RCT To Investigate The Effect Of Using Skin Glue Adhesives And Standard Catheter Care In Minimizing The Peripheral Intravenous Catheter’s Failure Essay.

Discuss about the RCT To Investigate The Effect Of Using Skin Glue Adhesives And Standard Catheter Care In Minimizing The Peripheral Intravenous Catheter’s Failure.

The essence of critiquing lies in the balanced evaluation of the research-study that requires a degree of logic as well as objectivity in the identification of the systematic enquiry that underpins the study (Polit, 2016). Nurses should contemplate and evaluate research-studies to determine its applicability in nursing practice. Varied critiquing models can be used to appraise a quantitative study as CASP (Critical-appraisal skilled program), Polit-tools and CONSORT (University of South America, n. d.). CONSORT guidelines (Consolidated Standards of reporting trials) are used to report informations about quantitative study (clinical trial) that includes checklist as well as flow-chart for tracking samples through a trial.    

Annals are an international journal authorized by the Emergency physicians of American college that functions to promote emergency services by publishing high quality-evidences. The impact factor of 5.008, Cited-Score of 1.81, impact factor- 5 years score of 5.041 and SCImago’s journal rank of 1.942 with credit of most frequently cited journal; determines that Annals is a highly regarded journal (ACEP, 2016). This journal was published in United States. Most of the articles that are accessed via Science-Direct are downloadable in countries other than US too. They got submissions from over 65 countries with 46% outside America and 24% outside Northern-America & West-Europe (Callaham, 2017). These informations assure me to utilize these study-findings in my patient care.

The authors of this study: Bugden, Shean, Scott, Clark as well as Johnstone are the experts in the emergency department of Caboolture Hospital and author Mahila is from the health economics centre of Institute of Menzies, Griffith-University. Bugden, Fraser & Rickard are also experienced in the NHMRC Research Centre with nursing excellence and were the members of Critical-care research group, Queensland University. They conducted this study in the Caboolture’s hospital of Queensland. The above author’s information motivates me to use the findings in clinical area, particularly in ED settings to minimize the failure of PIVCs.

The title of a good journal article should not be long or complicated and should reflect the study’s need as much as possible. A study-title should not validate or invalidate a study (Boswell, n. d.). The researchers have given a clear and concise title as ‘Skin Glue securement reduces the failure of ED-inserted PIVC: A RCT-trial’ that is congruent with the text. They have given an achievable objective as ‘to analyze the effectiveness of using skin glue adhesives plus standard securement in controlling the failure of emergency department (ED) inserted peripheral Intra-venous catheter (PIVC)’.

Research Design

According to Polit (2016), an abstract should inculcate the main points of the study and provide a valuable insight into the complexity as well as basic nature of the study. The abstract’s components include study objectives, methods, results and conclusions. The literature review studies are current, relevant and highly-comprehensive (Gerrish, 2015). Their literature-review related to statistics of PIVC insertion (including ED), percentage of device failures, causes of PIVC-failure, effect of skin-glue in controlling central venous, epidural, with peripheral-arterial catheters and a pilot-study to show the effect of skin glue in ward settings, are well structured and organized.

Bugden (2016) has selected RCT under quantitative design which is a true experimental study-design that has significant features of manipulation (Skin=Glue securement plus Standard-securement), controls (receiving Standard securement) with randomization (assigning samples randomly). Quantitative study is a formal and systematic process that is used to describe variables, draw relationship between variables, obtain information as well as investigate cause & effect interactions (Polit, 2016). They provide sound knowledge-base to guide  nursing-practice than qualitative-designs. The study’s research question as ‘Does the application of skin glue adhesives to adhere the PIVCs improves PIVC failure rate than regular securement?’, is researchable.   

PIVCs are highly inserted in the patients admitted in the hospital with majority being done in emergencies, among which most of them fails because of infections, catheter-occlusions or other causes (Limm, 2013), According to Marsh (2015a), inadequate PIVC fixations are one of the major contributing factor for PIVC-failure. Additionally, lack of best PIVC-securement necessities a novel method to enhance the PIVC fixations, which has motivated them to employ this study.

