for researchers who are active in various research areas and want to expand their research with the use of intestinal catheters in humans in vivo.

The Use of Chronic Total Occlusion (CTO) Wires for Perforation of Atretic Pulmonary Valve; Two Centers Experience.

Pulmonary valve atresia with intact ventricular septum (PA-IVS) can be treated either surgically or transcatheterly for eligible patients. Perforation of pulmonary valves using chronic total occlusion (CTO) guidewires has been reported as an alternative to radiofrequency (RF) perforation. We sought to report our experience with CTO guidewires for perforation of atretic pulmonary valves and subsequent balloon dilatation (with or without patent ductus arteriosus stenting) in patients with PA-IVS from two centers. A retrospective study was carried out on PA-IVS patients who underwent intervention between March 2014 and September 2019, in which CTO guidewire was employed for pulmonary valve perforation. A total of 26 patients were identified. The median age and weight of the patients were 5.2 days (range 1-21 days) and 3.1 kg (range 2.2-3.8 kg), respectively. All patients were situs solitus, except one patient with left atrial isomerism. The right ventricle (RV) morphology was bipartite in 22/26 patients and tripartite in 4/26 patients. Before the procedure, the mean saturation was 76% (range 70-86%) while the patients were under prostaglandin infusion. The pulmonary valve perforation attempt was performed with the Asahi Conquest Pro 9 CTO wire (n = 6) or Asahi Pro 12 CTO wire (n = 18) and/or Asahi Miracle CTO wire (n = 2). The procedure was successful in 20/26 (77%) patients using CTO wires. We analyzed the efficiency of CTO wire based on the subtypes: Conquest Pro 9 in 6/6 (100%) patients, Conquest Pro 12 in 12/18 (67%) patients, and Miracle in 2/2 (100%) patients. Before CTO wire usage in 3 patients, radiofrequency (RF) perforation was unsuccessful. Among these 3 patients, pulmonary valve perforation was successful in 2 patients with CTO wire; hence, in the remaining patient, perforation was also unsuccessful with CTO wire. After CTO wire perforation was unsuccessful in 6 patients, RF perforation was attempted in 3 patients (2 successful attempts and 1 unsuccessful attempts), and one patient as referred to surgery. Desaturation was persistent in 19 cases, which necessitated ductus arteriosus stenting. Early procedural complication was observed in 3/26 (11%) patients. Two of these patients had vascular complications due to the sheath, which was treated with heparin infusion and streptokinase, and the remaining patient had sudden bradycardia and cardiac arrest during the procedure and did not respond to cardiac resuscitation. CTO wires should be keep in mind for atretic pulmonary valve perforation as a first choice or when RF perforation is unsuccessful.

Through and Through Wire Technique for Stabilization of EVAR Main Body during Contralateral Limb Deployment.

Contralateral gate cannulation is one of the key steps of endovascular aortic aneurysm repair (EVAR), and multiple different techniques and tips have been described to ensure accurate and swift performance of this step. In some cases, a crossover approach, entailing an up-and-over wire access from the ipsilateral limb into the contralateral gate followed by snaring the wire to the contralateral groin and proceeding with contralateral limb deployment is needed. The risks with this technique include the necessity of completely deploying the stent-graft main body, ipsilateral limb, and release of its trigger wires which essentially render the graft untethered, and cause concerns about the graft migrating upwards or "buckling" during advancement of the contralateral limb in challenging anatomy. To overcome this issue, we describe a modification of this technique which involves retaining the through and through wire used for crossover cannulation as a stabilizing mechanism for the stent-graft and advancing a second "buddy wire" into the contralateral gate for deployment of the contralateral limb.

Performance assessment of intravenous catheters for massive transfusion: A pragmatic in vitro study.

