Exception From Informed Consent for Pediatric Resuscitation Research: Community Consultation for a Trial of Brain Cooling After In-Hospital Cardiac Arrest

PEDIATRICS ◽  
2004 ◽  
Vol 114 (3) ◽  
pp. 776-781 ◽  
Author(s):  
M. C. Morris
CJEM ◽  
2020 ◽  
Vol 22 (S1) ◽  
pp. S63-S63
Author(s):  
F. Besserer ◽  
J. Dirk ◽  
G. Meckler ◽  
J. Tijssen ◽  
A. DeCaen ◽  
...  

Introduction: Intraosseous (IO) and intravenous (IV) access to the vascular system for the delivery of fluid and medication is a component of advanced pediatric resuscitation. Data describing the use of IV or IO vascular access methods and outcomes of pediatric out-of-hospital cardiac arrest (OHCA) are limited. Methods: We analyzed prospectively collected data of non-traumatic OHCA of the Resuscitation Outcomes Consortium registry in Canada and the USA (2011-2015). We included patients 17 years of age and younger who were treated by emergency medical services (EMS). We described the vascular access routes utilized, and the success rate of these attempts. We performed a logistic regression model, to evaluate the association of vascular access route and survival, adjusting for age, sex, shockable initial rhythm, witnessed status, public location, EMS arrival interval and time from 911 call to vascular access. In this model, we excluded patients with failed, multiple site or no vascular access attempts during the resuscitation. Results: Of 1549 non-traumatic pediatric OHCA, 822/895 (92%) and 345/488 (71%) had successful IO and IV vascular access attempts, respectively. IO access was more common in younger cases. Of 761 cases included in the regression model, 30/601 (5%) of IO-treated cases survived to hospital discharge, in comparison to 40/160 (25%) of IV-treated cases. Intraosseous access was associated with a decreased survival to hospital discharge (adjusted OR 0.46; 95% CI 0.21 to 0.98). Conclusion: In pediatric patients with OHCA, intraosseous vascular access was more commonly successful than IV placement and more common among younger cases. However, in cases with successful vascular access, IO use was associated with lower survival to hospital discharge.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_4) ◽  
Author(s):  
Ivie D Esangbedo ◽  
Prakadeshwari Rajapreyar ◽  
Matthew Kirschen ◽  
Richard Hanna ◽  
Dana E Niles ◽  
...  

Introduction: Cerebral near-infrared spectroscopy (NIRS) measuring regional oxygen saturation (rSO 2 ) during cardiopulmonary resuscitation (CPR) is associated with return of spontaneous circulation (ROSC) and survival to hospital discharge (SHD) in adults, with limited data in children. We hypothesized mean cerebral rSO 2 during pediatric in-hospital cardiac arrest (IHCA) would be associated with return of spontaneous circulation (ROSC). Methods: Consecutive case series of pediatric IHCA events with rSO 2 data reported between 2016-2020 by 3 sites to the Pediatric Resuscitation Quality (pediRES-Q) collaborative. We excluded patients with CPR duration ≤2 minutes or who had return of circulation via extracorporeal membrane oxygenation. We calculated mean rSO 2 for duration of CPR and the primary outcome measure was ROSC. Exploratory sensitivity analyses were performed for cutoffs of mean rSO 2 >25, >30, >35, >40 and >50%. Analysis was done using independent samples t test, Exact logistic regression and Fisher’s exact test. Results: Of 36 events (26 index), median age was 3 [IQR 1,7.8] months; 29 (80.5%) had congenital heart disease and 15 (41.7%) had single ventricle (SV) physiology. Median CPR duration was 7.5 [IQR 3.8, 32.2] minutes and 28/36 (77.8%) had ROSC. Mean intra-arrest cerebral rSO 2 was 44.2% (±19.5) for ROSC vs. 37.4% (±15) for non-ROSC group ( p =0.267). Using Exact logistic regression, there was no association found between rSO 2 and ROSC, even after controlling for age, presence of congenital heart disease, and SV physiology. Using mean rSO 2 cutoffs >25, >30, >35, >40, and >50%, we found no significant association with ROSC. We found same result in the SV subgroup. Conclusion: In this small pediatric cohort of predominantly cardiac patients, there was no significant association between cerebral rSO 2 during pediatric cardiac arrest and ROSC, even after controlling for important confounders of age and SV physiology. More extensive studies using larger populations, and evaluating intra-arrest change in cerebral rSO 2 from baseline, are warranted to provide more insight into the possibilities of using rSO 2 to guide CPR.


