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Study protocol for a randomised controlled trial comparing the efficiency of two provider-endorsed manual paediatric fluid resuscitation techniques.

ABSTRACT: Paediatric shock is a life-threatening condition with many possible causes and a global impact. Current resuscitation guidelines require rapid fluid administration as a cornerstone of paediatric shock management. However, little evidence is available to inform clinicians how to most effectively perform rapid fluid administration where this is clinically required, resulting in suboptimal knowledge translation of current resuscitation guidelines into clinical practice.This study aims to determine which of the two commonly used techniques for paediatric fluid resuscitation (disconnect-reconnect technique and push-pull technique) yields a higher fluid administration rate in a simulated clinical scenario. Secondary objectives include determination of catheter dislodgement rates, subjective and objective measures of provider fatiguability and descriptive information regarding any technical issues encountered with performance of each method under the study.This study will utilise a randomised crossover trial design. Participants will include consenting healthcare providers from McMaster Children's Hospital. Each participant will administer 900 ml (60 ml/kg) of normal saline to a simulated 15 kg infant as quickly as possible on two separate occasions using the manual fluid administration techniques under the study. The primary outcome, rate of fluid administration, will be evaluated using a paired two-tailed Student t test.This protocol has been approved by the Hamilton Health Sciences Research Ethics Board.These will be published in a peer-reviewed scientific journal and presented at one or more scientific conferences.Protocol Registered on ClinicalTrials.gov NCT01774214.

SUBMITTER: Cole ET

PROVIDER: S-EPMC3612816 | biostudies-literature | 2013 Mar

REPOSITORIES: biostudies-literature

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Study protocol for a randomised controlled trial comparing the efficiency of two provider-endorsed manual paediatric fluid resuscitation techniques.

Cole Evan T ET Harvey Greg G Foster Gary G Thabane Lehana L Parker Melissa J MJ

BMJ open 20130321 3

<h4>Introduction</h4>Paediatric shock is a life-threatening condition with many possible causes and a global impact. Current resuscitation guidelines require rapid fluid administration as a cornerstone of paediatric shock management. However, little evidence is available to inform clinicians how to most effectively perform rapid fluid administration where this is clinically required, resulting in suboptimal knowledge translation of current resuscitation guidelines into clinical practice.<h4>Obje ...[more]

PMID: 23524045

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Project description:ObjectivesManual techniques of intravascular fluid administration are commonly used during paediatric resuscitation, although it is unclear which technique is most efficient in the hands of typical healthcare providers. We compared the rate of fluid administration achieved with the disconnect-reconnect and push-pull manual syringe techniques for paediatric fluid resuscitation in a simulated setting.MethodsThis study utilised a randomised crossover trial design and enrolled 16 consenting healthcare provider participants from a Canadian paediatric tertiary care centre. The study was conducted in a non-clinical setting using a model simulating a 15 kg child in decompensated shock. Participants administered 900 mL (60 mL/kg) of normal saline to the simulated patient using each of the two techniques under study. The primary outcome was the rate of fluid administration, as determined by two blinded independent video reviewers. We also collected participant demographic data and evaluated other secondary outcomes including total volume administered, number of catheter dislodgements, number of technical errors, and subjective and objective measures of provider fatigue.ResultsAll 16 participants completed the trial. The mean (SD) rate of fluid administration (mL/s) was greater for the disconnect-reconnect technique at 1.77 (0.145) than it was for the push-pull technique at 1.62 (0.226), with a mean difference of 0.15 (95% CI 0.055 to 0.251; p=0.005). There was no difference in mean volume administered (p=0.778) or participant self-reported fatigue (p=0.736) between techniques. No catheter dislodgement events occurred.ConclusionsThe disconnect-reconnect technique allowed for the fastest rate of fluid administration, suggesting that use of this technique may be preferable in situations requiring rapid resuscitation. These findings may help to inform future iterations of paediatric resuscitation guidelines.Trial registration numberThis trial was registered at ClinicalTrials.gov [NCT01774214] prior to enrolling the first participant.

Project description:Animals born with physical impairments may particularly require behavioural flexibility and innovation to survive and carry out social activities, such as grooming. Studies on free-ranging Japanese macaques on Awaji Island, Japan, have shown that individuals with congenital limb malformations exhibited compensatory behaviours while grooming, such as increased mouth and elbow use for removing ectoparasites. The aim of this study is to explore disabled and nondisabled grooming techniques to determine whether and to what extent disabled monkeys develop novel grooming techniques, and if there is disability-associated variation in grooming efficiency. We hypothesized that modified grooming techniques used by disabled monkeys fulfilled the social and relaxing functions of grooming, however, that grooming by manually impaired individuals may still carry a hygienic cost to the recipients. Grooming behavioural data were collected by video in 2007 on 27 adult females (11 with CLMs). With a detailed grooming-related ethogram, we transcribed 216 2-minute continuous grooming video samples. We analyzed the data using generalized linear mixed effects models in R. We found that monkeys with manual impairment were less efficient groomers, as measured by removal and movement efficiency during grooming. However, there were no significant differences associated with the number of grooming movements per sample among the focal animals. Additionally, with a behavioural sequential analysis, we isolated 8 distinct grooming techniques and 3 novel disability-specific movements. Our results indicate that innovation and modification of movement types does not entirely compensate for manual disability, and that manual impairment carries a cost to the hygienic function of grooming. However, for the grooming recipient, the experience of being groomed by a disabled or nondisabled groomer is likely similar, and through movement compensation, disabled monkeys are able to engage in the social aspect of grooming without incurring any disability-associated costs.

