CAP Trial Research Articles

MP17-05 PROSPECTIVE CLINICAL TRIAL EVALUATING ANTEGRADE NEPHROSTOGRAPHY TO ASSESS URINE FLOW AFTER PERCUTANEOUS NEPHROLITHOTOMY

INTRODUCTION AND OBJECTIVES: Percutaneous nephrolithotomy (PNL) remains an effective treatment for patients with a large stone burden. When a nephrostomy tube (NT) is left in place postoperatively, antegrade flow of urine is often confirmed with antegrade nephrostography (ANG) as edema from a chronically obstructing stone can resolve in variable amounts of time. Alternatively, antegrade flow can be estimated by injecting methylene blue dye into the NT or performing a NT capping trial. We compared the methylene blue dye test and capping trial against ANG to assess antegrade urine flow. METHODS: Consecutive patients undergoing PNL at 2 hospitals were prospectively enrolled between July and October, 2014. A cap was placed on the NT on the morning of postoperative day 1 (POD1). Capping trial failure was defined as need to uncap NT for any reason including increased pain or fever. 2 hours after capping, 7cc of methylene blue was injected into the NT and the tube recapped. Positive test was defined as the presence of blue per urethral Foley. Later that afternoon, ANG was performed to radiographically document antegrade urine flow. Sensitivity, specificity, positive (PPV) and negative predictive values (NPV) were calculated comparing capping and methylene blue tests against ANG. RESULTS: 34 subjects underwent PNL. 55.9% were left sided and 73.5% were lower pole punctures (mean age 54.9 13.9 years; mean BMI 31.7 12.7kg/m2; mean stone size 2.86 1.42cm). Capping trial was successful in 86.7% of patients. Compared to ANG, it had a sensitivity of 94.4% (CI 83.9-100%), specificity 25.0% (CI 0.5-49.5%), PPV 65.4% (47.1-83.7%), and NPV 75.0% (CI 32.6-100%) to predict antegrade urine flow. The methylene blue test was positive in 41.4% of patients. Compared to ANG, it had a sensitivity of 52.9% (CI 29.2-76.7%), specificity 75.0% (CI 50.5-99.5%), PPV 75.0% (CI 50.5-99.5%), and NPV 52.9% (CI 29.2-76.7%) to predict antegrade urine flow. CONCLUSIONS: Compared to ANG, a capping trial and methylene blue test are 94% and 53% sensitive and 25% and 75% specific respectively for confirming antegrade urine flow following PNL. In clinical practice, these tests may potentially be used in combination to obviate the need for ANG, which can be redundant and timeconsuming.

Design and preliminary recruitment results of the Cluster randomised triAl of PSA testing for Prostate cancer (CAP).

Background:Screening for prostate cancer continues to generate controversy because of concerns about over-diagnosis and unnecessary treatment. We describe the rationale, design and recruitment of the Cluster randomised triAl of PSA testing for Prostate cancer (CAP) trial, a UK-wide cluster randomised controlled trial investigating the effectiveness and cost-effectiveness of prostate-specific antigen (PSA) testing.Methods:Seven hundred and eighty-five general practitioner (GP) practices in England and Wales were randomised to a population-based PSA testing or standard care and then approached for consent to participate. In the intervention arm, men aged 50–69 years were invited to undergo PSA testing, and those diagnosed with localised prostate cancer were invited into a treatment trial. Control arm practices undertook standard UK management. All men were flagged with the Health and Social Care Information Centre for deaths and cancer registrations. The primary outcome is prostate cancer mortality at a median 10-year-follow-up.Results:Among randomised practices, 271 (68%) in the intervention arm (198 114 men) and 302 (78%) in the control arm (221 929 men) consented to participate, meeting pre-specified power requirements. There was little evidence of differences between trial arms in measured baseline characteristics of the consenting GP practices (or men within those practices).Conclusions:The CAP trial successfully met its recruitment targets and will make an important contribution to international understanding of PSA-based prostate cancer screening.