Circulation ◽  
2021 ◽  
Vol 144 (Suppl_2) ◽  
Author(s):  
Kasper G Lauridsen ◽  
Todd Sweberg ◽  
Sarah E Haskell ◽  
Orsola Gawronski ◽  
Dana E Niles ◽  
...  

Introduction: Survival of adult patients with COVID-19 who had an in-hospital cardiac arrest (IHCA) are poor. Characteristics and outcomes for pediatric IHCA patients with COVID-19 are unknown. Hypothesis: We hypothesized that pediatric COVID-19 patients would have worse survival outcomes when compared to non-COVID patients. Methods: A multicenter, multinational cohort of pediatric IHCA in the pediRES-Q collaborative were reviewed (March 1, 2020 - April 1, 2021). We characterized patients with COVID-19 compared to patients without COVID-19 and investigated whether COVID-19 was associated with survival outcomes using multivariate logistic regression with mixed effects. Results: We identified 362 pediatric IHCAs of which 14 were COVID-19 positive. For non-COVID-19 vs COVID-19 patients respectively, median [Q1; Q3] age was 1.0 [0.3; 7.1] vs. 7.1 [1.5; 14.0] years and 42% vs. 43% were female. Immediate cause of arrest was hypotension: 8% vs. 43%, respiratory decompensation: 19% vs. 21%, and hypoxia 22% vs. 36% for non-COVID-19 vs. COVID-19 patients. For non-COVID-19 vs COVID-19 patients, total CPR duration was 10 [4; 33] min vs 19 [5; 33] min (for non-return of spontaneous circulation (ROSC) cases only: 35 [20; 55] min vs 34 [24; 34] min). For non-COVID-19 vs COVID-19 patients, ROSC was 79% vs. 57%, aOR: 0.48 (95% CI: 0.24-0.98), survival to hospital discharge was 45% vs. 29%, aOR: 0.63 (95% CI: 0.25-1.57) and survival with favorable neurological outcome was 39% vs. 21%, aOR: 0.51 (95% CI: 0.16-1.65). Conclusions: In a pediatric resuscitation quality improvement collaborative, pediatric IHCA patients with COVID-19 were older when compared to non-COVID-19 patients. Median CPR duration was >30 minutes for COVID-19 non-survivors, COVID-19 patients had lower chance of ROSC when compared to non-COVID-19 patients but considerably better survival outcomes than those reported for adults.


Circulation ◽  
2018 ◽  
Vol 138 (Suppl_2) ◽  
Author(s):  
Cindy H Hsu ◽  
Jennifer Fowler ◽  
James A Cranford ◽  
Michael P Thomas ◽  
Robert W Neumar

