Pediatric Fast Fluid Randomized Controlled Trial

McMaster Children's Hospital

Status: Completed

Conditions: Fluid Resuscitation

Treatments: Other: 900 mL of 0.9% Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01494116

11-272

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 4 patient groups

10 mL syringe size

Experimental group

Treatment:

Other: 900 mL of 0.9% Normal Saline

20 mL syringe size

Experimental group

Treatment:

Other: 900 mL of 0.9% Normal Saline

30 mL syringe size

Experimental group

Treatment:

Other: 900 mL of 0.9% Normal Saline

60 mL syringe size

Experimental group

Treatment:

Other: 900 mL of 0.9% Normal Saline