Pilot randomized controlled trial of restricted versus liberal crystalloid fluid management in pediatric post-operative and trauma patients.

BACKGROUND: Intravenous (IV) fluid therapy is essential in the treatment of critically ill pediatric surgery and trauma patients. Recent studies have suggested that aggressive fluids may be detrimental to patients. Prospective studies are needed to compare liberal to restricted fluid management in these patients. The primary objective of this pilot trial is to test study feasibility-recruitment and adherence to the study treatment algorithm. METHODS: We conducted a two-part pilot randomized controlled trial (RCT) comparing liberal to restricted crystalloid fluid management in 50 pediatric post-operative (1-18 years) and trauma (1-15 years) patients admitted to our pediatric intensive care unit (PICU). Patients were randomized to a high (liberal) volume or low (restricted) volume algorithm using unblinded, blocked randomization. A revised treatment algorithm was used after the 29th patient for the second part of the RCT. The goal of the trial was to determine the feasibility of conducting an RCT at a single site for recruitment and retention. We also collected data on the safety of study interventions and clinical outcomes, including pulmonary, infectious, renal, post-operative, and length of stay outcomes. RESULTS: Fifty patients were randomized to either liberal (n = 26) or restricted (n = 24) fluid management strategy. After data was obtained on 29 patients, a first study analysis was performed. The volume of fluid administered and triggers for intervention were adapted to optimize the treatment effect and clarity of outcomes. Updated and refined fluid management algorithms were created. These were used for the second part of the RCT on patients 30-50. During this second study period, 54% (21/39, 95% CI 37-70%) of patients approached were enrolled in the study. Of the patients enrolled, 71% (15/21, 95% CI 48-89%) completed the study. This met our a priori recruitment and retention criteria for success. A data safety monitoring committee concluded that no adverse events were related to study interventions. Although the study was not powered to detect differences in outcomes, after the algorithm was revised, we observed a non-significant trend towards improved pulmonary outcomes in patients on the restricted arm, including decreased need for and time on oxygen support and decreased need for mechanical ventilation. CONCLUSION: We demonstrated the feasibility and safety of conducting a single-site RCT comparing liberal to restricted crystalloid fluid management in critically ill pediatric post-operative and trauma patients. We observed trends in improved pulmonary outcomes in patients undergoing restricted fluid management. A definitive multicenter RCT comparing fluid management strategies in these patients is warranted. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04201704 . Registered 17 December 2019-retrospectively registered.

Pediatric Cervical Spine Injury Following Blunt Trauma in Children Younger Than 3 Years: The PEDSPINE II Study.

Importance: There is variability in practice and imaging usage to diagnose cervical spine injury (CSI) following blunt trauma in pediatric patients. Objective: To develop a prediction model to guide imaging usage and to identify trends in imaging and to evaluate the PEDSPINE model. Design, Setting, and Participants: This cohort study included pediatric patients (<3 years years) following blunt trauma between January 2007 and July 2017. Of 22 centers in PEDSPINE, 15 centers, comprising level 1 and 2 stand-alone pediatric hospitals, level 1 and 2 pediatric hospitals within an adult hospital, and level 1 adult hospitals, were included. Patients who died prior to obtaining cervical spine imaging were excluded. Descriptive analysis was performed to describe the population, use of imaging, and injury patterns. PEDSPINE model validation was performed. A new algorithm was derived using clinical criteria and formulation of a multiclass classification problem. Analysis took place from January to October 2022. Exposure: Blunt trauma. Main Outcomes and Measures: Primary outcome was CSI. The primary and secondary objectives were predetermined. Results: The current study, PEDSPINE II, included 9389 patients, of which 128 (1.36%) had CSI, twice the rate in PEDSPINE (0.66%). The mean (SD) age was 1.3 (0.9) years; and 70 patients (54.7%) were male. Overall, 7113 children (80%) underwent cervical spine imaging, compared with 7882 (63%) in PEDSPINE. Several candidate models were fitted for the multiclass classification problem. After comparative analysis, the multinomial regression model was chosen with one-vs-rest area under the curve (AUC) of 0.903 (95% CI, 0.836-0.943) and was able to discriminate between bony and ligamentous injury. PEDSPINE and PEDSPINE II models' ability to identify CSI were compared. In predicting the presence of any injury, PEDSPINE II obtained a one-vs-rest AUC of 0.885 (95% CI, 0.804-0.934), outperforming the PEDSPINE score (AUC, 0.845; 95% CI, 0.769-0.915). Conclusion and Relevance: This study found wide clinical variability in the evaluation of pediatric trauma patients with increased use of cervical spine imaging. This has implications of increased cost, increased radiation exposure, and a potential for overdiagnosis. This prediction tool could help to decrease the use of imaging, aid in clinical decision-making, and decrease hospital resource use and cost.

High volume crystalloid resuscitation adversely affects pediatric trauma patients.

BACKGROUND: Aggressive fluid resuscitative strategies have been the cornerstone of early trauma management for decades. However, recent prospective adult studies have challenged this practice, underlining the detrimental effect of positive fluid balance on cardiopulmonary function. Fluid overload has been associated with impaired oxygenation and morbidity in critically ill adults, but data is lacking in pediatric trauma patients. METHODS: We completed a retrospective chart review of all pediatric trauma patients 0-18 years old admitted to a level 1 trauma center from January 2013 to December 2015. Four patient cohorts were established based on volume of fluid administered: <20 ml/kg/day, 20-40 ml/kg/day, 40-60 ml/kg/day, and > 60 ml/kg/day. The primary outcome was death. Secondary outcomes included the number of days on the ventilator, intensive care unit length of stay (ICU LOS), overall length of stay (LOS), number of days nil per os (NPO) as an indicator of ileus, and incidence of bloodstream infection and/or surgical site infection. RESULTS: The mean volume of fluid administered over the first 24 h was 41 ml/kg/day, and 28 ml/kg/day over the first 48 h. ICU length of stay and overall length of stay were increased in patients who received more than 60 ml/kg/day in the first 24 h of their hospitalization. Furthermore, ventilator use, ICU length of stay, overall length of stay, and time to resumption of a regular diet were all increased in patients who received >60 ml/kg/day over 48 h. CONCLUSIONS: Early administration of high volumes of crystalloid fluid greater than 60 ml/kg/day significantly correlates with pulmonary complications, days NPO, and hospital length of stay. These results span the first 48 h of a patient's hospital stay and should encourage surgical care providers to exercise judicious use of crystalloid fluid administration in the trauma bay, ICU, and floor. TYPE OF STUDY: Therapeutic. LEVEL OF EVIDENCE: Level III.

Utility of a cervical spine clearance protocol after trauma in children between 0 and 3 years of age.

OBJECT: Cervical spine clearance after trauma in children 0-3 years of age is deceptively difficult. Young children may not be able to communicate effectively, and severe injuries may require intubation and sedation. Currently, no published guidelines are available to aid in decision-making in these complex situations. The purpose of this study was to determine whether a safe and effective protocol-driven system could be developed for clearance of the cervical spine in noncommunicative children between 0 and 3 years of age. METHODS: Children 0-3 years of age, including intubated patients, who were admitted after trauma activation at Primary Children's Medical Center in Salt Lake City or the Children's Hospital of New York from 2002 to 2006 were managed according to a cervical spine clearance protocol. Data were collected in a prospective fashion. Radiographic and clinical methods of clearing the cervical spine, as well as the type and management of injuries, were recorded. RESULTS: A total of 2828 pediatric trauma activations required cervical spine clearance during the study period. Of these, 575 (20%) were children