BACKGROUND: Rapid infusion of warmed blood products is the cornerstone of trauma resuscitation and treatment of surgical and obstetric massive hemorrhage. Integral to optimizing this delivery is selection of an intravenous (IV) catheter and use of a rapid infusion device (RID). We investigated which IV catheter and RID system enabled the greatest infusion rate of blood products and the governing catheter characteristics. STUDY DESIGN AND METHODS: The maximum flow rates of nine IV catheters were measured while infusing a mixture of packed red blood cells and fresh frozen plasma at a 1:1 ratio using a RID with and without a patient line extension. To account for IV catheters that achieved the RID's maximum 1000 ml/min, the conductance of each infusion circuit configuration was calculated. RESULTS: IV catheters of 7-Fr caliber or higher reached the maximum pressurized flow rate. The 9-Fr multi-lumen access catheter (MAC) achieved the greatest conductance, over sevenfold greater than the 18 g peripheral catheter (4.6 vs. 0.6 ml/min/mmHg, p < .001). Conductance was positively correlated with internal radius (ß = 1.098, 95% CI 4.286-5.025, p < .001) and negatively correlated with length (ß= - 0.495, 95% CI -0.007 to 0.005, p < .001). Use of an extension line (ß= - 0.094, 95% CI -0.505 to -0.095, p = .005) was independently associated with reduced conductance in large caliber catheters. CONCLUSION: Short, large-diameter catheters provided the greatest infusion rates of massive transfusion blood products for the least pressure. For patients requiring the highest transfusion flow rates, extension tubing should be avoided when possible.

Salvage of Malfunctioning Peritoneal Dialysis Catheters: An Algorithm for Recanalization and Repositioning.

A peritoneal dialysis catheter salvage algorithm was developed and performed for 40 patients with documented catheter malfunction (obstruction and/or malposition) referred to the interventional radiology suite. This procedure utilized a metallic stiffener for repositioning and rotating dual guide wires for recanalization. A retrospective analysis of 35 cases of fluoroscopic manipulation showed that in 83% of the cases, the catheters were successfully repositioned and/or recanalized, and in 59%, they remained patent at 30 days. No major adverse events occurred. The results suggest that this algorithm is a safe and effective approach to salvage malfunctioning peritoneal dialysis catheters and that a trial of fluoroscopic salvage can be considered prior to surgical intervention.

Utilization potential of intraluminal optical coherence tomography for the Eustachian tube.

Imaging the Eustachian tube is challenging because of its complex anatomy and limited accessibility. This study fabricated a fiber-based optical coherence tomography (OCT) catheter and investigated its potential for assessing the Eustachian tube anatomy. A customized OCT system and an imaging catheter, termed the Eustachian OCT, were developed for visualizing the Eustachian tube. Three male swine cadaver heads were used to study OCT image acquisition and for subsequent histologic correlation. The imaging catheter was introduced through the nasopharyngeal opening and reached toward the middle ear. The OCT images were acquired from the superior to the nasopharyngeal opening before and after Eustachian tube balloon dilatation. The histological anatomy of the Eustachian tube was compared with corresponding OCT images, The new, Eustachian OCT catheter was successfully inserted in the tubal lumen without damage. Cross-sectional images of the tube were successfully obtained, and the margins of the anatomical structures including cartilage, mucosa lining, and fat could be successfully delineated. After balloon dilatation, the expansion of the cross-sectional area could be identified from the OCT images. Using the OCT technique to assess the Eustachian tube anatomy was shown to be feasible, and the fabricated OCT image catheter was determined to be suitable for Eustachian tube assessment.

Cannula breakage during 25G+ minimally invasive vitrectomy: a case report.

BACKGROUND: With the continuous improvement of surgical instruments in vitrectomy, the use of a trocar and cannula not only optimizes the incision process but also facilitates insertion and withdrawal of instruments during the procedure. Nevertheless, incision-related complications have also been reported in the literature. However, cannula fractures during 25G+ minimally invasive vitrectomy have rarely been reported. CASE PRESENTATION: A 62-year-old man underwent 25G+ pars plana vitrectomy for proliferative diabetic retinopathy. At the beginning of the operation, we used a trocar with a cannula to perform the sclerotomy. After the trocar was pulled out, the cannula was not seen on the surface of the sclera. Thus the inside and outside of the eye were carefully searched. The broken cannula tip was found in the ciliary body corresponding to the superonasal sclerotomy site and was subsequently removed. CONCLUSIONS: Awareness regarding the risk of intraoperative fractures of 25G+ minimally invasive ocular surgical instruments is imperative. Whenever a broken or missing cannula is encountered, the residual part should be immediately extracted to avoid revision surgeries and postoperative complications.

