A 2 × 2 factorial, randomised, open-label trial to determine the clinical and cost-effectiveness of hypertonic saline (HTS 6%) and carbocisteine for airway clearance versus usual care over 52 weeks in adults with bronchiectasis: a protocol for the CLEAR clinical trial.

BACKGROUND: Current guidelines for the management of bronchiectasis (BE) highlight the lack of evidence to recommend mucoactive agents, such as hypertonic saline (HTS) and carbocisteine, to aid sputum removal as part of standard care. We hypothesise that mucoactive agents (HTS or carbocisteine, or a combination) are effective in reducing exacerbations over a 52-week period, compared to usual care. METHODS: This is a 52-week, 2 × 2 factorial, randomized, open-label trial to determine the clinical effectiveness and cost effectiveness of HTS 6% and carbocisteine for airway clearance versus usual care - the Clinical and cost-effectiveness of hypertonic saline (HTS 6%) and carbocisteine for airway clearance versus usual care (CLEAR) trial. Patients will be randomised to (1) standard care and twice-daily nebulised HTS (6%), (2) standard care and carbocisteine (750 mg three times per day until visit 3, reducing to 750 mg twice per day), (3) standard care and combination of twice-daily nebulised HTS and carbocisteine, or (4) standard care. The primary outcome is the mean number of exacerbations over 52 weeks. Key inclusion criteria are as follows: adults with a diagnosis of BE on computed tomography, BE as the primary respiratory diagnosis, and two or more pulmonary exacerbations in the last year requiring antibiotics and production of daily sputum. DISCUSSION: This trial's pragmatic research design avoids the significant costs associated with double-blind trials whilst optimising rigour in other areas of trial delivery. The CLEAR trial will provide evidence as to whether HTS, carbocisteine or both are effective and cost effective for patients with BE. TRIAL REGISTRATION: EudraCT number: 2017-000664-14 (first entered in the database on 20 October 2017). ISRCTN.com, ISRCTN89040295. Registered on 6 July/2018. Funder: National Institute for Health Research, Health Technology Assessment Programme (15/100/01). SPONSOR: Belfast Health and Social Care Trust. Ethics Reference Number: 17/NE/0339. Protocol version: v3.0 Final_14052018.

Efficacy, Effectiveness, Safety, and Cost-effectiveness of Epidural Adhesiolysis for Treating Failed Back Surgery Syndrome. A Systematic Review.

BACKGROUND: Failed back surgery syndrome (FBSS) has a profound impact on patients' quality of life and represents a major clinical challenge and a significant economic burden for society. Adhesiolysis is used as a treatment to eliminate perineural/epidural adhesions in patients with chronic pain attributed to FBSS. OBJECTIVE: To evaluate the efficacy, effectiveness, safety, and cost-effectiveness of epidural adhesiolysis compared with other procedures for treating FBSS. METHOD: A systematic review was conducted. The electronic databases Medline/PreMedline, EMBASE, Cochrane Library Plus, Centre for Reviews and Dissemination databases, SCOPUS, Science Citation Index, and PEDRO were consulted through April 2017. Predefined criteria were used to determine inclusion of the studies and to assess their methodological quality. RESULTS: Ten reports were included. No randomized controlled trials (RCTs) on efficacy or cost-effectiveness were found. Three reports (corresponding to two RCTs, N = 212) suggested that adhesiolysis was effective, especially for pain and disability. However, both studies presented serious methodological flaws. In addition to RCTs, seven observational studies with high risk of bias reported data on effectiveness and safety. Fifty-eight adverse events were reported among 130 patients undergoing endoscopic adhesiolysis, and 19 among the 110 undergoing percutaneous adhesiolysis. CONCLUSIONS: The evidence on the efficacy and cost-effectiveness of adhesiolysis for treating FBSS is nonexistent, whereas evidence on its effectiveness and safety is insufficient. Incorporating data from observational studies did not improve the quality of the evidence on effectiveness.

The cost-effectiveness of hypertonic saline inhalations for infant bronchiolitis: a decision analysis.

