Browsing by Author "Joffe, Ari R"

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    Chloral hydrate enteral infusion for sedation in ventilated children: the CHOSEN pilot study
    (2017-11-26) Joffe, Ari R; Hogan, Jessica; Sheppard, Cathy; Tawfik, Gerda; Duff, Jonathan P; Garcia Guerra, Gonzalo
    Abstract Background We aimed to test a novel method of delivery of chloral hydrate (CH) sedation in ventilated critically ill young children. Methods Children < 12 years old, within 72 hours of admission, who were ventilated, receiving enteral tube-feeds, with intermittent CH ordered were enrolled after signed consent. Patients received a CH loading-dose of 10 mg/kg enterally, then a syringe-pump enteral infusion at 5 mg/kg/hour, increasing to a maximum of 9 mg/kg/hour. Cases were compared to historical controls matched for age group and Pediatric Risk of Mortality score (PRISM) category, using Fisher’s exact test and the t test. The primary outcome was feasibility, defined as the use of an enteral CH continuous infusion without discontinuation attributable to a pre-specified potential harm. Results There were 21 patients enrolled, at age 11.4 (12.1) months, with bronchiolitis in 10 (48%), a mean Pediatric Logistic Organ Dysfunction (PELOD) score of 6.2 (5.2), and having received enteral CH continuous infusion for 4.5 (2.2) days. Infusion of CH was feasible in 20/21 (95%; 95% CI 76–99%) patients, with one (5%) adverse event of duodenal ulcer perforation on day 3 in a patient with croup receiving regular ibuprofen and dexamethasone. The CH infusion dose (mg/kg/h) on day 2 (n = 20) was 8.9 (IQR 5.9, 9), and on day 4 (n = 11) was 8.8 (IQR 7, 9). Days to titration of adequate sedation (defined as ≤ 3 PRN doses/shift) was 1 (IQR 0.5, 2.5), and hours to awakening for extubation was 5 (IQR 2, 9). Cases (versus controls) had less positive fluid balance at 48 h (-2 (45) vs. 26 (46) ml/kg, p = 0.051), and a decrease in number of PRN sedation doses from 12 h pre to 12 hours post starting CH (4.7 (3.3) to 2.6 (2.8), p = 0.009 versus 2.9 (3.9) to 3.4 (5), p = 0.74). There were no statistically significant differences between cases and controls in inotrope scores, signs or treatment of withdrawal, or PICU days. Conclusions Delivering CH by continuous enteral infusion is feasible, effective, and may be associated with less positive fluid balance. Whether there is a risk of duodenal perforation requires further study.
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    Identification and Epidemiology of Severe Respiratory Disease due to Novel Swine-Origin Influenza A (H1N1) Virus Infection in Alberta
    (2010-01-01) Zahariadis, George; Joffe, Ari R; Talbot, James; deVilliers, Albert; Campbell, Patricia; Pabbaraju, Kanti; Wong, Sallene; Bastien, Nathalie; Li, Yan; Mitchell, Robyn L; Pang, Xiao-Li; Yanow, Stephanie; Chui, Linda; Predy, Gerald; Willans, David; Lee, Bonita E; Preiksaitis, Jutta K; Clement, Bev; Jacobs, Angela; Jaipaul, Joy; Fonseca, Kevin
    BACKGROUND: In March 2009, global surveillance started detecting cases of influenza-like illness in Mexico. By mid-April 2009, two pediatric patients were identified in the United States who were confirmed to be infected by a novel influenza A (H1N1) strain. The present article describes the first identified severe respiratory infection and the first death associated with pandemic H1N1 (pH1N1) in Canada.METHODS: Enhanced public health and laboratory surveillance for pH1N1 was implemented throughout Alberta on April 24, 2009. Respiratory specimens from all patients with a respiratory illness and travel history or those presenting with a severe respiratory infection requiring hospitalization underwent screening for respiratory viruses using molecular methods. For the first severe case identified and the first death due to pH1N1, histocompatibility leukocyte antigens were compared by molecular methods.RESULTS: The first death (a 39-year-old woman) occurred on April 28, 2009, and on May 1, 2009, a 10-year-old child presented with severe respiratory distress due to pH1N1. Both patients had no travel or contact with anyone who had travelled to Mexico; the cases were not linked. Histocompatibility antigen comparison of both patients did not identify any notable similarity. pH1N1 strains identified in Alberta did not differ from the Mexican strain.CONCLUSION: Rapid transmission of pH1N1 continued to occur in Alberta following the first death and the first severe respiratory infection in Canada, which were identified without any apparent connection to Mexico or the United States. Contact tracing follow-up suggested that oseltamivir may have prevented ongoing transmission of pH1N1.