They have stated a clear, concise and adequate hypothesis that follows logically from the study-problem as ‘the usage of skin glue adhesives will reduce the PIVC’s failure rate: at 48 hours’, as given by Gerrish (2015). They have given scientific hypothesis to predict the relationship between Skin-Glue application and failure of PIVC. They have investigated the failure-rate of PIVC by using one-site, two-armed RCT to select 360 patients with 380 PIVC-insertions and were randomized by a Randomizer-software (without blocking/stratifying), to both the interventional (Skin Glue securement plus standard securement) as well as control groups (standard securement) in a ratio of 1:1. In interventional patients, cyanoacrylate (skin glue) was used to enable adherence of PIVC in the patient’s skin with standard securement as given in the guidelines of Queensland (2015).

According to LoBiondo-Wood (2014), target population is an entire set of population the researcher is interested to study. The researchers are interested in the ED admitted adults at Caboolture’s Hospital, Queensland being inserted with PIVCs. The setting is any physical locations with conditions in which the data is collected (Grove, 2015). They have collected data in the Caboolture’s Hospital which is a Community hospital, situated at 50km from Northern-Brisbane receiving 52,000 presentations/ year. Fink (2013) stated that the samples are the representatives of the entire population.

The Sample

In this study, the samples were recruited by three ED-nurses for a week (16 hrs/ day). The patient’s characteristic that the population should posses in a study is termed as inclusion criteria while those characteristics that should not be possessed is called as exclusion criteria (Gerrish, 2015). They have clearly selected the samples within their eligibility criteria. They used random-sampling to allocate 174 patients with PIVCs to control and interventional group in which all the people has an equal chance to be selected, as advised by Polit (2016).

Ethics are the set of standards that governs the extent to which the research procedures follow the legal, moral, societal and/or professional obligations in their participants (Polit, 2016). They got written-informed consent from the study-participants which is a legal duty of the nurses (CHFA, 2013). They got clearance from the human research ethical committee of Caboolture’s Hospital and was registered ahead in the registry for clinical-trial of Australia and New Zealand.  

According to Polit (2016), data collection is a process by which data is collected to solve the research problem. They have gathered the baseline (demographic) with clinical (confounder) details at patient’s enrollment through self-structured questionnaire with characteristics as age, sex, drug history, PIVC characteristics and duration from insertion to experiment and follow-up. They have investigated the primary outcome by assessing the PIVC’s failure in 48 hours, irrespective of cause by directly-visualizing (in-patients) and/or telephone conversations (out-patients) (Rickard, 2012). They assessed the secondary outcome of analyzing the individual-aspects of PIVC-failure as infection, catheter-occlusion, phlebitis or line-dislodgement by directly-observing, chart-reviewing and collecting data by structured-questionnaire. One in three research nurses in ED have collected data by using above means.

 They have described about the study variables yet their method of measuring was not clearly mentioned. The text suggests that they have measured variable (occlusion) but their means of measuring (scoring/rating scale) is absent. Though their measurement instrument’s reference was mentioned, its origin, validity of self- structured-questionnaire and reliability were not mentioned, which questions the usability of the findings (Rickard, 2012)       

Bias is any form of influence which can distorts the findings of a study (LoBiondo-Wood, 2014). Blinding/stratifying is a process of preventing the participants from contacting the informations about the participants, experimental-details and investigators; that may cause bias (Polit, 2016). They haven’t blinded/masked the study-participants due to the experiment’s nature with similar Skin-Glue’s color and appearance which are exhibited at the interventional-time and follow-up. They haven’t masked ED-nurses as they have to allocate participants to treatment-group and should also determine the intervention’s integrity. But, they have controlled bias through random-assignment of samples, which can enhance the probability of equal dispersion of the samples to the interventional and control group with varied levels of extraneous variables (Polit, 2016).

Data Collection

Quantitative-analysis involves the manipulation of the numerical data by adapting statistical measures with the aim of describing a phenomena or evaluating the magnitude and/or reliability of the relationships between them (Polit, 2016). They have scrutinized the collected data based on their objectives and tested their scientific hypothesis. They determined the sample size of 174 in each group by hypothesizing rates with 11% & 4% PIVC failure in both groups, with 80% power (a=0.05).

They used descriptive measures (mean and percentages) to describe as well as summarize the collected data and inferential measures (p-value and point- estimation- confidence interval) to draw inferences on whether the result found in a participant are likely to exhibit in a large population-group (Newcombe, 2012). They have drawn absolute difference between outcome rates at confidence intervals (95%) and the significance (statistical) was kept at p<0.05. They have efficiently managed the follow up sample loss (0.83%) by excluding them from data analysis to eliminate bias. In-case of multiple devices, they carried-out per-patient analysis by considering the patient’s first PIVC.