Project description:Goal-directed therapy guidelines for pediatric septic shock resuscitation recommend fluid delivery at speeds in excess of that possible through use of regular fluid infusion pumps. In our experience, syringes are commonly used by health care providers (HCPs) to achieve rapid fluid resuscitation in a pediatric fluid resuscitation scenario. At present, it is unclear which syringe size health care providers should use when performing fluid resuscitation to achieve maximal fluid resuscitation efficiency. The objective of this study was therefore to determine if an optimal syringe size exists for conducting manual pediatric fluid resuscitation.This 48-participant parallel group randomized controlled trial included 4 study arms (10, 20, 30, 60 mL syringe size groups). Eligible participants were HCPs from McMaster Children's Hospital, Hamilton, Canada blinded to the purpose of the trial. Consenting participants were randomized using a third party technique. Following a standardization procedure, participants administered 900 mL (60 mL/kg) of isotonic saline to a simulated 15 kg child using prefilled provided syringes of the allocated size in rapid sequence. Primary outcome was total time to administer the 900 mL and this data was collected through video review by two blinded outcome assessors. Sample size was predetermined based upon a primary outcome analysis using one-way ANOVA.12 participants were randomized to each group (n=48) and all completed trial protocol to analysis. Analysis was conducted according to intention to treat principles. A significant difference in fluid resuscitation time (in seconds) was found between syringe size group means: 10 mL, 563s [95% CI 521; 606]; 20 mL, 506s [95% CI 64; 548]; 30 mL, 454s [95% CI 412; 596]; 60 mL, 455s [95% CI 413; 497] (p<0.001).The syringe size used when performing manual pediatric fluid resuscitation has a significant impact on fluid resuscitation speed, in a setting where fluid filled syringes are continuously available. Greatest efficiency was achieved with 30 or 60 mL syringes.ClinicalTrials.gov, NCT01494116.

Project description:BackgroundGuidelines recommend an initial intravenous (IV) fluid bolus of 30 ml/kg isotonic crystalloid for patients with sepsis and hypotension. However, there is a lack of evidence from clinical trials to support this. Accumulating observational data suggest harm associated with the injudicious use of fluids in sepsis. There is currently equipoise regarding liberal or restricted fluid-volume resuscitation as first-line treatment for sepsis-related hypotension. A randomised trial comparing these two approaches is, therefore, justified.Methods/designThe REstricted Fluid REsuscitation in Sepsis-associated Hypotension trial (REFRESH) is a multicentre, open-label, randomised, phase II clinical feasibility trial. Participants will be patients presenting to the emergency departments of Australian metropolitan hospitals with suspected sepsis and a systolic blood pressure of?<?100 mmHg, persisting after a 1000-ml fluid bolus with isotonic crystalloid. Participants will be randomised to either a second 1000-ml fluid bolus (standard care) or maintenance rate fluid only, with the early commencement of a vasopressor infusion to maintain a mean arterial pressure of?>?65 mmHg, if required (restricted fluid). All will receive further protocolised fluid boluses (500 ml or 250 ml, respectively), if required during the 6-h study period. The primary outcome measure is total volume administered in the first 6 h. Secondary outcomes include fluid volume at 24 h, organ support 'free days' to day 28, 90-day mortality, and a range of feasibility and process-of-care measures. Participants will also undergo serial measurement, over the first 24 h, of biomarkers of inflammation, endothelial cell activation and glycocalyx degradation for comparison between the groups.DiscussionThis is the first randomised trial examining fluid volume for initial resuscitation in septic shock in an industrialised country. A pragmatic, open-label design will establish the feasibility of undertaking a large, international, multicentre trial with sufficient power to assess clinical outcomes. The embedded biomarker study aims to provide mechanistic plausibility for a larger trial by defining the effects of fluid volume on markers of systemic inflammation and the vascular endothelium.Trial registrationAustralia and New Zealand Clinical Trials Registry, ID: ACTRN12616000006448. Registered on 12 January 2016.

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Study protocol for a randomised controlled trial comparing the efficiency of two provider-endorsed manual paediatric fluid resuscitation techniques.

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Study protocol for a randomised controlled trial comparing the efficiency of two provider-endorsed manual paediatric fluid resuscitation techniques.

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