Alfapump® system vs. large volume paracentesis for refractory ascites: A multicenter randomized controlled study.

BACKGROUND AND AIMS: Patients with refractory ascites (RA) require repeated large volume paracenteses (LVP), which involves frequent hospital visits and is associated with a poor quality-of-life. This study assessed safety and efficacy of an automated, low-flow pump (alfapump® [AP]) compared with LVP standard of care [SoC]. METHODS: A randomized controlled trial, in seven centers, with six month patient observation was conducted. Primary outcome was time to first LVP. Secondary outcomes included paracentesis requirement, safety, health-related quality-of-life (HRQoL), and survival. Nutrition, hemodynamics, and renal injury biomarkers were assessed in a sub-study at three months. RESULTS: Sixty patients were randomized and 58 were analyzed (27 AP, 31 SoC, mean age 61.9years, mean MELD 11.7). Eighteen patients were included in the sub-study. Compared with SoC, median time to first LVP was not reached after six months in the AP group, meaning a significant reduction in LVP requirement for the AP patients (AP, median not reached; SoC, 15.0days (HR 0.13; 95%CI 13.0-22.0; p<0.001), and AP patients also showed significantly improved Chronic Liver Disease Questionnaire (CLDQ) scores compared with SoC patients (p<0.05 between treatment arms). Improvements in nutritional parameters were observed for hand-grip strength (p=0.044) and body mass index (p<0.001) in the sub-study. Compared with SoC, more AP patients reported adverse events (AEs; 96.3% vs. 77.4%, p=0.057) and serious AEs (85.2 vs. 45.2%, p=0.002). AEs consisted predominantly of acute kidney injury in the immediate post-operative period, and re-intervention for pump related issues, and were treatable in most cases. Survival was similar in AP and SoC. CONCLUSIONS: The AP system is effective for reducing the need for paracentesis and improving quality of life in cirrhotic patients with RA. Although the frequency of SAEs (and by inference hospitalizations) was significantly higher in the AP group, they were generally limited and did not impact survival. Lay summary: The alfapump® moves abdominal fluid into the bladder from where it is then removed by urination. Compared with standard treatment, the alfapump reduces the need for large volume paracentesis (manual fluid removal by needle) in patients with medically untreatable ascites. This can improve life quality for these patients. www.clinicaltrials.gov#NCT01528410.

[Medical and psychological aspects of the treatment of connatal dacryostenosis : Parental evaluation of their own and their child's stress]. / Medizinpsychologische Aspekte bei der Behandlung kindlicher Tränenabflussstörungen : Elterliche Beurteilung eigenen und kindlichen Stresserlebens.

BACKGROUND: Lacrimal probing and syringing for connatal dacryostenosis can be performed under local (LA) and general anesthesia (GA). In cases of invasive medical procedures, pain and anxiety can be distressing for children and their parents. MATERIALS AND METHODS: Using questionnaires (n = 65), parents were asked to evaluate their own stress and that of their child during lacrimal probing and syringing. Analyzing different subgroups, the impact of the kind of anesthesia (LA vs. GA), trust in medical treatment, therapeutic success, prior experiences with GA, parental educational level, age of parents and children, number of children, and time between the intervention and the interview on the stress was examined. Stress level was evaluated on a scale from 1 (no stress) to 10 (maximal stress). RESULTS: Mean children's age was 8.5 ± 7.42 months. Mean age of the parents was 30.8 ± 6.17 years. Treating children under LA, parents reported moderate to severe stress levels for themselves (mean, M = 7.15) and for their children (M = 7.82). Children's stress levels were significantly higher when the treatment was performed under LA (n = 47; M = 7.34) in comparison to GA (n = 18; M = 6.06; p < 0.05). Parents having two or more children reported significantly lower stress levels than those with only one child. Furthermore, prior experiences with GA led to significantly higher parental stress levels when their children were treated under GA. Other factors did not show any impact on parent's and children's stress levels. CONCLUSIONS: Parents might have been influenced by hearing the children's reaction (e. g., crying) during the intervention under LA. Nevertheless, parents had a higher acceptance of this type of intervention (LA) in comparison to GA. This effect was even stronger among parents with prior experience of GA.

Nasopharyngeal suctioning does not produce a salivary cortisol reaction in preterm infants.