Findings are the result of the data-analysis while results are the answers to the research-questions (Polit, 2016). In the data analysis of primary outcomes, the PIVC’s failure rate was found to be reduced (10%) in interventional (17%) than that of control (27%) group indicating a significant difference (CI-95% –18% to –2%) at p=0.02, (which is less than p<0.05). Therefore, the given hypothesis was partially accepted.

In-regard to the secondary statistical analysis, the catheter’s dislodgement was (7%) reduced in interventional (7%) than control (14%) group (CI-95%:–13% to 0%) at p=0.04, less than p<0.05 and so the stated hypothesis was partially accepted. In-contrast, the limb-phlebitis rate (CI-95%:–5% to 3%) as well as catheter-occlusions (CI-95%:–8% to 4%) was analyzed to be decreased in skin glue adhesive than regular (standard) group but the difference wasn’t significant whereas site-infection was absent in both the groups, hence hypothesis was partially rejected. Bugden (2016) has not given suggestions to others for conducting future studies. Their text suggests that they are interested in conducting cost- benefit study. They suggested ED-nurses to secure PIVC line with skin glue adhesive to minimize the failure of PIVCs.  

Conclusion

The conclusion of a study should include the major study-findings by relating with the objectives and hypothesis (LoBiondo-Wood, 2014). Bugden (2016) has concluded that usage of skin glue adhesives plus regular (standard) securement will enhance the adherence of PIVC with patient’s skin, thus reducing PIVC failure rate. They have also suggested that, this study is the first known RCT study which was proposed to find-out the usage of skin glue adhesives plus regular care in minimizing premature fixations in emergency department patients. Marsh (2015b) has also supported that at-least 28% of patients with standard securement showed early PIVC failure. This reduction in PIVC-failure can reduce the money, material and effort.

In the worldwide, staff-nurses has to work for “developing solutions as well as outcomes for patient-care; that can represent the highest available evidence to continuously promote and validate the nursing care (Douglas, 2012). Moreover, the nurses who are the frontline care takers should render a quality care to all the patients in varied settings. All the nurses should conduct researches and develop best possible evidences in-order to promote evidence based nursing-care to the patients (Boswell, n. d.). The nurses should function to prevent illness, protect health and promote health. As nurses are the primary care-taker in the hospital emergencies, they should be expertise in varied care modalities as caring PIVC and protecting PIVCs from premature failure as well as catheter-dislodgement, line-infection and catheter-occlusions (Rebelem, 2016).

Majority of the ED patients are inserted with peripheral IV catheters to begin infusions as well as medicines in-order to protect the patient’s life, in which 33% to 69% of those IV devices prematurely fail leading to discomfort in the patients (Marsh, 2015a). The major contributing factors for this premature PIVC-failure is the inadequate PIVC’s fixation in the patient’s limb causing catheter-dislodgement along with micro-motion leading to vein irritation resulting in vein-phlebitis & catheter-occlusions leading to micro organism entry from the patient’s skin into the PIVC line resulting in severe form of infection (Marsh, 2015b). This type of PIVC failure is found to mostly occur after 48 hrs of PIVC insertion which suggests that enhancement in the securement has to be made in this time-frame (Limm, 2013). Therefore, staff-nurses should adhere the PIVCs with certain adhesives particularly cyanoacrylate glue to prevent premature failure. The staff-nurses should propose further studies to show the effect of skin glue in a large population-group to generalize the findings.

PIVC failure can disrupt the therapies given to the patients as antibiotic, hydration and analgesic therapies that deteriorates patient’s health as well as interrupts the management process. This can burden the patients and care givers indirectly by inducing anxiety, discomfort and increasing the cost of being reinserted with PIVC again (Aymes, 2016). Therefore, nurses should improve their expertise in securing the PIVCs safely in-order to protect the values of patient and their life (ACSQHC, 2012).

