scholarly journals Prospective multicentre randomised, double-blind, equivalence study comparing clonidine and midazolam as intravenous sedative agents in critically ill children: the SLEEPS (Safety profiLe, Efficacy and Equivalence in Paediatric intensive care Sedation) study

2014 ◽  
Vol 18 (71) ◽  
pp. 1-212 ◽  
Author(s):  
Andrew Wolf ◽  
Andrew McKay ◽  
Catherine Spowart ◽  
Heather Granville ◽  
Angela Boland ◽  
...  
Keyword(s):  
Intensive Care ◽  
Health Technology Assessment ◽  
Critically Ill ◽  
Technology Assessment ◽  
Safety Data ◽  
Health Technology ◽  
Paediatric Intensive Care ◽  
Critically Ill Children ◽  
Double Blind ◽  
Rebound Hypertension

BackgroundChildren in paediatric intensive care units (PICUs) require analgesia and sedation but both undersedation and oversedation can be harmful.ObjectiveEvaluation of intravenous (i.v.) clonidine as an alternative to i.v. midazolam.DesignMulticentre, double-blind, randomised equivalence trial.SettingTen UK PICUs.ParticipantsChildren (30 days to 15 years inclusive) weighing ≤ 50 kg, expected to require ventilation on PICU for > 12 hours.InterventionsClonidine (3 µg/kg loading then 0–3 µg/kg/hour) versus midazolam (200 µg/kg loading then 0–200 µg/kg/hour). Maintenance infusion rates adjusted according to behavioural assessment (COMFORT score). Both groups also received morphine.Main outcome measuresPrimary end point Adequate sedation defined by COMFORT score of 17–26 for ≥ 80% of the time with a ± 0.15 margin of equivalence.Secondary end points Percentage of time spent adequately sedated, increase in sedation/analgesia, recovery after sedation, side effects and safety data.ResultsThe study planned to recruit 1000 children. In total, 129 children were randomised, of whom 120 (93%) contributed data for the primary outcome. The proportion of children who were adequately sedated for ≥ 80% of the time was 21 of 61 (34.4%) – clonidine, and 18 of 59 (30.5%) – midazolam. The difference in proportions for clonidine–midazolam was 0.04 [95% confidence interval (CI) –0.13 to 0.21], and, with the 95% CI including values outside the range of equivalence (–0.15 to 0.15), equivalence was not demonstrated; however, the study was underpowered. Non-inferiority of clonidine to midazolam was established, with the only values outside the equivalence range favouring clonidine. Times to reach maximum sedation and analgesia were comparable hazard ratios: 0.99 (95% CI 0.53 to 1.82) and 1.18 (95% CI 0.49 to 2.86), respectively. Percentage time spent adequately sedated was similar [medians clonidine 73.8% vs. midazolam 72.8%: difference in medians 0.66 (95% CI –5.25 to 7.24)]. Treatment failure was 12 of 64 (18.8%) on clonidine and 7 of 61 (11.5%) on midazolam [risk ratio (RR) 1.63, 95% CI 0.69 to 3.88]. Proportions with withdrawal symptoms [28/60 (46.7%) vs. 30/58 (52.6%)] were similar (RR 0.89, 95% CI 0.62 to 1.28), but a greater proportion required clinical intervention in those receiving midazolam [11/60 (18.3%) vs. 16/58 (27.6%) (RR 0.66, 95% CI 0.34 to 1.31)]. Post treatment, one child on clonidine experienced mild rebound hypertension, not requiring intervention. A higher incidence of inotropic support during the first 12 hours was required for those on clonidine [clonidine 5/45 (11.1%) vs. midazolam 3/52 (5.8%)] (RR 1.93 95% CI 0.49 to 7.61).ConclusionsClonidine is an alternative to midazolam. Our trial-based economic evaluation suggests that clonidine is likely to be a cost-effective sedative agent in the PICU in comparison with midazolam (probability of cost-effectiveness exceeds 50%). Rebound hypertension did not appear to be a significant problem with clonidine but, owing to its effects on heart rate, specific cardiovascular attention needs to be taken during the loading and early infusion phase. Neither drug in combination with morphine provided ideal sedation, suggesting that in unparalysed patients a third background agent is necessary. The disappointing recruitment rates reflect a reluctance of parents to provide consent when established on a sedation regimen, and reluctance of clinicians to allow sedation to be studied in unstable critically ill children. Future studies will require less exacting protocols allowing enhanced recruitment.Trial registrationCurrent Controlled Trials ISRCTN02639863.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 18, No. 71. See the NIHR Journals Library website for further project information.

scholarly journals Prophylactic levofloxacin to prevent infections in newly diagnosed symptomatic myeloma: the TEAMM RCT

2019 ◽  
Vol 23 (62) ◽  
pp. 1-94 ◽  
Author(s):  
Mark T Drayson ◽  
Stella Bowcock ◽  
Tim Planche ◽  
Gulnaz Iqbal ◽  
Guy Pratt ◽  
...  
Keyword(s):  
Overall Survival ◽  
Cost Effectiveness ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Newly Diagnosed ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Febrile Episodes