BACKGROUND: This study evaluated the cost-effectiveness of hypertonic saline (HS) inhalations for infant bronchiolitis, compared to normal saline inhalations or standard treatment without inhalations as controls. METHODS: The decision tree in the decision analysis was used to calculate the expected costs. Actual cost data were obtained from our retrospective case-control study on bronchiolitis treatment. The effectiveness of treatment, based on the hospitalization rate of those admitted to the emergency department and the length of stay (LOS) of those who were hospitalized, was collected from previous studies. For the effectiveness estimations, we made a meta-analysis summarizing the results of the meta-analysis of the Cochrane review in 2013 and the results of 10 studies published after it. RESULTS: The mean hospitalization rate was 24.7% in the HS inhalation group and 32.6% in the control group [risk ratio: 0.80, 95% confidence interval (CI) 0.67-0.96] and the mean LOS was 3.736 (HS group) and 4.292 (controls) days (mean difference: - 0.55 days, 95% CI - 0.96 to - 0.15), respectively. The expected costs per patient, when both inpatients and outpatients were included, were €816 ($1111) in the HS inhalation group and €962 ($1310) in the control group. The expected costs per hospitalization, when only inpatients were included, were €2600 ($3540) in the HS inhalation group and €2890 ($3935) in the control group. CONCLUSIONS: HS inhalations slightly reduced the expected hospitalization costs of infant bronchiolitis. However, the low effectiveness, rather than the cost, is the factor that will limit the use of HS inhalations in infant bronchiolitis.

Comparison of salt with low-dose furosemide and carperitide for treating acute decompensated heart failure: a single-center retrospective cohort study.

Hypertonic saline with furosemide has been proposed for a long time as an effective therapeutic option for the treatment of acute decompensated heart failure (ADHF). We previously reported the efficacy of continuous infusion of 1.7 % hypertonic saline plus low-dose furosemide in treatment for ADHF. Although this therapeutic strategy can be a useful option for effective decongestion in treatment for ADHF, there is no study that assesses the effect and safety of saline supplementation compared with standard therapy in Japan. The aim of this study was to investigate the efficacy, safety, and cost-effectiveness of 1.7 % hypertonic saline plus low-dose furosemide infusion compared with carperitide. We compared clinical outcomes, adverse events, and cost for patients receiving carperitide (carperitide group) with those for patients receiving 1.7 % hypertonic saline plus low-dose furosemide (salt group) during the initial hospitalization for ADHF. The cost analysis was performed on the basis of the previous report about cost-effectiveness of acute heart failure. A total of 175 ADHF patients received either carperitide (n = 111) or 1.7 % hypertonic saline plus low-dose furosemide infusion (n = 64) as initial treatment. There were no differences in length of hospital stay (27 ± 19 vs. 25 ± 16 day, p = 0.170) and infusion period (7.2 ± 6.1 vs. 8.4 ± 7.5 day, p = 0.474) between the two groups. The incidence of rehospitalization did not differ at 1 month (7.6 vs. 6.6 %, p = 1.000) and 1 year (36.8 vs. 37.7 %, p = 0.907) between the two groups. The Kaplan-Meier curves revealed no significant difference for 1 year all-cause mortality between the two groups (log-rank, p = 0.724). The single hospitalization cost was 95,314 yen lower and the yearly hospitalization cost 125,628 yen lower in the salt group compared with the carperitide group. Thus, intravenous 1.7 % hypertonic saline plus low-dose furosemide infusion is as effective as carperitide in terms of clinical outcome and is a cost-effective therapeutic strategy for the treatment of ADHF.

Saline in acute bronchiolitis RCT and economic evaluation: hypertonic saline in acute bronchiolitis - randomised controlled trial and systematic review.

