Pediatric Fast Fluid Randomized Controlled Trial

NCT01494116 | Completed

• 1 other identifier: 11-272
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the impact of syringe size on the amount of time it takes a health care provider to administer a known volume (900 mL) of resuscitation fluid to a non-clinical, toddler-sized, model. The investigators hypothesize that syringe size will impact fluid resuscitation time.

Conditions

Fluid Resuscitation

Keywords

Pediatrics; Fluid; Bolus; Resuscitation; Shock

Outcome Measures

Primary Outcomes (1)

• Total Intervention Time

  Subject is randomized and the intervention is performed the same day. Start Intervention Time (time zero): Subject begins administering the intervention; End Intervention Time: Subject has completed the intervention (900 mL of Saline has been administered); Total Intervention Time = End Intervention Time - Start Intervention Time. All testing is being video recorded. A blinded outcome assessor will review the video tapes and based upon clear, a priori defined, definitions will determine the Start Intervention Time and the End Intervention Time for each subject.

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

Secondary Outcomes (4)

• Time to administer each of three sequential 300 mL fluid boluses

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

• Amount of normal saline actually administered to the model

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

• The proportion of subjects in each group that dislodge the IV catheter during testing.

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

• Self-reported comfort of health care providers while performing the study intervention

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

Study Arms (4)

10 mL syringe size

EXPERIMENTAL

Other: 900 mL of 0.9% Normal Saline

20 mL syringe size

EXPERIMENTAL

Other: 900 mL of 0.9% Normal Saline

30 mL syringe size

EXPERIMENTAL

Other: 900 mL of 0.9% Normal Saline

60 mL syringe size

EXPERIMENTAL

Other: 900 mL of 0.9% Normal Saline

Interventions

900 mL of 0.9% Normal Saline OTHER

The intervention consists of the administration of 900 mL of Normal Saline to the model using the "Disconnection- Reconnection" method of manual fluid resuscitation. All syringes (syringe size based on study arm) will be prepared by research staff following subject randomization. Each subject will take the prepared syringes, and sequentially administer them to the model by 1. Selecting and connecting a fluid-filled syringe to the catheter extension set to permit fluid administration 2. Manually administering the fluid to the model by depressing the syringe plunger 3. Disconnecting and discarding the empty syringe 4. Repeating steps 1-3 as fast as possible until all 900 mL has been administered.

Also known as: BD 10 mL syringe with Luer-Lok Tip (Ref 309604), BD 20 mL syringe with Luer-Lok Tip (Ref 309661), BD 30 mL syringe with Luer-Lok Tip (Ref 309650), BD 60 mL syringe with Luer-Lok Tip (Ref 309653)

10 mL syringe size; 20 mL syringe size; 30 mL syringe size; 60 mL syringe size

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Consenting health care staff and health care students capable of performing manual syringe bolus fluid administration

You may not qualify if:

• Non-English speaking individuals
• Any condition that would impact upon the individual's ability to perform manual fluid resuscitation e.g. limited hand strength or dexterity

Sponsors & Collaborators

• McMaster Children's Hospital: lead

Study Sites (1)

Hamilton Health Sciences, McMaster Children's Hospital

Hamilton, Ontario, L8N3Z5, Canada

Location

Related Publications (1)

• Harvey G, Foster G, Manan A, Thabane L, Parker MJ. Factors affecting pediatric isotonic fluid resuscitation efficiency: a randomized controlled trial evaluating the impact of syringe size. BMC Emerg Med. 2013 Jul 24;13:14. doi: 10.1186/1471-227X-13-14.

  PMID: 23883424 DERIVED

MeSH Terms

Conditions

Shock

Interventions

Saline Solution; Syringes

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Equipment and Supplies

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: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 16, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: February 28, 2012

Record last verified: 2012-02

Locations

CA (1)