Clinical trial NCT01774214: Pediatric Fast Fluid Trial 2
Official title: Rapid Pediatric Fluid Resuscitation: a Randomized Controlled Trial Comparing the Efficiency of Two Provider-Endorsed Manual Fluid Resuscitation Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resuscitation
Shock
Fluid Therapy
Pediatrics
Keywords: Resuscitation
Shock
Fluid Therapy
Pediatrics
Lead sponsor: McMaster Children's Hospital
Sponsor class: OTHER
Collaborators: name: Regional Medical Associates of Hamilton
First posted: 2013-01-23
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine which of two commonly used methods of manual pediatric fluid resuscitation (The "Push-Pull Technique" vs. the "Disconnect-Reconnect Technique") allows for the most rapid administration of normal saline when this is urgently required.


Eligibility criteria: Inclusion Criteria:

* Health Care Providers working or training at McMaster Children's Hospital, including staff nurses, staff physicians, postgraduate medical trainees, nursing students, and medical students
* may be asked to perform manual fluid resuscitation as part of their clinical care activities

Exclusion Criteria:

* Inability to understand English
* Limited manual dexterity, specifically resulting in an inability to perform manual fluid resuscitation involving syringes
* Have acted in a physically strenuous capacity that may result in significant hand fatigue in the 30 minutes immediately prior to performance of the intervention. Where this is the only criteria limiting subject participation, rescheduling of an alternate testing time will be permitted.

Primary outcomes:
measure: Overall fluid infusion rate
timeFrame: From Date of Subject Randomization until Date Intervention Completed (Day 1)
Secondary outcomes:
measure: Accuracy of fluid volume delivery
timeFrame: From Date of Subject Randomization until Date Intervention Completed (Day 1)
measure: Catheter dislodgement event while performing the intervention
timeFrame: From Date of Subject Randomization until Date Intervention Completed (Day 1)
measure: Self-reported fatigue
timeFrame: From Date of Subject Randomization until Date Intervention Completed (Day 1)
measure: Fluid infusion rates for each of the three sequential fluid boluses
timeFrame: From Date of Subject Randomization until Date Intervention Completed (Day 1)
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
Study officials:
affiliation: McMaster Children's Hospital
name: Melissa J Parker, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cole ET, Harvey G, Urbanski S, Foster G, Thabane L, Parker MJ. Rapid paediatric fluid resuscitation: a randomised controlled trial comparing the efficiency of two provider-endorsed manual paediatric fluid resuscitation techniques in a simulated setting. BMJ Open. 2014 Jul 3;4(7):e005028. doi: 10.1136/bmjopen-2014-005028.
citation: Cole ET, Harvey G, Foster G, Thabane L, Parker MJ. Study protocol for a randomised controlled trial comparing the efficiency of two provider-endorsed manual paediatric fluid resuscitation techniques. BMJ Open. 2013 Mar 21;3(3):e002754. doi: 10.1136/bmjopen-2013-002754.