BACKGROUND: Acute bronchiolitis is the most common cause of hospitalisation in infancy. Supportive care and oxygen are the cornerstones of management. A Cochrane review concluded that the use of nebulised 3% hypertonic saline (HS) may significantly reduce the duration of hospitalisation. OBJECTIVE: To test the hypothesis that HS reduces the time to when infants were assessed as being fit for discharge, defined as in air with saturations of > 92% for 6 hours, by 25%. DESIGN: Parallel-group, pragmatic randomised controlled trial, cost-utility analysis and systematic review. SETTING: Ten UK hospitals. PARTICIPANTS: Infants with acute bronchiolitis requiring oxygen therapy were allocated within 4 hours of admission. INTERVENTIONS: Supportive care with oxygen as required, minimal handling and fluid administration as appropriate to the severity of the disease, 3% nebulised HS every ± 6 hours. MAIN OUTCOME MEASURES: The trial primary outcome was time until the infant met objective discharge criteria. Secondary end points included time to discharge and adverse events. The costs analysed related to length of stay (LoS), readmissions, nebulised saline and other NHS resource use. Quality-adjusted life-years (QALYs) were estimated using an existing utility decrement derived for hospitalisation in children, together with the time spent in hospital in the trial. DATA SOURCES: We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and other databases from inception or from 2010 onwards, searched ClinicalTrials.gov and other registries and hand-searched Chest, Paediatrics and Journal of Paediatrics to January 2015. REVIEW METHODS: We included randomised/quasi-randomised trials which compared HS versus saline (± adjunct treatment) or no treatment. We used a fixed-effects model to combine mean differences for LoS and assessed statistical heterogeneity using the I (2) statistic. RESULTS: The trial randomised 158 infants to HS (n = 141 analysed) and 159 to standard care (n = 149 analysed). There was no difference between the two arms in the time to being declared fit for discharge [median 76.6 vs. 75.9 hours, hazard ratio (HR) 0.95, 95% confidence interval (CI) 0.75 to 1.20] or to actual discharge (median 88.5 vs. 88.7 hours, HR 0.97, 95% CI 0.76 to 1.23). There was no difference in adverse events. One infant developed bradycardia with desaturation associated with HS. Mean hospital costs were £2595 and £2727 for the control and intervention groups, respectively (p = 0.657). Incremental QALYs were 0.0000175 (p = 0.757). An incremental cost-effectiveness ratio of £7.6M per QALY gained was not appreciably altered by sensitivity analyses. The systematic review comprised 15 trials (n = 1922) including our own. HS reduced the mean LoS by -0.36 days (95% CI -0.50 to -0.22 days). High levels of heterogeneity (I (2) = 78%) indicate that the result should be treated cautiously. CONCLUSIONS: In this trial, HS had no clinical benefit on LoS or readiness for discharge and was not a cost-effective treatment for acute bronchiolitis. Claims that HS achieves small reductions in LoS must be treated with scepticism. FUTURE WORK: Well-powered randomised controlled trials of high-flow oxygen are needed. STUDY REGISTRATION: This study is registered as NCT01469845 and CRD42014007569. FUNDING DETAILS: This project was funded by the NIHR Health Technology Assessment (HTA) programme and will be published in full in Health Technology Assessment; Vol. 19, No. 66. See the HTA programme website for further project information.

Computerized Assessment of Wheezing in Children With Respiratory Syncytial Virus Bronchiolitis Before and After Hypertonic Saline Nebulization.

BACKGROUND: Studies suggest an effect of nebulized hypertonic saline solution on air-flow limitation in subjects with respiratory syncytial virus (RSV) bronchiolitis, but results are based on subjective scores of clinical severity and are not clear. In this observational study, we used a noninvasive computerized tool to quantify wheezing before and after nebulization with hypertonic saline in children admitted for RSV infection. METHODS: Twenty-seven children (≤ 24 months old) admitted to the pediatric ward of the Medical Center Leeuwarden with polymerase chain reaction-confirmed RSV bronchiolitis were included. Subjects were simultaneously assessed both clinically and by computerized acoustic monitoring before and 15 min after treatment with nebulized hypertonic saline solution. RESULTS: Clinical assessment, defined by the Respiratory Distress Assessment Instrument score, did not change after nebulization (n = 27, 5.0 vs 4.7, P = .17). Computerized acoustic monitoring showed no improvement in wheezing (n = 27, 3.4% vs 2.0%, P = .05) or inspiration/expiration ratio (0.85 vs 0.85, P = .93) after nebulization. CONCLUSIONS: Hypertonic saline nebulization does not improve air flow, as assessed by both clinical and computerized acoustic scores, in children admitted for RSV.

[Inhaled treatments in cystic fibrosis: what's new in 2013?]. / Mucoviscidose et traitements inhalés: quoi de neuf en 2013?

