Factors Affecting Pediatric Isotonic Fluid Resuscitation Efficiency: Impact of Syringe Size
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- McMaster Children's Hospital
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Total Intervention Time
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
10 mL syringe size
Intervention: 900 mL of 0.9% Normal Saline (Other)
20 mL syringe size
Intervention: 900 mL of 0.9% Normal Saline (Other)
30 mL syringe size
Intervention: 900 mL of 0.9% Normal Saline (Other)
60 mL syringe size
Intervention: 900 mL of 0.9% Normal Saline (Other)
Outcomes
Primary Outcomes
Total Intervention Time
Time Frame: From Date of Subject Randomization until Date Intervention Completed (Day 1)
Subject is randomized and the intervention is performed the same day. Start Intervention Time (time zero): Subject begins administering the intervention; End Intervention Time: Subject has completed the intervention (900 mL of Saline has been administered); Total Intervention Time = End Intervention Time - Start Intervention Time. All testing is being video recorded. A blinded outcome assessor will review the video tapes and based upon clear, a priori defined, definitions will determine the Start Intervention Time and the End Intervention Time for each subject.
Secondary Outcomes
- Time to administer each of three sequential 300 mL fluid boluses(From Date of Subject Randomization until Date Intervention Completed (Day 1))
- Amount of normal saline actually administered to the model(From Date of Subject Randomization until Date Intervention Completed (Day 1))
- The proportion of subjects in each group that dislodge the IV catheter during testing.(From Date of Subject Randomization until Date Intervention Completed (Day 1))
- Self-reported comfort of health care providers while performing the study intervention(From Date of Subject Randomization until Date Intervention Completed (Day 1))
Investigators
Melissa J Parker, MD, MSc
Assistant Professor
McMaster Children's Hospital