Clinical trial NCT01494116: Pediatric Fast Fluid Randomized Controlled Trial
Official title: Factors Affecting Pediatric Isotonic Fluid Resuscitation Efficiency: Impact of Syringe Size
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Resuscitation
Keywords: Pediatrics
Fluid
Bolus
Resuscitation
Shock
Lead sponsor: McMaster Children's Hospital
Sponsor class: OTHER
First posted: 2011-12-16
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the impact of syringe size on the amount of time it takes a health care provider to administer a known volume (900 mL) of resuscitation fluid to a non-clinical, toddler-sized, model. The investigators hypothesize that syringe size will impact fluid resuscitation time.

Detailed description: The Surviving Sepsis Guideline for the resuscitation of pediatric septic shock indicates that up to 60 mL/kg of isotonic saline should be administered within the first 15 minutes of resuscitation. There are practical challenges to achieving these benchmarks. Syringes are often used to perform manual fluid resuscitation as they are generally available and health care providers are typically comfortable using them. Health care providers have been observed to have different preferences regarding the syringe size used to perform manual fluid resuscitation. Larger syringes e.g. 60 mL-size requires more force to depress the syringe plunger, due to a larger crosssectional area, but fewer syringes are needed to administer a given volume. Fewer syringes results in less time spent connecting and disconnecting syringes, which contributes to total fluid resuscitation time using this technique.

Consenting participants will be randomly assigned (by an independent Randomization Coordinator) to one of four syringe size groups (10 mL, 20 mL, 30 mL, 60 mL sizes). The allocation sequence is therefore concealed. After undergoing a standardization procedure, each participant will be instructed to administer 900 mL of 0.9% normal saline using pre-filled provided syringes by manual push as rapidly as possible using the disconnect-reconnect method. Participants will be advised to consider that they are in a situation where they are resuscitating a 15 kg child (represented by the model) in decompensated shock. Syringes for each 300 mL (20 mL/kg) aliquot will be colour-coded for identification purposes.

Eligibility criteria: Inclusion Criteria:

* Consenting health care staff and health care students capable of performing manual syringe bolus fluid administration

Exclusion Criteria:

* Non-English speaking individuals
* Any condition that would impact upon the individual's ability to perform manual fluid resuscitation e.g. limited hand strength or dexterity

Primary outcomes:
measure: Total Intervention Time
timeFrame: From Date of Subject Randomization until Date Intervention Completed (Day 1)
Secondary outcomes:
measure: Time to administer each of three sequential 300 mL fluid boluses
timeFrame: From Date of Subject Randomization until Date Intervention Completed (Day 1)
measure: Amount of normal saline actually administered to the model
timeFrame: From Date of Subject Randomization until Date Intervention Completed (Day 1)
measure: The proportion of subjects in each group that dislodge the IV catheter during testing.
timeFrame: From Date of Subject Randomization until Date Intervention Completed (Day 1)
measure: Self-reported comfort of health care providers while performing the study intervention
timeFrame: From Date of Subject Randomization until Date Intervention Completed (Day 1)
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences, McMaster Children's Hospital
state: Ontario
Study officials:
affiliation: McMaster Children's Hospital
name: Melissa J Parker, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harvey G, Foster G, Manan A, Thabane L, Parker MJ. Factors affecting pediatric isotonic fluid resuscitation efficiency: a randomized controlled trial evaluating the impact of syringe size. BMC Emerg Med. 2013 Jul 24;13:14. doi: 10.1186/1471-227X-13-14.