Search for actively enrolling clinical trials
Pediatric CRI Studies: Part 1 Assessing Dehydration with Compensatory Reserve Index (CRI) Monitoring in Children with Vomiting and Diarrhea
Study ID: STU-2020-1074
in this prospective observational study, children 0-18 year old who present to CMC-Dallas eD with chief complaint of vomiting and/or diarrhea and thus at risk for dehydration when a study research assistant is available will be eligible for study. Research assistant will approach family for inclusion into study. For those who agree, a pulse ox probe will be placed on patient and CRi measurements will be continuously monitored. note while the monitor is on continuously, we will ask for the patients to have standardized CRi measurements where they will be supine and still as possible at the initial inclusion in the study, after interventions such as fluid boluses, and prior to final disposition (Discharge or admission). Care of the patient and final disposition will be at the discretion of the treating physician who will be blinded to the CRi readings. Demographic information, current illness information, initial physician assessment of hydration status of patient (CeDiC), treatments received in the eD and final disposition will be collected and recorded. The CRi values will be evaluated to see if they correlate with estimates of dehydration.
- Cancer Related
- Healthy Volunteers
- UT Southwestern Principal Investigator
- KENNETH YEN
CHILDRENS MEDICAL CENTER OF DALLAS
The purpose of this prospective observational study is to evaluate a relatively new hemodynamic monitoring technology which uses a pulse ox sensor probe and proprietary algorithms interrogated from subjects with simulated blood loss that assesses a measure of hypovolemic compensation called the compensatory reserve index (CRi) (Flashback Technologies, Boulder Co) in pediatric patients with vomiting and diarrhea that present to the emergency Department. We want to evaluate whether the CRi measurement may be used to quantify dehydration in a noninvasive manner. We want to know whether the CRi device is better at classification of dehydration in children than treating physician assessment or the current clinical dehydration scales that are available. Primary objectives: (1). Determine whether CRi measurements correlate with % dehydration in children, as determined by the each of different current clinical estimates of dehydration in children (CeDiC): (a) treating physician estimation/assessment of % dehydration (b) the Gorelick dehydration score (1 month x 5 years of age) (c) the Clinical Dehydration Scale (1 month x 36 months of age); (d) the WHo dehydration scale, and (e) the gold standard of % difference from well weight if available (pre-illness weight x initial weight/pre-illness weight x 100 or (post-illness weight x initial weight)/post-illness x 100). (2). Determine whether CRi measurements accurately identify children with 5% or more dehydration as determined by the CeDiC. Secondary objectives: (1) identify an optimal CRi cut point to predict 5% or more by the CeDiC; (2) Compare the accuracy of CRi cut points to the current CeDiC (3) Determine the accuracy of initial CRi values to identify those children who will get intravenous fluid rehydration (including those for whom the initial plan for rehydration was nothing, oRT, or iV); (4) examine initial CRi and final CRi values of patient's in relation to disposition (those who are admitted to the hospital, in comparison to those who are discharged, including those who are discharged and later return for continued symptoms of dehydration). (5) evaluate various treatment modalities for dehydration (oRT, iV fluid bolus, etc.) on resulting changes in CRi values The Main Hypothesis: initial CRi values among children who present with vomiting and/or diarrhea is directly linearly correlated to clinical estimates of dehydration in children (CeDiC) and able to identify children with 5% or more dehydration. RaTionaLe CRi has not been extensively evaluated in the setting of dehydration in children. its use to potentially guide care and predict disposition warrants future work. With a CRi measurement, we may be able to quantify dehydration in a noninvasive manner by the act of placing a simple pulse oximetry probe on a child's finger and the displaying the CRi [Quote]gas gauge[Quote] value. it may also be better at classification of dehydration in children than physician assessment or the current suboptimal clinical dehydration scales described above. Having a relatively easy to use, noninvasive, accurate and timely marker of dehydration has obvious benefits for the care of children who present with varying degrees of dehydration.