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    Music Use for Sedation in Critically ill Children (MUSiCC trial): a pilot randomized controlled trial
    (2021-01-12) Garcia Guerra, Gonzalo; Joffe, Ari R; Sheppard, Cathy; Hewson, Krista; Dinu, Irina A; Hajihosseini, Morteza; deCaen, Allan; Jou, Hsing; Hartling, Lisa; Vohra, Sunita
    Abstract Objective To demonstrate feasibility of a music medicine intervention trial in pediatric intensive care and to obtain information on sedation and analgesia dose variation to plan a larger trial. Material and methods Pilot randomized controlled trial (RCT) was conducted at the Stollery Children’s Hospital general and cardiac intensive care units (PICU/PCICU). The study included children 1 month to 16 years of age on mechanical ventilation and receiving sedation drugs. Patients were randomized in a 1:1:1 ratio to music, noise cancellation or control. The music group received classical music for 30 min three times/day using headphones. The noise cancellation group received the same intervention but with no music. The control group received usual care. Results A total of 60 patients were included. Average enrollment rate was 4.8 patients/month, with a consent rate of 69%. Protocol adherence was achieved with patients receiving > 80% of the interventions. Overall mean (SD) daily Sedation Intensity Score was 52.4 (30.3) with a mean (SD) sedation frequency of 9.75 (7.21) PRN doses per day. There was a small but statistically significant decrease in heart rate at the beginning of the music intervention. There were no study related adverse events. Eighty-eight percent of the parents thought the headphones were comfortable; 73% described their child more settled during the intervention. Conclusions This pilot RCT has demonstrated the feasibility of a music medicine intervention in critically ill children. The study has also provided the necessary information to plan a larger trial.
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    Parental opinions regarding consent for observational research of no or minimal risk in the pediatric intensive care unit
    (2019-12-16) Hodson, Jessica; Garros, Christiana; Jensen, Jodie; Duff, Jonathan P; Garcia Guerra, Gonzalo; Joffe, Ari R
    Abstract Background The aim of the study was to determine opinions and knowledge regarding the process of obtaining informed consent to participate in observational research in pediatric intensive care. Methods Survey 1 asked decision makers what model(s) of consent was acceptable for each type of observational research both before and after background information. Survey 2 asked decision makers about the experience of being asked for consent to observational research, and knowledge regarding the consent process both before and after background information. Results Cooperation rate was 100/117 (85%). The proportion in favor of any of the offered alternatives to signed informed consent for observational research, after receiving all the background information, was 74-80%, lowest for observational prospective research with a minimal risk intervention 37/50 (74%; 95% CI 60–84%). The proportion who agreed they felt overwhelmed by being approached for consent to observational research was 26 (52%; 95% CI 39-65%). Most respondents (from 60 to 74%) felt they understood the concepts regarding observational research; however, after reading background information, most (from 60 to 74%) felt their understanding had improved “a great deal”. Conclusion Understanding of risk, practical difficulties, consent bias, and Research Ethics Board safeguards was poor. Future study is needed to confirm our finding that most agreed with alternative methods of consent for observational research.
