Pediatric Fast Fluid Trial 2
- Conditions
- Fluid TherapyShockPediatricsResuscitation
- Interventions
- Procedure: Push-Pull techniqueProcedure: Disconnect-Reconnect Technique
- Registration Number
- NCT01774214
- Lead Sponsor
- McMaster Children's Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description B Disconnect-Reconnect Technique As this is a crossover trial, the study arms denote the order in which the two interventions are performed by the subject. In Arm B, subjects will perform the "Disconnect-Reconnect Technique" of manual fluid resuscitation first, followed by the "Push-Pull Technique" second. A washout period of at least 30 minutes between each of the two interventions will be observed. B Push-Pull technique As this is a crossover trial, the study arms denote the order in which the two interventions are performed by the subject. In Arm B, subjects will perform the "Disconnect-Reconnect Technique" of manual fluid resuscitation first, followed by the "Push-Pull Technique" second. A washout period of at least 30 minutes between each of the two interventions will be observed. A Push-Pull technique As this is a crossover trial, the study arms denote the order in which the two interventions are performed by the subject. In Arm A, subjects will perform the "Push-Pull Technique" of manual fluid resuscitation first, followed by the "Disconnect-Reconnect Technique" second. A washout period of at least 30 minutes between each of the two interventions will be observed. A Disconnect-Reconnect Technique As this is a crossover trial, the study arms denote the order in which the two interventions are performed by the subject. In Arm A, subjects will perform the "Push-Pull Technique" of manual fluid resuscitation first, followed by the "Disconnect-Reconnect Technique" second. A washout period of at least 30 minutes between each of the two interventions will be observed.
- Primary Outcome Measures
Name Time Method Overall fluid infusion rate 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 Outcome Measures
Name Time Method Catheter dislodgement event while performing the intervention From Date of Subject Randomization until Date Intervention Completed (Day 1) Any IV catheter dislodgement events will be recorded by the research assistant at the time of subject testing on the data collection form. The IV catheter is transfixed to the hand of the mannequin in typical clinical fashion. The distal end of the catheter is located within conduit tubing which leads to a 1 litre graduated cylinder. Connected to the proximal aspect (hub) of the IV catheter is a 7 inch long IV Catheter Extension set, which the participant will be in contact with as they administer the intervention.
Accuracy of fluid volume delivery From Date of Subject Randomization until Date Intervention Completed (Day 1) Total volume of normal saline (mL) effectively administered to the model by the participant
Fluid infusion rates for each of the three sequential fluid boluses From Date of Subject Randomization until Date Intervention Completed (Day 1) Bolus 1 rate = 300 mL/Time to effectively administer the first 300 mL of fluid; Bolus 2 rate = 300 mL/Time to effectively administer the second 300 mL of fluid; Bolus 3 rate = Remaining volume effectively administered beyond the first 600 mL/Time to administer this remaining volume. Fluid administration times for Boluses 1, 2 and 3, will be determined based on video review in a similar fashion as for the Primary Outcome \[Volume/(Bolus end time-Bolus start time)\].
Self-reported fatigue From Date of Subject Randomization until Date Intervention Completed (Day 1) Determined based upon responses to the study questionnaire which subjects will be asked to complete following performance of the intervention.
Trial Locations
- Locations (1)
McMaster Children's Hospital
🇨🇦Hamilton, Ontario, Canada