AIM: To investigate whether nasopharyngeal suctioning produces a physiological and behavioural stress reaction in preterm infants and if a possible reaction can be dampened by sweet solution. METHODS: Eleven preterm infants were randomly assigned to receive either 30% oral glucose or nothing prior to morning nasopharyngeal suctioning; the procedure was reversed in the afternoon. The study included a total of 44 samples from preterm infants evaluated with salivary cortisol, pain score (Visual Analogue Scale), heart rate, oxygen saturation and recovery time through the Newborn Individualized Developmental Care and Assessment Program. For reference, 44 samples from eleven full-term infants were evaluated for salivary cortisol. RESULTS: Regardless of whether or not preterm infants received glucose before nasopharyngeal suctioning, no statistically significant difference was found in salivary cortisol reactivity, pain score, heart rate, oxygen saturation or recovery time. Nor were any statistically significant differences between salivary cortisol baseline and response values found in full-term infants after nasopharyngeal suctioning. CONCLUSION: In the present setting, nasopharyngeal suctioning was not stressful enough to increase salivary cortisol or pain score. Oral glucose did not alter salivary cortisol levels.

Confirming the factor structure of modified CFSS-DS in Finnish children at different ages.

OBJECTIVE: The aims were to determine whether means of different fear-related items were similar in 1998 and 2001 and to find a common factor structure of the modified CFSS-DS for children at different ages. MATERIALS AND METHODS: Independent random samples of 6-, 9-, 12- and 15-year olds were drawn in two cities in 1998 and 2001 (n = 180 per age group from each city). The study group in 2001 comprised 282, 265, 281 and 234 subjects aged 6, 9, 12 and 15 years, respectively. Each child received a modified CFSS-DS form to be filled out at home. Mean scores of different fear-related items were reported for each age group for both data sets. Confirmatory factor analyses (CFA) were performed to test whether the three factor structures revealed for 6-, 9- and 12-15-year olds in 1998 fitted the 2001 data. Multiple group CFA was used to test for the equivalence of the factorial structure across age groups (configural invariance). RESULTS: The age-specific patterns of the means for individual fear-related items in 2001 corresponded to the mean values for 1998. When age-specific factor structures were tested separately for each age group, the factor structure for 9-year-olds was, in general, the best-fitting overall structure. The factor structure had a good fit for all age groups, but the loadings differed at different ages. CONCLUSIONS: The modified CFSS-DS provides consistent factor structures for children at different ages and reflects the changes in manifestations of dental fear during growth.

Evaluation of an educational intervention to promote breast pump use among women with infants in a special care nursery in Kenya.

OBJECTIVES: Development of an educational program for women of special care nursery (SCN) infants in Kenya about the use and cleaning of breast pumps through culturally appropriate teaching tools as well as conduction of an evaluation of change in knowledge, attitudes, beliefs, and practical ability in pump use following the educational intervention. DESIGN: An evaluation of an educational intervention. SAMPLE: 40 women with infants in the SCN unable to directly breastfeed. INTERVENTION: Educational intervention instructing electric or pedal breast pump use and cleaning with a pre- and posttest evaluation. RESULTS: Paired t test scores of the combined practically oriented questions were significantly increased from 1.8 to 4.6 (p<.001) from pre- to posttest scores. Likewise, the practical demonstration of learned pump use skills significantly improved from 0.08 preintervention to 4.8 postintervention ( p<.001). CONCLUSIONS: Results of the evaluation indicated the intervention significantly increased women's practical knowledge regarding use and cleaning of the breast pump and accessories. With knowledge of proper use of breast pumps, women will be more likely to successfully utilize pumps to provide adequate milk volumes for SCN infants. A culturally appropriate educational intervention in developing countries appears to be a feasible means of facilitating instruction of breast pump use.

Relief of Procedural Pain in Critically Ill Patients by Music Therapy: A Randomized Controlled Trial.

BACKGROUND: This study aimed to determine the effectiveness of music listening for procedural pain relief using two different observational pain tools during endotracheal suctioning. MATERIALS AND METHODS: This study was a randomized controlled trial. The sample of the study included 98 patients with mechanical ventilation support who met the selection criteria. The patients were randomly assigned to control and music therapy groups. Patients in the control group were routinely suctioned as usual. Patients in the music group received music therapy 20 min before, during, and 20 min after endotracheal suctioning. The primary outcome was the pain relief during suctioning. RESULTS: Forty patients in each arm completed the study. Pain scores in the Critical Care Pain Observation Tool and Behavioral Pain Scale were lower in the music group than in the control group during endotracheal suctioning (group: F = 14.85, p = 0.000; F = 9.04, p = 0.000, respectively). It was also found to be a significant interaction effect between the groups and time (group × time: F = 17.35, p = 0.000; F = 18.00, p = 0.000, respectively). CONCLUSION: The Critical Care Pain Observation Tool and Behavioral Pain Scale in the current study generally demonstrated similar pain scores during the painful procedure. Our findings support that music therapy may act as a nonpharmacological therapy to relieve procedural pain in patients on mechanical ventilation.