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    Predictors and outcomes of early post-operative veno-arterial extracorporeal membrane oxygenation following infant cardiac surgery
    (2018-09-03) Kuraim, Gabriela A; Garros, Daniel; Ryerson, Lindsay; Moradi, Fahimeh; Dinu, Irina A; Garcia Guerra, Gonzalo; Moddemann, Diane; Bond, Gwen Y; Robertson, Charlene M T; Joffe, Ari R
    Abstract Background We aimed to determine predictors of, and outcomes after, veno-arterial extracorporeal membrane oxygenation instituted within 48 h after cardiac surgery (early ECMO) in young infants. Methods Patients ≤ 6 weeks old having cardiac surgery from 2003 to 2012 were enrolled prospectively. Patients cannulated pre-operatively, intra-operatively, or ≥ 48 h post-operatively were excluded. Variables at p ≤ 0.1 on univariate regression were entered into multiple logistic regression to predict early ECMO. Early-ECMO cases were matched 1:2 for six demographic variables, and death by age 2 years old (determined using conditional logistic regression; presented as odds ratio (OR), 95% confidence interval (CI)) and General Adaptive Composite scores at age 2 years (determined using Wilcoxon rank sum) were compared; p ≤ 0.05 was considered statistically significant. Results Of 565 eligible patients over the 10-year period, 20 had early ECMO instituted at a mean (standard deviation) of 12.4 (11.4) h post-operatively, 10 of whom had extracorporeal cardiopulmonary resuscitation. Of early-ECMO patients, 8 (40%) were found to have residual anatomic defects requiring intervention with catheterization (n = 1) and/or surgery (n = 7). On multiple regression, the post-operative day 1 highest vasoactive-inotrope score (OR 1.02; 95%CI 1.06,1.08; p < 0.001), highest lactate (OR 1.2; 95%CI 1.06,1.35; p = 0.003), and lowest base deficit (OR 0.82; 95%CI 0.71,0.94; p = 0.004), CPB time (OR 1.01; 95%CI 1.00,1.02; p = 0.002), and single-ventricle anatomy (OR 5.35; 95%CI 1.66,17.31; p = 0.005) were associated with early ECMO. Outcomes at 2 years old compared between early-ECMO and matched patients were mortality 11/20 (55%) vs 11/40 (28%) (OR 3.22, 95%CI 0.98,10.63; p = 0.054) and General Adaptive Composite median 65 [interquartile range (IQR) 58, 81.5] in 9 survivors vs 93 [IQR 86.5, 102.5] in 29 survivors (p = 0.02). Conclusions The identified risk factors for, and outcomes after, having early ECMO may aid decision making in the acute period and confirm that neurodevelopmental follow-up for these children is necessary. The hypothesis that earlier institution of ECMO may improve long-term outcomes requires further study.
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    Publication bias in animal research presented at the 2008 Society of Critical Care Medicine Conference
    (2017-07-07) Conradi, Una; Joffe, Ari R
    Abstract Background To determine a direct measure of publication bias by determining subsequent full-paper publication (P) of studies reported in animal research abstracts presented at an international conference (A). Methods We selected 100 random (using a random-number generator) A from the 2008 Society of Critical Care Medicine Conference. Using a data collection form and study manual, we recorded methodology and result variables from A. We searched PubMed and EMBASE to June 2015, and DOAJ and Google Scholar to May 2017 to screen for subsequent P. Methodology and result variables were recorded from P to determine changes in reporting from A. Predictors of P were examined using Fisher’s Exact Test. Results 62% (95% CI 52–71%) of studies described in A were subsequently P after a median 19 [IQR 9–33.3] months from conference presentation. Reporting of studies in A was of low quality: randomized 27% (the method of randomization and allocation concealment not described), blinded 0%, sample-size calculation stated 0%, specifying the primary outcome 26%, numbers given with denominators 6%, and stating number of animals used 47%. Only being an orally presented (vs. poster presented) A (14/16 vs. 48/84, p = 0.025) predicted P. Reporting of studies in P was of poor quality: randomized 39% (the method of randomization and allocation concealment not described), likely blinded 6%, primary outcome specified 5%, sample size calculation stated 0%, numbers given with denominators 34%, and number of animals used stated 56%. Changes in reporting from A to P occurred: from non-randomized to randomized 19%, from non-blinded to blinded 6%, from negative to positive outcomes 8%, from having to not having a stated primary outcome 16%, and from non-statistically to statistically significant findings 37%. Post-hoc, using publication data, P was predicted by having positive outcomes (published 62/62, unpublished 33/38; p = 0.003), or statistically significant results (published 58/62, unpublished 20/38; p < 0.001). Conclusions Only 62% (95% CI 52–71%) of animal research A are subsequently P; this was predicted by oral presentation of the A, finally having positive outcomes, and finally having statistically significant results. Publication bias is prevalent in critical care animal research.