NCT01494116

Pediatric Fast Fluid Randomized Controlled Trial

Factors Affecting Pediatric Isotonic Fluid Resuscitation Efficiency: Impact of Syringe Size

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: McMaster Children's Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Fluid Resuscitation

Interventions

Type	Name	Description
OTHER	900 mL of 0.9% Normal Saline	The intervention consists of the administration of 900 mL of Normal Saline to the model using the "Disconnection- Reconnection" method of manual fluid resuscitation. All syringes (syringe size based on study arm) will be prepared by research staff following subject randomization. Each subject will take the prepared syringes, and sequentially administer them to the model by 1. Selecting and connecting a fluid-filled syringe to the catheter extension set to permit fluid administration 2. Manually administering the fluid to the model by depressing the syringe plunger 3. Disconnecting and discarding the empty syringe 4. Repeating steps 1-3 as fast as possible until all 900 mL has been administered.

Timeline

• Start date: 2011-10-01
• Primary completion: 2011-12-01
• Completion: 2012-01-01
• First posted: 2011-12-16
• Last updated: 2012-02-28

Locations

1 site across 1 country: Canada