Utilization of a standardized tracheostomy capping and decannulation protocol to improve patient safety

To develop and assess the feasibility of a new standardized protocol to guide tracheostomy decannulation. Descriptive review of quality improvement project. A quality improvement project was conducted in the inpatient setting of a tertiary urban academic hospital. Adult patients who had received a tracheostomy and for whom the indication for tracheostomy had resolved were included. A multidisciplinary task force reviewed input from clinicians caring for tracheostomy patients and developed a protocol for screening, capping, and decannulation. The primary outcome measured was successful decannulation. Fifty-seven patients were screened for a capping trial over a 12-month period; 54 were capped. Six patients were lost to follow-up. Fifty patients passed the capping trial, and all 50 were decannulated successfully. When decannulation was pursued in one patient who had twice failed the screening criteria and subsequent capping trials, the patient failed decannulation and ultimately required reintubation for the management of secretions. The screening tool had high sensitivity (90%) and positive predictive value (100%) for successful decannulation. Additionally, the number of reported patient safety concerns decreased from seven in the 6 months preceding implementation of the program to one report in the 6 months after implementation. The new tracheostomy capping and decannulation protocol assisted in predicting both successful and failed decannulation. Although several patients failed certain capping criteria initially, the protocol stipulated modifications of care that enabled successful decannulation. The screening tool had high sensitivity and promoted communication, standardization of practice, and patient safety.

Central Venous Catheter Protective Connector Caps Reduce Intraluminal Catheter-Related Infection

BackgroundCentral line-associated blood stream infection (CLABSI) rates in adult care intensive care units have been decreasing across the board. However, we continued to see just a few infections in patients whose catheters are in for >4 days. Therefore, we looked at infections associated with intraluminal contamination to help reduce our infection rate. MethodsA protective cap trial was developed and implemented in 2 intensive care units. All of the central venous catheter and intravenous tubing access valves were covered with a protective cap saturated with alcohol. This intervention eliminated the need to wipe off intravenous access points with an alcohol swab. The study was done as a nonrandomized prospective trial occurring March 1, 2011 through February 29, 2012. ResultsDuring 2010, there were 4 CLABSI-related infections. By the end of the trial, we had incurred 1 catheter-associated blood stream infection. CLABSI rate reduced from 1.9 in 2010 to 0.5 during the 1-year trial period. ConclusionsThe implementation of the port protector cap system resulted in lower infection rates compared with an alcohol swab technique. Our results indicate that consistent use of the caps in tandem with strict compliance does influence CLABSI rates.

329 Severe Retinopathy of Prematurity (ROP) Remains a Marker of Childhood Disabilities: Results from the Caffeine for Apnea of Prematurity Trial

BackgroundThe Cryotherapy for Retinopathy of Prematurity Cooperative Group showed that the severity of ROP was a marker for functional disability at 5.5 years in infants ≤1250 g BW who were...

386 A Count of three Neonatal Morbidities may Substitute for Long-Term Neurodevelopmental follow-up in very Low Birth Weight (VLBW) Infants

BackgroundIn very preterm infants who survive to a postmenstrual age (PMA) of 36 weeks, a count of BPD, brain injury and severe ROP predicts the risk of a later death...

Subacute Airway Obstruction Caused by a Suprastomal Tracheal Granuloma following Tracheotomy in an Adult

We report a case of a post-tracheotomy suprastomal granuloma in the early postoperative phase that caused subacute airway obstruction in a 28-year-old woman. The patient had undergone the tracheotomy during the surgical treatment of a submental abscess. During recovery, several capping trials had failed. Therefore, direct laryngoscopy was performed on postoperative day 11, and it revealed that the airway was being obstructed by a tracheal granuloma. The granuloma was managed with a partial resection and corticosteroids. The patient was successfully decannulated with no recurrence of the granuloma. To the best of our knowledge, airway obstruction secondary to a tracheal granuloma has not been previously reported as an early complication of a traditional surgical tracheotomy in an adult. In this report, we discuss the presenting features of this case and we propose several possible etiologies.

