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

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.

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.

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.

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

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

Protocol Registered on ClinicalTrials.gov NCT01774214.