Introduction: Exception from informed consent (EFIC) enables the enrollment of subjects with emergent conditions for clinical trials without prior consent. All EFIC studies are required to include community consultation (CC). However, CC implementation is often challenged by significant cost and scarce community engagement. Hypothesis: We hypothesize that the utilization of social media, targeted emails, and interviews of at-risk individuals and their caretakers can lead to more effective EFIC CC. Methods: We utilized social media and targeted emails/interviews for the EFIC CC of the ACCESS to the Cardiac Catheterization Laboratory in Patients Without ST-Segment Elevation Myocardial Infarction Resuscitated From Out-of-hospital Ventricular Fibrillation Cardiac Arrest Trial. We disseminated study advertisements with survey links and opt-out option using Facebook/Instagram to our communities and targeted emails to prehospital and cardiology providers. We also interviewed at-risk individuals with cardiac conditions, their caretakers, and patient advocacy groups. Between-group comparisons of proportions were tested using modified chi-squared tests for small sample size. Results: We collected 559 fully or partially completed surveys over an eight-week period. The majority of the surveys (70.5%) were obtained using social media. The mean age was 45 years; 90% were white and 61% were female. Overall, 91.3% believed ACCESS is an important study. The interview group had significantly more loved ones with cardiac arrest than the social media (50% vs 36.7%, p < 0.05) or targeted email (50% vs 23.6%, p < 0.005) group. Compared to the interview group, more from social media (81.8% vs 63.3%, p < 0.05) and targeted email (77.4% vs 63.3, p < 0.05) groups said they would include their loved ones in the study. More from the interview group believed that their opinion would be considered seriously compared to the social media (75.9% vs 62.6%, p < 0.05) and targeted email (75.9% vs 54.5%, p < 0.05) groups. No one opted out from the study. Conclusions: The integration of social media with targeted emails and interviews is an effective approach for EFIC CC. Future work is necessary to determine the perception and best utilization of these strategies for EFIC studies.


Circulation ◽  
2018 ◽  
Vol 138 (Suppl_2) ◽  
Author(s):  
Tia T Raymond ◽  
Jordan Duval-Arnould ◽  
Weilun Quan ◽  
Sam Chai ◽  
Lyndsay Ryerson ◽  
...  

Introduction: Amplitude spectral area (AMSA) predicts successful defibrillation (DF) and return of spontaneous circulation (ROSC) in adults but has not been studied during pediatric in-hospital cardiac arrest (IHCA). Hypothesis: We characterized DF dose and AMSA during pediatric IHCA from a pediatric resuscitation quality (pediRES-Q) collaborative and hypothesized that a threshold value of AMSA could predict successful DF. Methods: Children <18 years with witnessed IHCA, ventricular fibrillation (VF) as the initial rhythm, and those who had complete CPR quality metric data captured from the bedside defibrillator (ZOLL R-Series, Chelmsford, MA) were studied. Energy dose, initial AMSA ( i AMSA) and pre-shock AMSA ( p AMSA) [2.5-sec ECG window before defibrillation] for predicting DF success were calculated, together with receiver operator (ROC) curves. Successful DF (sDF) was defined as return of an organized rhythm 5 seconds after DF. Sustained ROSC was defined as >20 minutes without chest compressions. Events with DF due to ventricular tachycardia, inappropriate shocks (i.e. supraventricular tachycardia, conduction block), unavailable AMSA values, and VF events using <1 J/kg for DF were excluded. Results: Between 2015-2018, 34 subjects (median age 7.4 years [1.3,13.1]; median weight 19.4 kgs [8.9, 41.7]) with IHCA due to VF were enrolled. We analyzed 26 shocks in 18 children < 8 years and 25 shocks in 16 children 8 to <18 years. For children < 8 years, the initial DF median dose/kg was 2.5 [2.3,3.3] J/kg with sDF in 14/26 (54%) shocks and sustained ROSC in 10/18 (56%) children. For those 8 to <18 years, initial DF median dose/kg was 3.0 [2.5,3.4] J/kg with sDF in 10/25 (40%) shocks and sustained ROSC in 10/16 (63%). AMSA was significantly higher prior to sDF than in unsuccessful DF ( p AMSA 19.14±8.11 vs.12.0±7.38 mV-Hz, p = 0.0021; i AMSA 19.08±7.38 vs. 11.04±6.57 mV-Hz, p = 0.0053). Area under the ROC curve was 0.765 for p AMSA and 0.796 for i AMSA. Conclusions: We characterized DF dose and AMSA during pediatric IHCA with an initial rhythm of VF and found that sDF was significantly associated with AMSA >19 mV-Hz. Future studies should determine the AMSA threshold that predicts sDF in children due to differences in heart size and cardiac arrest etiology.


2015 ◽  
Vol 22 (3) ◽  
pp. 347-353 ◽  
Author(s):  
Joshua G. Salzman ◽  
Ralph J. Frascone ◽  
Nathan Burkhart ◽  
Richard Holcomb ◽  
Sandi S. Wewerka ◽  
...  

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