Novel Dual-Lumen Drainage Catheter to Enhance the Active Evacuation of Complex Fluid Collections.

PURPOSE: To compare the performance of a dual-lumen flushable drainage catheter to a conventional catheter for complex fluid collection drainage. METHODS: Two prototype catheters (20- and 28-F) were created by incorporating a customized infusion lumen within the wall of a large-bore conventional drainage catheter, which facilitated simultaneous irrigation of the drainage lumen and the targeted collection via inward- and outward-facing infusion side holes. These were tested against unaltered 20- and 28-F conventional catheters to determine if the injection of a dedicated flush lumen improved rapidity and completeness of gravity drainage. In vitro models were created to simulate serous fluid, purulent/exudative fluid, particulate debris, and acute hematoma. RESULTS: In the purulent model, mean drainage rate was 19.9 ± 8.0 and 9.5±1.4 mL/min for the 20-F prototype and control (P < .001) and 63.9 ± 4.3 and 35.4 ± 3.4 mL/min for the 28-F prototype and control (P = .006), respectively, with complete drainage achieved in all trials. In the particulate model, mean drainage rate was 24.5 ± 9.7 and 12.0 ± 12.5 mL/min for the 28-F prototype and control (P = .003), respectively, with 69.0% versus 41.1% total drainage achieved over 24 minutes (P = .029). In the hematoma model, mean drainage rate was 22.7 ± 4.6 and 4.8 ± 4.3 mL/min for the 28-F prototype and control (P = .022), respectively, with 80.3% versus 20.1% drainage achieved over 15 minutes (P = .003). Particulate and hematoma 20-F prototypes and conventional trials failed due to immediate occlusion. CONCLUSIONS: The proposed dual-lumen drainage catheter with irrigation of a dedicated flush lumen improved evacuation of complex fluid collections in vitro.

Six versus twelve hours of single-balloon catheter placement with oxytocin administration for labor induction: a randomized controlled trial.

BACKGROUND: Induction of labor is common in the United States. Multiple previous studies have tried to outline a faster time to delivery to improve maternal and fetal outcomes. OBJECTIVE: This study aimed to evaluate whether women who undergo induction of labor with a single-balloon catheter and oxytocin have a shorter time to delivery with planned removal of the catheter at 6 vs 12 hours. STUDY DESIGN: In this randomized controlled trial, induction of labor was performed using a combination of single-balloon catheter and oxytocin. Term women, both nulliparous and multiparous, aged 18 to 50 years old with cephalic singletons were included if they were undergoing induction of labor with a Bishop score of <6 and cervical dilation of <2 cm. Women were randomized to planned removal of the single-balloon catheter at 6 hours vs 12 hours. The primary outcome was time from catheter insertion to delivery. We were powered to show a 4-hour time difference with a sample size of 89 women per group (n=178). Planned sensitivity analyses were performed to account for cesarean delivery in labor. RESULTS: From February 2019 to June 2020, 237 women were screened, 178 women were randomized, and 177 women were included in the final analysis (89 women in the 6-hour group and 88 women in the 12-hour group). Insertion to delivery time was significantly shorter in the 6-hour group (19.2 vs 24.3 hours; P=.04), and the proportion of women delivered by 24 hours was significantly greater in the 6-hour group (67.4% vs 47.4%; P<.01). There was no difference in the Bishop score at removal of the catheter or secondary maternal or neonatal outcomes. In a Cox proportional-hazards model censoring for cesarean delivery, the 6-hour group had a significantly shorter insertion to delivery time (hazard ratio, 0.67; P=.02). CONCLUSION: Induction of labor with a single-balloon catheter and oxytocin with planned removal of the catheter at 6 hours rather than 12 hours results in a shorter time from insertion to delivery without increasing the rate of cesarean delivery. Decreasing the length of time a single-balloon catheter is in place should be considered in clinical protocols.