Prophylactic methylxanthines for endotracheal extubation in preterm infants

Weaning and extubating preterm infants on intermittent positive pressure ventilation (IPPV) for respiratory failure may be difficult. A significant contributing factor is thought to be the relatively poor respiratory drive and tendency to develop hypercarbia and apnoea, particularly in very preterm infants. Methylxanthine treatment started before extubation might stimulate breathing and increase the chances of successful weaning from IPPV. To determine the effects of prophylactic methylxanthine treatment on the use of intubation and IPPV and other clinically important side effects in preterm infants being weaned from IPPV and in whom endotracheal extubation is planned. The standard search strategy of the Cochrane Neonatal Review Group was used. This included searches of The Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 2, 2010), the Oxford Database of Perinatal Trials, MEDLINE (1966 to July 2010), CINAHL (1982 to July 2010) and EMBASE (1988 to July 2010). All published trials utilising random or quasi-random patient allocation in which treatment with methylxanthines (theophylline or caffeine) was compared with placebo or no treatment to improve the chances of successful extubation of preterm or low birth weight infants were included. The standard methods of the Cochrane Collaboration and its Neonatal Review Group were used. Seven studies were identified for inclusion. Methylxanthine treatment results in a reduction in failure of extubation within one week (summary RR 0.48, 95%CI 0.32 to 0.71; summary RD -0.27, 95%CI -0.39 to -0.15; NNT 4, 95%CI 3 to 7; six trials, 172 infants). There is significant heterogeneity in the RD meta-analysis perhaps related to the large variation in baseline rate in the control groups (range 20 to 100%).The CAP trial enrolled the largest number of infants, but did not report extubation rates. In the caffeine group, there were lower rates of bronchopulmonary dysplasia, PDA ligation, cerebral palsy and death or major disability at 18 to 21 months. Infants receiving caffeine had reduced postmenstrual ages at time of discontinuing oxygen therapy, positive pressure ventilation and endotracheal intubation. Methylxanthines increase the chances of successful extubation of preterm infants within one week of age. Important neurodevelopmental outcomes are improved by methylxanthine therapy. In any future trials, there is a need to stratify infants by gestational age (a better indicator of immaturity than birth weight). Caffeine, with its wider therapeutic margin, would be the better treatment to evaluate against placebo.

Hypothermia for neonatal encephalopathy - a refinement

There have now been two large trials demonstrating that 72h of hypothermia may improve the neurodevelopment outcomes of infants with neonatal encephalopathy. Only infants with moderate encephalopathy after birth seem to benefit. Few infants with mild encephalopathy have long-term deficits and the severe cases appear to have no benefit. There are ongoing trials, which will better inform us about this therapy, but multiple questions will remain. For example, there is no information in humans about the interval from birth to initiation of cooling that can protect the brain, the optimal temperature, or the optional duration of cooling. Trials of cooling for neonatal encephalopathy are very difficult. Most of these infants are born outside level 3 units capable of providing hypothermia, and the clinical assessments for the hypothermia, consent, and initiation of therapy within 6h of birth limits enrollment in trials. Careful in-depth analysis of the limited available data can provide some information to guide clinical care. In this issue of The Journal, Gunn et al provide a secondary analysis of the Cool Cap Trial, which demonstrates that the degree of encephalopathy is not altered by hypothermia on day 4. This information indicates that a therapeutic response cannot be evaluated by the clinical exam. As previously reported, infants with moderate encephalopathy are most likely to benefit. There have now been two large trials demonstrating that 72h of hypothermia may improve the neurodevelopment outcomes of infants with neonatal encephalopathy. Only infants with moderate encephalopathy after birth seem to benefit. Few infants with mild encephalopathy have long-term deficits and the severe cases appear to have no benefit. There are ongoing trials, which will better inform us about this therapy, but multiple questions will remain. For example, there is no information in humans about the interval from birth to initiation of cooling that can protect the brain, the optimal temperature, or the optional duration of cooling. Trials of cooling for neonatal encephalopathy are very difficult. Most of these infants are born outside level 3 units capable of providing hypothermia, and the clinical assessments for the hypothermia, consent, and initiation of therapy within 6h of birth limits enrollment in trials. Careful in-depth analysis of the limited available data can provide some information to guide clinical care. In this issue of The Journal, Gunn et al provide a secondary analysis of the Cool Cap Trial, which demonstrates that the degree of encephalopathy is not altered by hypothermia on day 4. This information indicates that a therapeutic response cannot be evaluated by the clinical exam. As previously reported, infants with moderate encephalopathy are most likely to benefit. Therapeutic Hypothermia Changes the Prognostic Value of Clinical Evaluation of Neonatal EncephalopathyThe Journal of PediatricsVol. 152Issue 1PreviewTo evaluate whether therapeutic hypothermia alters the prognostic value of clinical grading of neonatal encephalopathy. Full-Text PDF

