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Clinical Trials/NCT01774214
NCT01774214
Completed
N/A

Rapid Pediatric Fluid Resuscitation: a Randomized Controlled Trial Comparing the Efficiency of Two Provider-Endorsed Manual Fluid Resuscitation Techniques

McMaster Children's Hospital1 site in 1 country16 target enrollmentApril 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Resuscitation
Sponsor
McMaster Children's Hospital
Enrollment
16
Locations
1
Primary Endpoint
Overall fluid infusion rate
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
May 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Melissa J Parker, MD, MSc

Assistant Professor of Pediatrics

McMaster Children's Hospital

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.

Outcomes

Primary Outcomes

Overall fluid infusion rate

Time Frame: From Date of Subject Randomization until Date Intervention Completed (Day 1)

Start Intervention Time is defined as the time that the model begins to effectively receive normal saline as administered by the participant, determined by the time at which fluid begins to collect in the graduated cylinder. End Intervention Time is defined as the time at which the model ceases to effectively receive further normal saline as determined by the time at which fluid stops collecting in the graduated cylinder. All testing will be videorecorded, with video reviews conducted by two independent and blinded outcome assessors using strict criteria to determine total intervention time (Total intervention time = end intervention time - start intervention time). At the time of subject testing, the research assistant will also record the total amount of normal saline collected in the graduated cylinder at the end of the intervention. Total intervention rate (mL/s) = volume of normal saline collected/Total intervention time.

Secondary Outcomes

  • Catheter dislodgement event while performing the intervention(From Date of Subject Randomization until Date Intervention Completed (Day 1))
  • Accuracy of fluid volume delivery(From Date of Subject Randomization until Date Intervention Completed (Day 1))
  • Fluid infusion rates for each of the three sequential fluid boluses(From Date of Subject Randomization until Date Intervention Completed (Day 1))
  • Self-reported fatigue(From Date of Subject Randomization until Date Intervention Completed (Day 1))

Study Sites (1)

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