Background Myeloma causes profound immunodeficiency and recurrent serious infections. There are approximately 5500 new UK cases of myeloma per annum, and one-quarter of patients will have a serious infection within 3 months of diagnosis. Newly diagnosed patients may benefit from antibiotic prophylaxis to prevent infection. However, the use of prophylaxis has not been established in myeloma and may be associated with health-care-associated infections (HCAIs), such as Clostridium difficile. There is a need to assess the benefits and cost-effectiveness of the use of antibacterial prophylaxis against any risks in a double-blind, placebo-controlled, randomised clinical trial. Objectives To assess the risks, benefits and cost-effectiveness of prophylactic levofloxacin in newly diagnosed symptomatic myeloma patients. Design Multicentre, randomised, double-blind, placebo-controlled trial. A central telephone randomisation service used a minimisation computer algorithm to allocate treatments in a 1 : 1 ratio. Setting A total of 93 NHS hospitals throughout England, Northern Ireland and Wales. Participants A total of 977 patients with newly diagnosed symptomatic myeloma. Intervention Patients were randomised to receive levofloxacin or placebo tablets for 12 weeks at the start of antimyeloma treatment. Treatment allocation was blinded and balanced by centre, estimated glomerular filtration rate and intention to give high-dose chemotherapy with autologous stem cell transplantation. Follow-up was at 4-week intervals up to 16 weeks, with a further follow-up at 1 year. Main outcome measures The primary outcome was to assess the number of febrile episodes (or deaths) in the first 12 weeks from randomisation. Secondary outcomes included number of deaths and infection-related deaths, days in hospital, carriage and invasive infections, response to antimyeloma treatment and its relation to infection, quality of life and overall survival within the first 12 weeks and beyond. Results In total, 977 patients were randomised (levofloxacin, n = 489; placebo, n = 488). A total of 134 (27%) events (febrile episodes, n = 119; deaths, n = 15) occurred in the placebo arm and 95 (19%) events (febrile episodes, n = 91; deaths, n = 4) occurred in the levofloxacin arm; the hazard ratio for time to first event (febrile episode or death) within the first 12 weeks was 0.66 (95% confidence interval 0.51 to 0.86; p = 0.002). Levofloxacin also reduced other infections (144 infections from 116 patients) compared with placebo (179 infections from 133 patients; p-trend of 0.06). There was no difference in new acquisitions of C. difficile, methicillin-resistant Staphylococcus aureus and extended-spectrum beta-lactamase Gram-negative organisms when assessed up to 16 weeks. Levofloxacin produced slightly higher quality-adjusted life-year gains over 16 weeks, but had associated higher costs for health resource use. With a median follow-up of 52 weeks, there was no significant difference in overall survival (p = 0.94). Limitations Short duration of prophylactic antibiotics and cost-effectiveness. Conclusions During the 12 weeks from new diagnosis, the addition of prophylactic levofloxacin to active myeloma treatment significantly reduced febrile episodes and deaths without increasing HCAIs or carriage. Future work should aim to establish the optimal duration of antibiotic prophylaxis and should involve the laboratory investigation of immunity, inflammation and disease activity on stored samples funded by the TEAMM (Tackling Early Morbidity and Mortality in Myeloma) National Institute for Health Research Efficacy and Mechanism Evaluation grant (reference number 14/24/04). Trial registration Current Controlled Trials ISRCTN51731976. Funding details This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 62. See the NIHR Journals Library website for further project information.

DOES CHLORHEXIDINE WIPE HELP IN REDUCING HOSPITAL ACQUIRED INFECTIONS (HAIS) AMONG CRITICALLY ILL CHILDREN ADMITTED TO A PAEDIATRIC INTENSIVE CARE UNIT?

2021 ◽  
pp. 35-37
Author(s):  
Madhan Kumar ◽  
Jolly Chandran ◽  
Pragathesh Pragathesh ◽  
Ebor Jacob Gnananayagam ◽  
Hema Paul ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Critically Ill ◽  
Paediatric Intensive Care Unit ◽  
Paediatric Intensive Care ◽  
Critically Ill Children ◽  
Intervention Period ◽  
Hospital Acquired Infections ◽  
Hospital Acquired ◽  
Historical Controls

