Pediatric Fast Fluid Randomized Controlled Trial

Fluid Resuscitation Clinical Trial

Official title:

Factors Affecting Pediatric Isotonic Fluid Resuscitation Efficiency: Impact of Syringe Size

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01494116
• Other study ID #: 11-272
• Status: Completed
• Phase: N/A
• First received: December 5, 2011
• Last updated: February 26, 2012
• Start date: October 2011
• Est. completion date: January 2012

Study information

• Verified date: February 2012
• Source: McMaster Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Description:

The Surviving Sepsis Guideline for the resuscitation of pediatric septic shock indicates that up to 60 mL/kg of isotonic saline should be administered within the first 15 minutes of resuscitation. There are practical challenges to achieving these benchmarks. Syringes are often used to perform manual fluid resuscitation as they are generally available and health care providers are typically comfortable using them. Health care providers have been observed to have different preferences regarding the syringe size used to perform manual fluid resuscitation. Larger syringes e.g. 60 mL-size requires more force to depress the syringe plunger, due to a larger crosssectional area, but fewer syringes are needed to administer a given volume. Fewer syringes results in less time spent connecting and disconnecting syringes, which contributes to total fluid resuscitation time using this technique.

Consenting participants will be randomly assigned (by an independent Randomization Coordinator) to one of four syringe size groups (10 mL, 20 mL, 30 mL, 60 mL sizes). The allocation sequence is therefore concealed. After undergoing a standardization procedure, each participant will be instructed to administer 900 mL of 0.9% normal saline using pre-filled provided syringes by manual push as rapidly as possible using the disconnect-reconnect method. Participants will be advised to consider that they are in a situation where they are resuscitating a 15 kg child (represented by the model) in decompensated shock. Syringes for each 300 mL (20 mL/kg) aliquot will be colour-coded for identification purposes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fluid Resuscitation

Intervention

Other:
• 900 mL of 0.9% Normal Saline
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.

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences, McMaster Children's Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster Children's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Time to administer each of three sequential 300 mL fluid boluses	Bolus 1 Time = Time at 300 mL administered MINUS Start Intervention Time; Bolus 2 Time = Time at 600 mL administered MINUS Time at 300 mL administered; Bolus 3 Time = Time at 900 mL administered (End Intervention Time) MINUS Time at 600 mL administered.; Syringes are marked with coloured tape to facilitate identification according to Bolus number (Bolus 1 - Green; Bolus 2 - Yellow; Bolus 3 - Red).	From Date of Subject Randomization until Date Intervention Completed (Day 1)	No
Secondary	Amount of normal saline actually administered to the model	The normal saline administered to the model travels via conduit tubing in a dependent fashion to a graduated cylinder where it is collected for measurement upon completion of testing for each subject.	From Date of Subject Randomization until Date Intervention Completed (Day 1)	No
Secondary	The proportion of subjects in each group that dislodge the IV catheter during testing.	Any IV catheter dislodgement episodes will be recorded. The catheter used in this model is a 1.00 inch, 22-gauge, Insyte Autoguard IV catheter. The proximal end (hub) of the IV catheter is transfixed to the hand of the mannequin in typical clinical fashion, while the distal end is located within conduit tubing that leads to a 1 litre graduated cylinder. Connected to the hub of the IV catheter is a 7 inch long IV Catheter Extension Set.	From Date of Subject Randomization until Date Intervention Completed (Day 1)	Yes
Secondary	Self-reported comfort of health care providers while performing the study intervention	Based on responses to questionnaire that subjects are asked to complete following completion of the intervention	From Date of Subject Randomization until Date Intervention Completed (Day 1)	No