Pediatric Fast Fluid Trial 2

NCT01774214 | Completed

• 1 other identifier: 12-358
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Resuscitation; Shock; Fluid Therapy; Pediatrics

Keywords

Resuscitation; Shock; Fluid Therapy; Pediatrics

Outcome Measures

Primary Outcomes (1)

• Overall fluid infusion rate

  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.

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

Secondary Outcomes (4)

• Accuracy of fluid volume delivery

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

• Catheter dislodgement event while performing the intervention

  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)

• Fluid infusion rates for each of the three sequential fluid boluses

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

Study Arms (2)

A

EXPERIMENTAL

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.

Procedure: Push-Pull technique; Procedure: Disconnect-Reconnect Technique

B

EXPERIMENTAL

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.

Procedure: Push-Pull technique; Procedure: Disconnect-Reconnect Technique

Interventions

Push-Pull technique PROCEDURE

Participants will administer 900 mL (60 mL/kg) of NS to a model of a 15 kg toddler in shock. The intervention is the mode of administration of the fluid. For the "Push-Pull Technique", the 7 cm catheter extension tubing will be connected to one of the three ports of a triple stopcock. A second of the 3 ports of the triple stopcock will be connected to an IV tubing set connected to a 1 L bag of NS. A 60 mL syringe will be connected to the third port of the triple stopcock. On verbal prompt, participants will "pull" fluid from the bag of NS by withdrawing the plunger of the 60 mL syringe, filling it with saline. They will then toggle the switch of the triple stopcock, so that it is "off" to the bag of NS and "open" to IV catheter extension tubing leading to the model. They will then depress the syringe plunger, administering the fluid to the model. These steps will be repeated until each participant believes that they have administered the requested volume of fluid to the model.

A; B

Disconnect-Reconnect Technique PROCEDURE

Participants will administer 900 mL (60 mL/kg) of NS to a model of a 15 kg toddler in shock. The intervention is the mode of administration of the fluid. For the "Disconnect-Reconnect Technique", the proximal end of the 7 cm catheter extension tubing will be capped with a needleless adapter. The subject will be provided with 60 mL syringes filled with NS, rapidly prepared in real time by an assistant. Syringes will be prepared by withdrawing NS from a 1 L bag via a Gambro Accessory spike. The subject will administer the requested volume of NS to the model by 1. grabbing one of the fluid-filled syringes 2. connecting the fluid-filled syringe to the needleless adapter, and 3. depressing the syringe plunger resulting in administration of the NS to the model. These steps will be repeated until the subject believes they have administered the requested volume of NS to the model. Testing will begin on verbal prompt. The subject and assistant will not be permitted to switch roles.

A; B

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster Children's Hospital: lead
• Regional Medical Associates of Hamilton: collaborator

Study Sites (1)

McMaster Children's Hospital

Hamilton, Ontario, L8S4K1, Canada

Location

Related Publications (2)

• 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.

  PMID: 24993757 DERIVED

• 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.

  PMID: 23524045 DERIVED

Related Links

• Protocol Publication

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Melissa J Parker, MD, MSc

  McMaster Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: January 19, 2013
• First Posted: January 23, 2013
• Study Start: April 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: October 29, 2013

Record last verified: 2013-10

Locations

CA (1)