Fluid ResuscitationNCT01494116
Pediatric Fast Fluid Randomized Controlled Trial
A study testing 900 mL of 0.9% Normal Saline in people with Fluid Resuscitation, run by McMaster Children's Hospital at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fluid Resuscitation
- What is being tested?
- 900 mL of 0.9% Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2011to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Consenting health care staff and health care students capable of performing manual syringe bolus fluid administration
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hamilton Health Sciences, McMaster Children's Hospital
Hamilton, Ontario, L8N3Z5
About this study
Official title: Factors Affecting Pediatric Isotonic Fluid Resuscitation Efficiency: Impact of Syringe Size
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.
Read the detailed 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.
- Conditions
- Fluid Resuscitation
- Being tested
- 900 mL of 0.9% Normal Saline
- Keywords
- Pediatrics, Fluid, Bolus, Resuscitation, Shock
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
900 mL of 0.9% Normal SalineOther
Also called 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)
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.
| Study group | Role | What they receive |
|---|---|---|
| 10 mL syringe size | Experimental | Not described Receives: Other: 900 mL of 0.9% Normal Saline |
| 20 mL syringe size | Experimental | Not described Receives: Other: 900 mL of 0.9% Normal Saline |
| 30 mL syringe size | Experimental | Not described Receives: Other: 900 mL of 0.9% Normal Saline |
| 60 mL syringe size | Experimental | Not described Receives: Other: 900 mL of 0.9% Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: From Date of Subject Randomization until Date Intervention Completed (Day 1)
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.
Measured: 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.
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.
Measured: From Date of Subject Randomization until Date Intervention Completed (Day 1)
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
Measured: From Date of Subject Randomization until Date Intervention Completed (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fluid ResuscitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa J Parker, MD, MSc, McMaster Children's Hospital
- Investigators
- Melissa J Parker, MD, MSc, Principal investigator, McMaster Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01494116
- Sponsor's protocol ID
- 11-272
- Status last verified
- Feb 2012
- First submitted
- 5 Dec 2011
- Last updated
- 28 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23883424
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting Pediatric Isotonic Fluid Resuscitation Efficiency: Impact of Syringe Size
- ClinicalTrials.gov ID
- NCT01494116
- Acronym / sponsor ID
- 11-272
- Conditions
- Fluid Resuscitation
- Keywords
- Pediatrics, Fluid, Bolus, Resuscitation, Shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- McMaster Children's HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 16 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Consenting health care staff and health care students capable of performing manual syringe bolus fluid administration
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 900 mL of 0.9% Normal SalineAlso: 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)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. | Other | 10 mL syringe size, 20 mL syringe size, 30 mL syringe size, 60 mL syringe size |
Primary outcome
Total Intervention Time
Time frame: From Date of Subject Randomization until Date Intervention Completed (Day 1)
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.
4 secondary outcomes
Time to administer each of three sequential 300 mL fluid boluses
Time frame: From Date of Subject Randomization until Date Intervention Completed (Day 1)
Amount of normal saline actually administered to the model
Time frame: 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.
Time frame: From Date of Subject Randomization until Date Intervention Completed (Day 1)
Self-reported comfort of health care providers while performing the study intervention
Time frame: From Date of Subject Randomization until Date Intervention Completed (Day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2012.
- Derived from this study: PubMed 23883424Harvey 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.
Related trials for Fluid Resuscitation
Active, not recruiting
BIA-Guided vs. Conventional Fluid Resuscitation in ICU Patients
Fluid and Electrolyte Imbalance, Anesthesia
Recruiting
Personalized Fluid Resuscitation in the Emergency Department: A Pilot Trial
Sepsis, Septic Shock
Not yet recruitingObservational study
Effect of Albumin Therapy in Mechanically Ventilated Patients With Sepsis-Associated ARDS
Acute Respiratory Distress Syndrome, Sepsis
Recruiting
Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients
Septic Shock
Not yet recruitingObservational study
Inferior Vena Cava Versus Subclavian Vein Collapsibility for Predicting Fluid Responsiveness in Trauma Hemorrhagic Shock
Hemorrhagic Shock, Trauma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa J Parker, MD, MSc principal investigator
McMaster Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 900 mL of 0.9% Normal Saline in people with Fluid Resuscitation, run by McMaster Children's Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Intervention Time (time frame: From Date of Subject Randomization until Date Intervention Completed (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01494116, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2012.