OBJECTIVE: To determine the effect of chlorhexidine wipes in reducing the incidence of hospital acquired infections (HAIs) among critically ill children admitted in Paediatric Intensive Care Unit (PICU). METHODS: An interventional study, wherein enrolled children were wiped with chlorhexidine after routine bath. The incidence of HAIs were noted and compared with data from historical controls of previous year during the same period (pre-intervention). RESULTS: One hundred and ninety nine children in the intervention period were compared with 271 children from pre-intervention period. The numbers of ventilator-days were 777 and 696 respectively for the intervention period and pre-intervention periods. Incidence of ventilator associated pneumonia (VAP) reduced from 12.9/1000 ventilator-days in the pre-intervention period to 6.4/1000 ventilator-days in the intervention period (p=0.1). VAP prevalence was 3.3% in the pre-intervention period as compared to 2.5% in the intervention period (p=0.6). The incidence of CLABSI was 3.6/1000 catheter-days (catheter days: 1377) with prevalence of 2.5% in the intervention period, whereas among the historic controls of the previous year it was 4.2/1000 days (catheter days 1432) with a prevalence of 2.2% (p= 0.8). No untoward effect was reported. CONCLUSION: The use of chlorhexidine wipes in ICU was feasible but did not signicantly decrease HAIs.

VP47 Health Technology Assessment Of Intensive Care Ventilators For Pediatric Patients

2017 ◽  
Vol 33 (S1) ◽  
pp. 168-169
Author(s):  
Francesco Faggiano ◽  
Martina Andellini ◽  
Federico Nocchi ◽  
Carlo Capussotto ◽  
Francesca Sabusco ◽  
...  
Keyword(s):  
Intensive Care ◽  
Economic Evaluation ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Scientific Evidence ◽  
Clinical Effectiveness ◽  
Health Technology ◽  
Assessment Process ◽  
Context Analysis ◽  
Analytic Hierarchy

INTRODUCTION:The purpose of the study was to evaluate different type and manufacturers of intensive care ventilators in order to support the healthcare decision-making process about the choice to adopt the best available technology for ventilation of pediatric patient in intensive care units at Bambino Gesù Children's Hospital.METHODS:The technology assessment process was developed by using a new methodology, the Decision-oriented Health Technology Assessment (HTA) (DoHTA), a new implementation of the European Network for Health Technology Assessment (EUnetHTA) CoreModel, integrating the Analytic Hierarchy Process (1). A literature review was carried out to gather evidence on safety and overall effectiveness of different kind of intensive care ventilators, with several ventilation modalities and strategies. The synthesis of scientific evidence, and results of the specific context analysis resulted in the definition of components of the decisional hierarchy structure, consisting in detailed characteristics of the technology's performances covering the aspects on feasibility, safety, efficacy, costs, and organizational and technical characteristics of the technology. A subgroup of these indicators has been included in a checklist form for the evaluation of different type and manufacturers of intensive care ventilators, each of which was tested in three independent runs performed in three different departments. In addition, an economic evaluation was also carried out.RESULTS:Preliminary DoHTA results showed that the domains with the highest impacts within the evaluation are safety and clinical effectiveness (34.8 percent and 25.7 percent, respectively) followed by organizational aspects, technical characteristics of technology and costs and economic evaluation. The final objective is to define the alternatives’ ranking through a comparison between alternative technologies’ performances.CONCLUSIONS:The technology assessment project allowed to identify strengths and limits of the most recent intensive care ventilator’ models in the specific contexts of use by involving all health professionals interested, and eventually identify the best option for the hospital.

scholarly journals Multi-criteria Decision Analysis for Health Technology Assessment of Intensive Care Ventilators for Pediatric Patients.

2021 ◽  
Author(s):  
Martina Andellini ◽  
Francesco Faggiano ◽  
Sergio Giuseppe Picardo ◽  
Giuseppina Testa ◽  
Daniela Perrotta ◽  
...  
Keyword(s):  
Decision Making ◽  
Intensive Care ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Pediatric Patients ◽  
Healthcare Setting ◽  
Health Technology ◽  
Assessment Process ◽  
Decision Making Process ◽  
Support Tool

Abstract BackgroundThe technological complexity and heterogeneity of intensive care ventilator models currently available on the market together with the heterogeneity in pediatric patients (0 to 18 years old), make the choice of the best machine for pediatric healthcare setting crucial.This paper is aimed at addressing all the critical aspects linked to the implementation of intensive care ventilators in a pediatric setting, highlighting the most relevant technical features and describing the methodology to conduct health technology assessment (HTA) for supporting the decision-making process.Four ventilators models were included in the assessment process. A decision-making support tool (DoHTA method) based on Analytic Hierarchy Process, was applied. 28 Key Performance Indicators (KPIs) were identified, defining the safety, clinical effectiveness, organizational, technical, and economic aspects. The Performance scores of each ventilator have been measured with respect to KPIs integrated with the total cost of ownership (TCO) analysis, leading to a final rank of the four possible technological solutions. ResultsThe final technologies’ performance scores reflected a deliver valued, contextualized, and shared outputs, detecting the most performant technological solution for the specific hospital context. HTA results had informed and supported the pediatric hospital decision-making process. ConclusionsThis study, identifying and discussing the pros and cons of innovative features of ventilators and all the evaluation criteria and aspects to be taken into account during the evaluation process, can be considered as a valuable proof of evidence as well as a reliable and transferable method for conducting a decision making process in a hospital context.

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