Hydration Status Evaluation of Dehydrated Children With Experimental Devices
Condition: Dehydration
MeSH terms: Dehydration
Study type: Interventional

Summary: 
      A pediatric study in collaboration with Boston Children's Hospital to review the performance
      of two novel hydration status measurement devices against standard clinical assessment
      methods, through repeated measurement of hydration status of dehydrated children admitted to
      the emergency department receiving rehydration therapy, followed by an at-home follow-up
      measurement once symptoms have resolved.
    

Detailed description: 
      This is a prospective cohort study to determine the performance of two prototype devices
      developed to aid in the diagnosis and monitoring of physiological hydration state of
      dehydrated children. These children are patients presenting to the emergency department with
      varying degrees of dehydration.

      Overview of study procedure:

        1. Initial identification of eligible patients. Patients will be initially identified by
           their chief complaint after registration and triage. Terms such as "Dehydration",
           "Gastroenteritis", "Diarrhea", "Vomiting", and or "Intolerance of POs" will be noted and
           those patients will be approached by study personnel for possible participation in the
           study.

        2. Screening and obtaining of consent After patients have been identified as meeting entry
           criteria for the study, the parents will be asked two screening questions: 1. How far of
           a distance do you live from the hospital? 2. Would you be interested in a study that
           includes a follow-up home visit? These questions will be used to gauge the ability of
           the family to realistically complete the study, as a research coordinator will be
           travelling to the home to conduct a follow up visit after symptom resolution.

        3. Study enrollment i. Risks and benefits of study participation will be discussed, as well
           as the consent process. After consent is obtained, a symptom survey will be administered
           to each patient and family to determine the degree of dehydration based on clinical
           assessment. Detailed information regarding onset and degree of symptoms including
           vomiting, diarrhea, urine output and amount of oral fluid intake will be recorded. A
           similar survey was administered as part of a randomized control trial of Dextrose
           containing fluids, which was conducted in our Emergency Department, (Levy, Waltzman).

           ii. Each patient will have his/her weight obtained using a calibrated digital scale in a
           dry diaper or underwear with an appropriately sized gown. Then both study devices will
           be utilized by study personnel to obtain three triplicate measurements. Replicate
           measurements of capillary refill times will also be obtained in the same locations by
           visual inspection using a commercial stopwatch. Additional information including ambient
           room temperature, patient skin temperature and amount of applied pressure during the
           Capillary Refill Time measurements will be recorded.

           iii. After the initial measurements are obtained, the treating provider will be given a
           questionnaire outlining their assessment of the degree of dehydration of the patient and
           the study protocol. Patients will be treated per the discretion of the health care
           provider including admission to the hospital or discharge based on his or her clinical
           judgment. Device measurements will not be provided to the treating clinician.
           Measurements obtained from the device will have no bearing on the clinical treatment of
           the patients. All measurements obtained in relation to the study will be used solely for
           research purposes. Device measurements of capillary refill time and radio-frequency
           measurements, and initial weight will not be disclosed to treating staff.

           iv. Prior to either discharge from the emergency department or admission to the
           hospital, each participating family will be given a symptom log to serve as a method for
           objectively tracking degree of symptoms during the follow up period.

        4. Initial follow up and monitoring of symptom resolution:

           A research coordinator will call each patient's family by phone within 24-72 hours after
           initial enrollment. He or she will establish contact with the family and explain the
           follow up plan and monitoring for symptom resolution. Regular follow up by phone every
           48 hours will continue until the symptoms have resolved; at which time an in-person
           follow up visit will be planned within 24-72 hours.

        5. In-person follow-up After the resolution of symptoms (vomiting and/or diarrhea), the
           research coordinator will travel to the residence of each patient and repeat the
           measurements including weight and device measurements. Again the weight will be
           performed on a calibrated digital scale with the patient in a dry diaper or underwear
           and an appropriately sized gown. Also, the study coordinator will ask the family/patient
           to answer questions related to the duration of the illness, and other visits with
           medical providers that have occurred in the interim. The radio-frequency and capillary
           refill time measurements will be stored in a secure de-identified server, and all
           remaining data will be recorded entered into a password-protected digital database using
           RedCap.
    

Intervention name(s): Formalized clinical assessment of hydration status; Take a measurement of body weight on calibrated scales; "RF wristband" hydration status measurement; Measure capillary refill time with manual stopwatch; "CRT device" hydration status measurement
Intervention type(s): Other; Other; Device; Other; Device
Intervention description(s): Undertake and record a standard formalized clinical hydration assessment; Standard body weight measurements conducted on calibrated scales; Take measurements with "RF wristband" radio-frequency non-invasive wrist-based hydration status assessment device; A standard visual assessment of capillary refill time, aided by the use of a stopwatch; Take measurements with "CRT device" for non-invasively quantitatively assessing Capillary Refill Time
Intervention model: Single Group Assignment
Primary purpose: Diagnostic
Keywords: Dehydration; Children; Measurement