Efficacy of TNP on lower limb wounds: a meta-analysis.

This meta-analysis of the three RCTs that have compared topical negative pressure with conventional treatment in patients with lower limb ulcers found that it significantly reduced healing times and increased the number of healed wounds.

A pilot study on the effect of topical negative pressure on quality of life.

OBJECTIVE: To discover the impact of topical negative pressure (TNP) on quality of life. METHOD: An exploratory prospective cohort study was conducted on 26 patients undergoing TNP. The Cardiff Wound Impact Schedule (CWIS), a wound-specific tool, was used to investigate quality-of-life scores before therapy and four weeks after therapy or at wound closure. Wound dimensions were measured at both assessments, and the values for the CWIS domains (physical symptoms, social functioning, well-being and overall quality of life) were investigated using parametric and non-parametric tests. RESULTS: The mean duration of TNP therapy was 3.3 +/- 1.7 weeks. Topical negative pressure therapy helped to achieve complete wound closure in 14 patients (54%), and there was a mean reduction in wound surface area from 52.2 cm2 (range 4-150) to 26.8 cm2 (0-120). While there was no significant change in quality of life in patients whose wounds healed (1 +/- 11.9), the physical-functioning domain improved in obese patients (20 +/- 21, p < 0.05) and worsened in ambulatory patients (-3 +/- 13, p < 0.05). The portableTNP system had no significant impact on quality of life (-3 +/- 16), while the global quality-of-life score worsened with surgical intervention (-0.5 +/- 2, p < 0.05). CONCLUSION: Although TNP aids wound closure in patients with complex wounds, in selected cases their quality of life can worsen. This is the first exploratory cohort study of its kind, and has identified an urgent need to validate the use of patient-based outcome measures in TNP therapy. Such data can be useful in allocating resources and justifying funding in wound care.

Diagnostic accuracy and distress associated with oropharyngeal suction in cystic fibrosis.

BACKGROUND: Early detection of bacterial pathogens in the lower airway is an important part of managing CF. This study aimed to assess the diagnostic accuracy of oropharyngeal suction (OPS) samples in obtaining airway bacterial cultures in young children with cystic fibrosis (CF), and the level of child distress caused by obtaining OPS samples. METHODS: Young children with CF undergoing broncho-alveolar lavage (BAL) as part of concurrent research or routine annual surveillance were studied. OPS was performed by stimulating a cough and suctioning the back of the oropharynx in the awake child to replicate clinical practice. BAL of the right upper, middle and lingula lobes was then performed. Samples were sent for standard bacterial culture. The child's distress during OPS was rated using the Groningen Distress Scale (1=calm, 2=timid/nervous, 3=serious distress but still under control, 4=serious distress with loss of control, 5=panic). RESULTS: There were 65 paired samples obtained from 39 children (21 boys, mean age on day of first sampling was 34.1months, SD 19.1months). For Pseudomonas aeruginosa, specificity, sensitivity, NPV and PPV with 95% CI were 98% (87-99), 75% (20-96), 98% (91-98) and 60% (15-93%) respectively. In all age groups combined, median level of distress was 3 (IQR 2-4), with distress highest in 2 and 3year olds, with a median of 4 (IQR 3-4). CONCLUSION: OPS has diagnostic utility in determining the absence of organisms in the lower airway, with specificity for P.aeruginosa detection of 98%. However, a positive OPS result is not necessarily a good indicator of lower airway infection. Distress levels were high during OPS, mostly in 2 and 3year olds.

Patient preference for in-exsufflation for secretion management with spinal cord injury.

An important aspect of respiratory management in patients with acute spinal cord injury (SCI) is the elimination of secretions. Methods utilized for secretion management in patients with SCI includes endotracheal suctioning and mechanical in-exsufflation (MI-E). Surveyed here is a group of patients with SCI who have had experience with both endotracheal suctioning and MI-E via tracheostomy, to determine patient opinions and experiences regarding the 2 techniques. The survey was administered to 18 patients with traumatic SCI, with an average age of 34. 72% were ASIA A, 22% percent were ASIA B, and 6% were ASIA C, with neurological level of injury ranging from C-1-T-3. Results indicate that patients found MI-E significantly less irritating (p < 0.001), less painful (p < 0.001), less tiring (p = 0.01), and less uncomfortable (p < 0.001) than endotracheal suctioning. In a direct comparison, 89% of patients preferred mechanical in-exsufflation to suctioning. In addition, 89% of patients found MI-E faster, 78% found MI-E more convenient, and 72% found MI-E more effective than suctioning. This study demonstrates that all measured aspects of patient experience are more positive for MI-E than for endotracheal suctioning.