In the past few years some new inhaled drugs and inhalation devices have been proposed for the treatment of cystic fibrosis. Breath-controlled nebulizers allow increased pulmonary deposition, with a lower variability and a shorter delivery time. The new dry powder formulations of tobramycin, colistine and mannitol require a change in the inhalation technique which must be slow and deep. In the field of the inhaled mucolytic drugs, hypertonic saline and mannitol have an indication in some patients. With regard to antibiotics, dry-powder tobramycin and colistine can be substituted for the same drug delivered by nebulization. Nebulized aztreonam needs more studies to determine its place. These new treatments represent a definite advance for cystic fibrosis patients and need to be known by all practitioners. Their position in our therapeutic arsenal remains to be accurately defined.

Non-invasive airway health assessment: synchrotron imaging reveals effects of rehydrating treatments on mucociliary transit in-vivo.

To determine the efficacy of potential cystic fibrosis (CF) therapies we have developed a novel mucociliary transit (MCT) measurement that uses synchrotron phase contrast X-ray imaging (PCXI) to non-invasively measure the transit rate of individual micron-sized particles deposited into the airways of live mice. The aim of this study was to image changes in MCT produced by a rehydrating treatment based on hypertonic saline (HS), a current CF clinical treatment. Live mice received HS containing a long acting epithelial sodium channel blocker (P308); isotonic saline; or no treatment, using a nebuliser integrated within a small-animal ventilator circuit. Marker particle motion was tracked for 20 minutes using PCXI. There were statistically significant increases in MCT in the isotonic and HS-P308 groups. The ability to quantify in vivo changes in MCT may have utility in pre-clinical research studies designed to bring new genetic and pharmaceutical treatments for respiratory diseases into clinical trials.

Nebuliser systems for drug delivery in cystic fibrosis.

BACKGROUND: Nebuliser systems are used to deliver medications to control the symptoms and the progression of lung disease in people with cystic fibrosis. Many types of nebuliser systems are available for use with various medications; however, there has been no previous systematic review which has evaluated these systems. OBJECTIVES: To evaluate effectiveness, safety, burden of treatment and adherence to nebulised therapy using different nebuliser systems for people with cystic fibrosis. SEARCH METHODS: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches, handsearching of relevant journals and abstract books of conference proceedings. We searched the reference lists of each study for additional publications and approached the manufacturers of both nebuliser systems and nebulised medications for published and unpublished data. Date of the most recent search: 15 Oct 2012. SELECTION CRITERIA: Randomised controlled trials or quasi-randomised controlled trials comparing nebuliser systems including conventional nebulisers, vibrating mesh technology systems, adaptive aerosol delivery systems and ultrasonic nebuliser systems. DATA COLLECTION AND ANALYSIS: Two authors independently assessed studies for inclusion. They also independently extracted data and assessed the risk of bias. A third author assessed studies where agreement could not be reached. MAIN RESULTS: The search identified 40 studies with 20 of these (1936 participants) included in the review. These studies compared the delivery of tobramycin, colistin, dornase alfa, hypertonic sodium chloride and other solutions through the different nebuliser systems. This review demonstrates variability in the delivery of medication depending on the nebuliser system used. Conventional nebuliser systems providing higher flows, higher respirable fractions and smaller particles decrease treatment time, increase deposition and may be preferred by people with CF, as compared to conventional nebuliser systems providing lower flows, lower respirable fractions and larger particles. Nebulisers using adaptive aerosol delivery or vibrating mesh technology reduce treatment time to a far greater extent. Deposition (as a percentage of priming dose) is greater than conventional with adaptive aerosol delivery. Vibrating mesh technology systems may give greater deposition than conventional when measuring sputum levels, but lower deposition when measuring serum levels or using gamma scintigraphy. The available data indicate that these newer systems are safe when used with an appropriate priming dose, which may be different to the priming dose used for conventional systems. There is an indication that adherence is maintained or improved with systems which use these newer technologies, but also that some nebuliser systems using vibrating mesh technology may be subject to increased failures. AUTHORS' CONCLUSIONS: Clinicians should be aware of the variability in the performance of different nebuliser systems. Technologies such as adaptive aerosol delivery and vibrating mesh technology have advantages over conventional systems in terms of treatment time, deposition as a percentage of priming dose, patient preference and adherence. There is a need for long-term randomised controlled trials of these technologies to determine patient-focused outcomes (such as quality of life and burden of care), safe and effective dosing levels of medications and clinical outcomes (such as hospitalisations and need for antibiotics) and an economic evaluation of their use.