A randomized trial comparing compression, perclose proglide™ and Angio‐Seal VIP™ for arterial closure following percutaneous coronary intervention: The cap trial

This prospective randomized trial compared the Angio-Seal VIP with Perclose Proglide and to manual compression with respect to time to hemostasis and ambulation, patient satisfaction, and vascular complications following percutaneous coronary intervention (PCI). The use of arterial closure devices for the reduction of vascular complications following PCI remains controversial. There have been no head to head trials comparing these most commonly used arterial closure devices following PCI. Two hundred patients undergoing PCI were randomized to manual compression, Perclose Proglide or Angio-Seal VIP. Ambulation was allowed 3 hr after Perclose Proglide or Angio-Seal VIP and 6 hr after compression. There were 10 failures to deploy Perclose Proglide and none for Angio-Sealt (P < 0.01). Time to hemostasis was significantly shorter with Angio-Seal VIP compared with Perclose Proglide (5.3 vs. 46.8 min, P < 0.01). Time to ambulation was shorter with Angio-Seal VIP than with Perclose Proglide (261 vs. 334 min, P < 0.05) and the time to ambulation, as expected, was longest with compression (943 min, P < 0.01 vs. Angio-Seal VIP and Perclose Proglide). Delay in ambulation was higher with Perclose Proglide than with Angio-Seal VIP (18 vs. 9, P < 0.01). There was no significant difference in major vascular complications between groups. Compared with compression, patient discomfort was significantly improved with Angio-Seal (1.5 vs. 2.0, P < 0.01), but not with Perclose Proglide. The Angio-Seal VIPtrade mark device has a high rate of deployment success, which is significantly better than that of Perclose Proglide. Angio-Seal VIP allows for earlier hemostasis and ambulation compared with both compression and Perclose Proglide and is associated with greater patient satisfaction compared with compression.

Field and Laboratory Assessment of Lime-Based Mortars

Mortar capping trials carried out at Corfe Castle by the National Trust have been monitored closely over the past seven years. These have appraised a range of hydraulic and high-calcium limes. The objectives of the trials have been to explore and promote the materials commonly described in historical literature and used in traditional building practice. A parallel programme of laboratory characterization of the physical properties of similar mixes has been carried out by BRE Limited.The trials were applied to a very high standard of design and workmanship in a context of harsh weather exposure. Good durability is evidenced by the hydraulic limes, mixes of hydraulic and high-calcium limes, and high-calcium lime with sufficient reactive set-additive or pozzolans. High-calcium lime mortars and those with less reactive set-additives showed early failure. These substantiate the claim in most historical literature that the durability of different lime mortars is variable, and it is necessary to specify them according to the demands of the context of application.