Study protocol for a randomised controlled trial comparing the efficiency of two provider-endorsed manual paediatric fluid resuscitation techniques

Abstract

Introduction: Paediatric shock is a life-threatening condition with many possible causes and a global impact. Current resuscitation guidelines require rapid fluid administration as a cornerstone of paediatric shock management. However, little evidence is available to inform clinicians how to most effectively perform rapid fluid administration where this is clinically required, resulting in suboptimal knowledge translation of current resuscitation guidelines into clinical practice.

Objectives: This study aims to determine which of the two commonly used techniques for paediatric fluid resuscitation (disconnect-reconnect technique and push-pull technique) yields a higher fluid administration rate in a simulated clinical scenario. Secondary objectives include determination of catheter dislodgement rates, subjective and objective measures of provider fatiguability and descriptive information regarding any technical issues encountered with performance of each method under the study.

Methods and analysis: This study will utilise a randomised crossover trial design. Participants will include consenting healthcare providers from McMaster Children's Hospital. Each participant will administer 900 ml (60 ml/kg) of normal saline to a simulated 15 kg infant as quickly as possible on two separate occasions using the manual fluid administration techniques under the study. The primary outcome, rate of fluid administration, will be evaluated using a paired two-tailed Student t test.

Ethics and dissemination: This protocol has been approved by the Hamilton Health Sciences Research Ethics Board.

Results: These will be published in a peer-reviewed scientific journal and presented at one or more scientific conferences.

Protocol registration: Protocol Registered on ClinicalTrials.gov NCT01774214.

Figures

Figure 1

The ‘disconnection–reconnection’ technique for fluid bolus delivery involves two HCPs. (A, B) One HCP rapidly prepares fluid-filled syringes. (C) A second HCP takes and connects a fluid-filled syringe to the IV extension tubing and administers the fluid to the patient by depressing the syringe plunger. The empty syringe is then disconnected and the process repeated until the desired volume of fluid has been administered.

Figure 2

The ‘push–pull’ technique for fluid bolus delivery involves one HCP. (A) The stopcock is positioned ‘off’ to the patient. The HCP ‘pulls’ the syringe plunger to draw fluid into the syringe from the bag of saline. (B) The stopcock is then toggled 180 degrees, turning this ‘on’ to the patient. (C) The HCP then ‘pushes’ the syringe plunger to administer the fluid. The process is repeated until fluid resuscitation is complete.

Figure 3

A randomised crossover trial design will be used. This design helps to reduce between group variability by having each participant perform each of the interventions under study. The order in which the interventions are performed is determined by randomisation, to control for any potential training or leaning effect. A washout period is included between interventions to allow for participant recovery from any resulting fatigue.