Assessment of effectiveness of percutaneous adhesiolysis in managing chronic low back pain secondary to lumbar central spinal canal stenosis.

BACKGROUND: Chronic persistent low back and lower extremity pain secondary to central spinal stenosis is common and disabling. Lumbar surgical interventions with decompression or fusion are most commonly performed to manage severe spinal stenosis. However, epidural injections are also frequently performed in managing central spinal stenosis. After failure of epidural steroid injections, the next sequential step is percutaneous adhesiolysis and hypertonic saline neurolysis with a targeted delivery. The literature on the effectiveness of percutaneous adhesiolysis in managing central spinal stenosis after failure of epidural injections has not been widely studied. STUDY DESIGN: A prospective evaluation. SETTING: An interventional pain management practice, a specialty referral center, a private practice setting in the United States. OBJECTIVE: To evaluate the effectiveness of percutaneous epidural adhesiolysis in patients with chronic low back and lower extremity pain with lumbar central spinal stenosis. METHODS: Seventy patients were recruited. The initial phase of the study was randomized, double-blind with a comparison of percutaneous adhesiolysis with caudal epidural injections. The 25 patients from the adhesiolysis group continued with follow-up, along with 45 additional patients, leading to a total of 70 patients. All patients received percutaneous adhesiolysis and appropriate placement of the Racz catheter, followed by an injection of 5 mL of 2% preservative-free lidocaine with subsequent monitoring in the recovery room. In the recovery room, each patient also received 6 mL of 10% hypertonic sodium chloride solution, and 6 mg of non-particulate betamethasone, followed by an injection of 1 mL of sodium chloride solution and removal of the catheter. OUTCOMES ASSESSMENT: Multiple outcome measures were utilized including the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake with assessment at 3, 6, and 12, 18 and 24 months post treatment. The primary outcome measure was 50% or more improvement in pain scores and ODI scores. RESULTS: Overall, a primary outcome or significant pain relief and functional status improvement of 50% or more was seen in 71% of patients at the end of 2 years. The overall number of procedures over a period of 2 years were 5.7 ± 2.73. LIMITATIONS: The lack of a control group and a prospective design. CONCLUSIONS: Significant relief and functional status improvement as seen in 71% of the 70 patients with percutaneous adhesiolysis utilizing local anesthetic steroids and hypertonic sodium chloride solution may be an effective management strategy in patients with chronic function limiting low back and lower extremity pain with central spinal stenosis after failure of conservatie management and fluoroscopically directed epidural injections.

The utility of sputum eosinophils and exhaled nitric oxide for monitoring asthma control with special attention to childhood asthma.

The monitoring of sputum eosinophils has received certain attention as a tool for improving asthma management both in children and in adults. The present paper reviews the technique and also the usefulness of induced sputum in the diagnosis and assessment of asthma, together with its ability to predict the response to treatment and to anticipate asthma exacerbations. Special attention is addressed to childhood asthma. The authors conclude that due to cost-effectiveness reasons derived from high labour costs, together with the unpleasantness of the technique and the failure to obtain adequate samples in a non-negligible percentage of children, this technique should be only used for research purposes.

Patients presenting with severe hypotonic hyponatremia: etiological factors, assessment, and outcomes.

