ResuscitationPFFT2NCT01774214
Pediatric Fast Fluid Trial 2
A study testing Push-Pull technique and Disconnect-Reconnect Technique in people with Resuscitation and Shock, run by McMaster Children's Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Resuscitation, Shock, Fluid Therapy
- What is being tested?
- Push-Pull technique and Disconnect-Reconnect Technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2013to May 2013
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rapid Pediatric Fluid Resuscitation: a Randomized Controlled Trial Comparing the Efficiency of Two Provider-Endorsed Manual Fluid Resuscitation Techniques
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
- Being tested
- Push-Pull technique, Disconnect-Reconnect Technique
- Keywords
- Resuscitation, Shock, Fluid Therapy, Pediatrics
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Push-Pull techniqueProcedure or surgery
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.
Disconnect-Reconnect TechniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Push-Pull technique; Procedure: Disconnect-Reconnect Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Date of Subject Randomization until Date Intervention Completed (Day 1)
Secondary outcomes (4)
Accuracy of fluid volume delivery
Total volume of normal saline (mL) effectively administered to the model by the participant
Measured: From Date of Subject Randomization until Date Intervention Completed (Day 1)
Catheter dislodgement event while performing the intervention
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.
Measured: From Date of Subject Randomization until Date Intervention Completed (Day 1)
Self-reported fatigue
Determined based upon responses to the study questionnaire which subjects will be asked to complete following performance of the intervention.
Measured: From Date of Subject Randomization until Date Intervention Completed (Day 1)
Fluid infusion rates for each of the three sequential fluid boluses
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)].
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 posted23 Jan 2013 (estimated)
- Study startApr 2013
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Regional Medical Associates of Hamilton
- 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
- NCT01774214
- Sponsor's protocol ID
- 12-358
- Acronym
- PFFT2
- Status last verified
- Oct 2013
- First submitted
- 19 Jan 2013
- Last updated
- 29 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24993757Cole 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.
PubMed 23524045
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Pediatric Fluid Resuscitation: a Randomized Controlled Trial Comparing the Efficiency of Two Provider-Endorsed Manual Fluid Resuscitation Techniques
- ClinicalTrials.gov ID
- NCT01774214
- Acronym / sponsor ID
- PFFT2 / 12-358
- Conditions
- Resuscitation, Shock, Fluid Therapy, Pediatrics
- Keywords
- Resuscitation, Shock, Fluid Therapy, Pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- McMaster Children's HospitalUniversity, hospital or other
- Collaborators
- Regional Medical Associates of Hamilton
- Study start
- Apr 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 23 Jan 2013 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: Push-Pull technique, Procedure: Disconnect-Reconnect TechniqueAs 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. |
| B | Experimental | Procedure: Push-Pull technique, Procedure: Disconnect-Reconnect TechniqueAs 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Push-Pull techniqueParticipants 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. | Procedure or surgery | A, B |
| Disconnect-Reconnect TechniqueParticipants 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. | Procedure or surgery | A, B |
Primary outcome
Overall fluid infusion rate
Time frame: 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.
4 secondary outcomes
Accuracy of fluid volume delivery
Time frame: From Date of Subject Randomization until Date Intervention Completed (Day 1)
Catheter dislodgement event while performing the intervention
Time frame: From Date of Subject Randomization until Date Intervention Completed (Day 1)
Self-reported fatigue
Time frame: From Date of Subject Randomization until Date Intervention Completed (Day 1)
Fluid infusion rates for each of the three sequential fluid boluses
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 29 Oct 2013.
- Derived from this study: PubMed 24993757Cole 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.
- Derived from this study: PubMed 23524045Cole 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.
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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 Push-Pull technique and Disconnect-Reconnect Technique in people with Resuscitation and Shock, 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 2 inclusion and 3 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 29 Oct 2013. 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?
Overall fluid infusion rate (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 NCT01774214, which also lists 2 linked publications.
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 29 Oct 2013.