Moreover, PIVC-failure can increase the healthcare cost, staff’s time, consumables, extended inpatient-stay with adverse event’s managements. At-least, a little reduction in PIVC-failure can transform into a larger improvement in emergency-admitted patient care, healthcare outcomes with free-flow of healthcare & management costs (HospiMedica, 2016). Hence, by adapting skin glue securement in PIVC patients, the staff-nurses can improve patient values, minimizes healthcare cost and prevent subsequent patient’s morbidity or mortality (Stuart, 2013).

References

ACSQHC- Australian Commission on Safety and Quality in Health Care. (2012). Safety and Quality Improvement Guide Standard 1: Governance for Safety and Quality in Health Service Organization. Sydney: Commonwealth of Australia

Aymes, S. (2016). Skin Glue Reduces IV Failure Rate in the Emergency Department. Retrieved from https://www.acepnow.com/skin-glue-reduces-iv-failure-rate-in-the-emergency-department/

Boswell, C. (n. d.). Chapter-14: The research critique process and the evidence based appraisal process. Retrieved from https://samples.jbpub.com/9781284079654/9781284108958_CH14_Pass03.pdf

Bugden, S., Shean, K., Scott, M., Mihala, G., Clark, S., Johnstone, C., … Rickard, C. (2016). Skin glue reduces the failure rate of emergency department-inserted peripheral intravenous catheters: A randomized controlled trial. Annals of Emergency Medicine, 68, 196–201.https://dx.doi.org/10.1016/j.annemergmed.2015.11.026

CHFA- Consumers Health Forum of Australia. (2013). Informed Consent in Healthcare: An Issues Paper. Retrieved from https://www.chf.org.au/pdfs/chf/Informed-Consent-Issues-Paper.pdf

Douglas, C. (2012). Potter and Perry’s Fundamentals of Nursing- Australian version. (4^th edition). Elsevier: St. Louis, Missouri

Fink, A. (2013). Conducting Research Literature Reviews: From the Internet to Paper. Retrieved from https://books.google.co.in/books?isbn=1483301036

Gerrish, K., & Lathlean, J. (2015). The research process in nursing (7th ed.). Malden, MA: John Wiley & Sons.

Grove, S. K., Grey, J. R., & Burns, N. (2015). Understanding nursing research: Building an evidence-based practice (6th ed.). London, United Kingdom: Elsevier

HospiMedica. (2016). IV Drip Failure Reduced by Skin Glue Application. Retrieved from https://www.hospimedica.com/critical-care/articles/294767305/iv-drip-failure-reduced-by-skin-glue-application.html

Iverson, K.M. (2014). Women veterans’ preferences for intimate partner violence screening and response procedures within the Veterans Health Administration. Research in Nursing and Health, 37, 302-311

Limm, E. (2013). Half of all peripheral intravenous lines in an Australian tertiary emergency department are unused: pain with no gain?. Ann Emerg Med, 62, 521-525.

LoBiondo-Wood, G & Haber, J. (2014). Nursing Research: Methods and Critical Appraisal for Evidence-Based. Retrieved from https://books.google.co.in/books?isbn=0323100864

Marsh, N et al. (2015a). Devices and dressings to secure peripheral venous catheters to prevent complications [review]: Cochrane Database Syst Rev. 6:CD011070.

Marsh, N et al. (2015b). Securement methods for peripheral venous catheters to prevent failure: a randomized controlled pilot trial: J Vasc Access.16:237-244.

Newcombe, R.G. (2012). Confidence Intervals for Proportions and Related Measures of Effect Size. Retrieved from https://books.google.co.in/books?isbn=1439812780

Polit, D.F & Beck, C.T. (2016). Nursing Research: Generating and assessing evidence for nursing practice. Lippincott Williams & Wilkins: New Delhi.

Queensland Government Department of Health. (2015). Centre for Healthcare Related Infection Surveillance and Prevention, Queensland Government Department of Health, Australia: Peripheral intravenous catheter (PIVC) guideline.

Retrieved from https://www.health.qld.gov.au/publications/clinical-practice/guidelines-procedures/diseases-infection/governance/icare-pivc-guideline.pdf.

Rickard, C.M. (2012). Routine versus clinically indicated replacement of peripheral intravenous catheters: a randomized controlled equivalence trial. Lancet, 380, 1066-1074

Stuart, R.L. (2013). Peripheral intravenous catheter–associated Staphylococcus aureus bacteraemia: more than 5 years of prospective data from two tertiary health services. Med J Aust, 198, 551-553.