The active urine collection device: a novel continence management system focusing particularly on the needs of disabled women.

PURPOSE: This paper introduces a novel incontinence management system which applies space technology to the problem of urinary incontinence. The purpose of this paper is to invite comments and suggestions from professionals in the disability and rehabilitation field. METHOD: Severe urinary incontinence is a distressing condition for which there are few satisfactory management solutions. We have been able to develop a compact liquid handling system that can cope with the initial surge of urine which characteristically reaches a high flow rate of around 25 ml/sec. By using a sophisticated system of filters, the device can cope with mixed streams of urine and air which are inevitable when a non-invasive patient/device interface is used. The next phase of the project is to develop prototype devices with the aid of users to produce an effective appliance that users and carers find practical and acceptable to use. CONCLUSION: With the aid of users, carers and rehabilitation experts we hope to develop an excellent user-friendly product. We believe this device can make a positive contribution to the quality of life of disabled people with continence difficulties.

Duration of breast milk expression among working mothers enrolled in an employer-sponsored lactation program.

BACKGROUND: Maternal employment has been one of the greatest barriers to breastfeeding. Women are increasingly solving this problem by expressing milk at work and taking it home to their infants. PURPOSE: The objective was to determine duration of breast milk expression among working mothers enrolled in an employer-sponsored lactation program. DESIGN AND METHODS: Retrospective reviews were conducted on the lactation records of 462 women employed by 5 corporations in order to describe and characterize their experiences. The lactation program included the employees' choice of (a) a class on the benefits of breastfeeding; (b) services of a certified lactation consultant (CLC); and (c) private room in the workplace with equipment for pumping. RESULTS: Breastfeeding was initiated by 97.5% of the participants, with 57.8% continuing for at least 6 months. Of the 435 (94.2%) who returned to work after giving birth, 343 (78.9%) attempted pumping milk at work, and 336 (98%) were successful. They expressed milk in the workplace for a mean of 6.3 months (SD = 3.9, range 2 weeks to 21 months). The mean age of infants when the mothers stopped pumping at work was 9.1 months (SD = 4.1, range 1.9 to 25 months). Most of the women who pumped their milk at work were working full time (84.2%). The mean postnatal maternity leave was 2.8 months. The proportion of women who chose to pump at work was higher among women who were salaried than among those who were paid hourly wages (p < 0.01). CONCLUSIONS: Company-sponsored lactation programs can enable employed mothers to provide breast milk for their infants as long as they wish, thus helping the nation attain the Healthy People 2010 goals of 50% of mothers breastfeeding until their infants are 6-months-old.

The effect of facilitated tucking position during endotracheal suctioning on physiological responses and coping with stress in premature infants: a randomized controlled crossover study.

OBJECTIVE: Premature infants respond more intensively to pain compared with term infants. Facilitated tucking position as a non-pharmacological method of pain in infants has been suggested; however, its effect on acute procedural pain such as endotracheal suctioning remains to be studied. This study examined the effect of facilitated tucking position during suctioning on physiological responses and coping with stress in premature infants. METHODS: This was a randomized controlled crossover study. Thirty-four premature infants received an order of either suctioning with intervention - suctioning without intervention, or suctioning without intervention - suctioning with intervention. Neonatal Infant Pain Scale (NIPS) was used to collect the data. RESULTS: No statistical significant difference was seen between intervention and non-intervention cases in terms of the average time duration to reach the pain score to one or zero, and also, in the average of changes in oxygen saturation. However, changes in heart rate were less in intervention cases. CONCLUSION: The effect of facilitated tucking position on coping with stress was not found in this study. This non-pharmacological strategy can be suggested because of its effect on reducing changes in heart rate during painful procedure. It is suggested to replicate the study with larger number of samples.

Audiovisual distraction reduces pain perception during aural microsuction.

INTRODUCTION: Aural microsuction is a common ear, nose and throat procedure used in the outpatient setting. Some patients, however, find it difficult to tolerate owing to discomfort, pain or noise. This study evaluated the effect of audiovisual distraction on patients' pain perception and overall satisfaction. METHODS: A prospective study was conducted for patients attending our aural care clinic requiring aural toileting of bilateral mastoid cavities over a three-month period. All microsuction was performed by a single clinical nurse specialist. Any patients with active infection were excluded. For each patient, during microsuction of one ear, they watched the procedure on a television screen while for the other ear they did not view the procedure. All patients received the same real time explanations during microsuction of both ears. After the procedure, each patient completed a visual analogue scale (VAS) to rate the pain they experienced for each ear, with and without access to the television screen. They also documented their preference and reasons why. RESULTS: A total of 37 patients were included in the study. The mean pain score for patients viewing the procedure was 2.43 compared with a mean of 3.48 for patients with no television view. This difference in patients' pain perception was statistically lower in the group who observed the procedure on the television (p=0.003), consistent with the majority of patients reporting a preference to viewing their procedure (65%). CONCLUSIONS: Audiovisual distraction significantly lowered patients' VAS pain scores during aural microsuction. This simple intervention can therefore reduce patients' perceived pain and help improve acceptance of this procedure.