BACKGROUND: Although hospital-acquired hyponatremia is well described, severe community-acquired hyponatremia has been studied less extensively. AIM: To assess characteristics and outcomes of patients admitted with severe hypotonic hyponatremia (SHH) (defined as serum sodium ≤ 120 mmol/L). METHODS: All patients with serum sodium of ≤ 120 mmol/L who were admitted to 2 large teaching hospitals from January 2000 to August 2007 were identified, and data were obtained from medical records. Main outcome measures were incidence of osmotic demyelination and mortality. RESULTS: Two hundred fifty-five patients were admitted who had SHH (female to male ratio 2:1), and the mean age was 72 ± 14 years. The most common etiological factors were thiazide/indapamide diuretics (41%), syndrome of inappropriate antidiuretic hormone secretion (38%), and hypovolemia (24%). Inappropriately rapid correction of serum sodium (> 12 mmol/L over the first 24 hours) occurred in 37 patients (15%), with 4 patients (11%) developing osmotic demyelination. Patients who developed osmotic demyelination were more likely to be younger, abuse alcohol (3 of 4 patients), and have lower serum potassium levels. One patient had a hypoxic-anoxic episode at presentation. The patients also had a mean serum sodium increase in the first 24 and 48 hours of 21 ± 5 mmol/L and 28 ± 8 mmol/L, respectively. None of the patients with osmotic demyelination received hypertonic saline. None of the patients in whom the serum sodium increment was limited to ≤ 12 mmol/L developed osmotic demyelination. Overall, mortality was 10% and was not related to sodium level at presentation. CONCLUSIONS: Patients treated with thiazide or indapamide (particularly elderly women) may benefit from monitoring of serum sodium levels. Inappropriately rapid serum sodium correction is associated with osmotic demyelination, particularly in patients with risk factors for this condition. In contrast to what has been reported for hyponatremia in hospitalized patients, severity of hyponatremia on admission did not predict increased mortality in our patient population.

Assessment of urodynamic bladder behavior on filling with solutions representing physiological extremes of urinary osmolarity

OBJECTIVE: Verify if there is any difference in sensitive and motor bladder response in the presence of solutions with different osmolarities, simulating physiological extremes of urinary osmolarity. MATERIALS AND METHODS: Thirty-three patients (24 men and 9 women) with mean age of 46.4 years (8 to 87 years) took part in this study. They were all subjected to 2 consecutive urodynamic examinations. In each exam, the vesical filling was accomplished by using a hyperosmolar (1000 mOsm/L) or hypo-osmolar (100 mOsm/L) sodium chloride solution in similar speed. The sequence in which each solution was instilled was determined by a double blind draw. The urodynamic results obtained from the infusion of both solutions were compared, regardless the sequence of administration. RESULTS: Fifteen patients (45.4 percent) showed detrusor hyperactivity, 12 of whom with neurological antecedents. The mean age of those with detrusor hyperactivity was 45.8 years, against 46.9 for those without hyperactivity. The infusion of the hyperosmolar/hypo-osmolar solution generated the following results, when comparing patients without vs. with detrusor hyperactivity: initial sensation of vesical filling (mL): 167.5 / 159.2 vs. 134.9 / 157.3 (p > 0.05); volume of occurrence of the first involuntary bladder contraction (mL): 163.9 / 151.9 (p > 0.05); detrusor micturition pressure (cm H2O): 24.0 / 24.4 vs. 13.8 / 27.5 (p > 0.05). CONCLUSION: The vesical filling with solutions simulating extreme urinary osmolarities, accomplished with similar speed and without previous identification, did not likewise alter the sensitive and motor urodynamic behavior in the current study.

Assessment of urodynamic bladder behavior on filling with solutions representing physiological extremes of urinary osmolarity.

OBJECTIVE: Verify if there is any difference in sensitive and motor bladder response in the presence of solutions with different osmolarities, simulating physiological extremes of urinary osmolarity. MATERIALS AND METHODS: Thirty-three patients (24 men and 9 women) with mean age of 46.4 years (8 to 87 years) took part in this study. They were all subjected to 2 consecutive urodynamic examinations. In each exam, the vesical filling was accomplished by using a hyperosmolar (1000 mOsm/L) or hypo-osmolar (100 mOsm/L) sodium chloride solution in similar speed. The sequence in which each solution was instilled was determined by a double blind draw. The urodynamic results obtained from the infusion of both solutions were compared, regardless the sequence of administration. RESULTS: Fifteen patients (45.4%) showed detrusor hyperactivity, 12 of whom with neurological antecedents. The mean age of those with detrusor hyperactivity was 45.8 years, against 46.9 for those without hyperactivity. The infusion of the hyperosmolar/hypo-osmolar solution generated the following results, when comparing patients without vs. with detrusor hyperactivity: initial sensation of vesical filling (mL): 167.5/159.2 vs. 134.9/157.3 (p > 0.05); volume of occurrence of the first involuntary bladder contraction (mL): 163.9/151.9 (p > 0.05); detrusor micturition pressure (cm H2O): 24.0/24.4 vs. 13.8/27.5 (p > 0.05). CONCLUSION: The vesical filling with solutions simulating extreme urinary osmolarities, accomplished with similar speed and without previous identification, did not likewise alter the sensitive and motor urodynamic behavior in the current study.

Comparison of intravenous and pulmonary artery injections of hypertonic saline for the assessment of conductance catheter parallel conductance.

OBJECTIVE: The conductance catheter provides a continuous measure of left ventricular volume. Conversion of raw data to calibrated absolute volume requires assessment of parallel conductance. Conventionally, parallel conductance is determined by injecting a small bolus hypertonic saline into the pulmonary artery and analyzing the signal obtained during passage of the bolus through the left ventricle. However, in some cases, a pulmonary artery catheter is not practicable. Therefore, we investigated whether intravenous hypertonic saline injections yield reliable parallel conductance estimates. METHODS: In 13 anesthetized sheep (33+/-5 kg) parallel conductance was obtained by pulmonary artery and by intravenous injections. Measurements (triplicate) were done at baseline, during dobutamine and pacing, and repeated after embolization of the right coronary artery in order to assess the effects of enlarged right ventricular volumes. We used a multiple linear regression model to determine the relation between parallel conductance obtained by the two methods and to quantify the effects of dobutamine, pacing, and embolization. RESULTS: The two methods show an excellent correlation with a systematic overestimation for intravenous injection. The mean parallel conductance obtained by pulmonary artery injection was 0.690+/-0.009 ohm(-1) whereas intravenous injection yielded 0.739+/-0.015 ohm(-1). Interanimal variability was 0.138 ohm(-1). The difference between the two methods was relatively small, but highly significant (+0.049+/-0.012 ohm(-1), P<0.001). Embolization resulted in significantly higher values (+0.141+/-0.017 ohm(-1), P<0.001), but dobutamine and pacing did not significantly affect parallel conductance (+0.021+/-0.016 ohm(-1), NS). There was no interaction between these interventions and the injection method, indicating that the relation between parallel conductances obtained by the two methods was maintained in all conditions. CONCLUSION: Parallel conductance obtained by intravenous injection was significantly higher (+7%) than by pulmonary artery injection. However, the relation between the two methods is highly linear with an excellent correlation and is not affected by large hemodynamic changes. The systematic difference between the two methods is likely due to increased conductivity of blood in the right ventricle which is present with intravenous injection but not with pulmonary artery injection. Determination of parallel conductance by intravenous injection is a good alternative for conventional pulmonary artery injection and may be applied in studies where pulmonary artery injection is problematic. This may include studies in very small animals or studies in patients prone to arrhythmias or with cardiac anomalies such as pulmonary artery stenosis. In addition, intravenous injection could be used in biventricular studies to obtain right and left ventricular parallel conductances from a single saline injection.

Comparison of sputum induction with fiber-optic bronchoscopy in the diagnosis of tuberculosis.

Microbiologic confirmation of pulmonary tuberculosis among patients whose sputum smear is negative is increasingly important because of greater incidence among immunocompromised hosts and emergence of drug-resistant strains. We prospectively compared sputum induction to fiber-optic bronchoscopy in the diagnosis of such patients. Consecutive patients referred for investigation of possible active pulmonary tuberculosis underwent sputum induction with hypertonic saline delivered by an ultrasonic nebulizer between 2 and 48 h before transnasal fiber-optic bronchoscopy. All specimens were examined for acid-fast bacilli with fluorescent microscopy and cultured for mycobacteria. Clinical information was abstracted from patient records, and X-rays were reviewed by two blinded readers. Among 101 participants, sputum induction was well-tolerated without complications and provided adequate samples in 93. Sensitivity of direct acid-fast bacilli smear of specimens from both techniques was low. Sensitivity and negative predictive value of culture from bronchoscopy specimens was 73% and 91% compared with 87% and 96%, respectively, for sputum induction when a specimen was obtained. Direct costs for bronchoscopy totaled Canadian $187.60 compared with Canadian $22.22 for sputum induction. Sputum induction was well-tolerated, low-cost, and provided the same, if not better, diagnostic yield compared with bronchoscopy in the diagnosis of smear-negative pulmonary tuberculosis.