Assessing sedation in a pediatric intensive care unit using Comfort Behavioural Scale and Bispectral Index: these tools are different.

BACKGROUND: The aim of this paper was to monitor comfort in pediatric critical ill patients which is necessary to adequate analgesic and sedative therapy. The primary objective of this prospective observational study was to measure the level of sedation in a Pediatric Intensive Care Unit (PICU) of a tertiary care Hospital, using Comfort Behavioural Scale (CBS) and Bispectral Index (BIS), evaluating the agreement between these tools; secondly we analyzed the correlation of an adequate level of sedation and patient's outcome. METHODS: We enrolled 46 patients, mechanically ventilated for almost 12 hours, monitored at a basal level and during a stimulus (tracheal suctioning). As outcome variables we analyzed: length of ventilation and PICU stay, duration of sedative therapy and weaning, time between beginning of sedative administration and start of weaning, presence of infection. RESULTS: Twenty-six percent (doctor CBS score), 34.8% (nurse CBS score) and 73.9% (BIS) of our population were found adequately sedated; none state of undersedation was reported. During the stimulus the percentage of adequately sedated patients according to CBS became 78.2%. CBS level of agreement versus BIS was weak. No significative difference was found between doctor and nurse CBS score. Length of PICU stay and duration of sedative administered were significant shorter in patients adequately sedated at Bispectral Index monitoring; no outcome variable resulted significant looking at CBS score. CONCLUSION: Our data support the risk of oversedation in critically ill patients and the difference between CBS and BIS, especially in evaluating light oversedation state. The presence of an excessive level of sedation evaluated by BIS was associated with duration of hospitalization and sedative administration.

Birth to breast--a feeding care map for the NICU: helping the extremely low birth weight infant navigate the course.

Breast milk has been shown to contribute significantly to positive neurodevelopmental and medical outcomes in the extremely low birth weight (ELBW) infant population. It is crucial that ELBW infants receive their mother's colostrum as a first feeding, followed by expressed breast milk for as long as possible. Evidence-based literature supports the difficult challenges both mothers and ELBW infants face if they are to succeed at breast pumping and breastfeeding. Influencing factors include the medical fragility of the infant, limited frequency and duration of kangaroo care between mother and infant, lack of an adequate volume of breast milk, as well as inconsistent or incorrect information surrounding the use of breast milk and breastfeeding. A feeding care map as described in this article can help the bedside nurse assist the mother-ELBW infant dyad in optimizing breast milk volumes, laying the groundwork for breastfeeding. Displaying supportive practices and preterm infant developmental milestones, the map categorizes infant, maternal, and dyad feeding issues along a progressive time line from admission to discharge.

Dental fear of Finnish children in the light of different measures of dental fear.

OBJECTIVES: The aims were: (1) to examine the construct and reliability of the modified Dental Subscale of the Children's Fear Survey Schedule (CFSS-DS) among children of different ages and (2) to compare the correlations between fear measured with the modified CFSS-DS, the "peak value for dental fear" (PV), and "fear of dental treatment in general" (GF). METHODS: The study sample consisted of 302, 299, 314, and 297 children aged 6, 9, 12, and 15 years, respectively. Each child received a questionnaire to be filled out at home. An explorative factor analysis with varimax rotation was performed for eight items taken from the CFSS-DS and questions on fear of pain and suction used in the mouth. For further age-specific analyses, mean values were calculated for the sum of items that loaded >0.5 on each factor. The correlations between these values and PV and GF were studied. RESULTS: The questionnaire was reliable. Two factors were revealed for each age: "treatment of dental decay" (TDD), which included fears related to invasive treatment, and "attending the dentist" (AD), which included fears related to dental visits in general. TDD explained over 50% of the variance, except among 9-year-olds. TDD mean values were higher among older children than among younger ones and correlated more strongly with PV than with GF. AD mean values were higher among younger children than among older ones and correlated more strongly with GF than with PV. CONCLUSION: The factor structures were fairly similar but the correlations between fear measures differed among children of different ages.