Clinical trial NCT04821193: Comparison of the Effects of 5%NaHCO3, 2%CHG and 70%Alcohol in the Prevention of Infections Related to Catheter
Official title: Comparison of the Effects of 5% NaHCO3, 2% Chlorhexidine Gluconate and 70% Alcohol for Prevention of Infections Related to Catheter Applications in Children.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disinfectant Dye Adverse Reaction
Catheter-Related Infections
Nursing Caries
Children, Only
Skin Lesion
Chlorhexidine Adverse Reaction
Catheter
Keywords: Antiseptic
Intravenous catheterization
Catheter-related infection
Chlorhexidine gluconate
Sodium bicarbonate
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 62
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blind Randomized controlled Experimental
Primary purpose: PREVENTION

Brief summary: Intravenous catheters have become one of the indispensable tools of modern medicine. Peripheric intravenous catheters facilitate the work of healthcare professionals in the treatment phase, especially in diagnostic procedures. Intravenous catheters cause microorganisms to enter the bloodstream by damaging the skin, which is the body's first defense barrier. In this case, it causes infections, sepsis, an increase in mortality and morbidity rates, prolongation of hospital stay, increase in antibiotic use, and medical expenses. The density of the skin flora in the area where the catheter will be inserted is a major risk factor for infection.To prevent complications associated with peripheric intravenous catheters; Performing the procedure in line with the principles of surgical asepsis and following the correct follow-up are among the most important measures that the nurse should take. Also, the child and the parents should be prepared for the procedure and the appropriate environment should be provided. Along with correct catheter placement and care, antisepsis of the cannula placement area is among the indicators of nursing care.

As well as the effectiveness and safety of skin disinfectants, topical absorption, lack of toxic effect, local and irritation effect are also important. Solutions with 5% NaHCO3 have recently come to the fore as antiseptic agents. When the literature is examined, it has not been found that there are very few studies on this solution and it is used in skin antisepsis before peripheral intravenous catheterization in children. This study was planned as a randomized controlled experimental design to determine the effectiveness of 5% NaHCO3 water solution in catheter site cleaning in pediatric patients by comparing it with the most commonly used antiseptic agents and to monitor the development of catheter-related infections.

Detailed description: Intravenous therapy is one of the basic elements of modern health care. IV routes provided through catheters for pediatric patients are necessary for primary and secondary health and increase the possibility of mortality and morbidity depending on the treatment given and the factors of the patient. As in every invasive application, there are problems regarding the use of catheters, which is a minimal surgical procedure, and perhaps the most important of these is catheter-related infections.

CRI's are defined as the accompanying of both local (redness around the catheter, increased temperature, discharge, drainage, tenderness, edema) and systemic (fever, chills, changes in laboratory tests) infection findings in patients and is an important complication for children. is happening. The increase in prevalence varies among patients, as well as between cities and countries, and is among the top three among hospital-associated infections.

Although there are many studies on infections related to the use of a peripheric intravenous catheters in adult patients, it is reported that this issue is not addressed much in children. It is thought that there is no standardization regarding peripheric intravenous catheters management in the studies conducted.

Since the risk factors for infection such as body weight, concomitant chronic disease, characteristics of the catheter used and the drug administered, presence of interconnection for pediatric patients are different from adults, catheter-related infections in the pediatric age group requires a separate discussion. It cannot be denied that the main step in the prevention of catheter-related infections is the management of peripheric intravenous catheters and determining an appropriate skin antiseptic is a part of this.

In Children, 70% Alcohol, 2% Chlorhexidine Gluconate, 1% Octenidine, and 10% Povidone-iodine type antiseptics are commonly used for skin antisepsis. Sodium bicarbonate (NaHCO3) solutions are used in different areas such as oral hygiene and dental care in the world and our country, and side effects are not reported. There is limited information in the literature regarding its use as a skin antiseptic, and it is seen that this information belongs to the adult age group. There is no data on the child age group.

In this study, which was planned in two stages to determine the effectiveness of the use of sodium bicarbonate as a skin antiseptic in the prevention of catheter-related infections, the effectiveness of the antiseptics used in the first stage was evaluated in the laboratory environment against the most common microorganisms in the skin flora, and in the second stage, the use of these antiseptic solutions in skin cleansing in pediatric patients before the peripheric intravenous catheters procedure their effectiveness has been evaluated.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 1-18
* Having inpatient treatment in pediatric clinics
* No previous history of catheter-related infections
* No history of systemic infection
* Absence of immunological disease
* Not using antibiotherapy
* No scar/scar tissue on the skin in the catheterization area

Exclusion Criteria:

* Being an inpatient who does not need intravenous treatment
* Finding an infection
* Having a chronic skin disease
* Having a history of allergies
* Being a newborn

Primary outcomes:
measure: The effectiveness of the solutions - In-vitro analysis
timeFrame: One months
Secondary outcomes:
measure: The effectiveness of the solutions - Practice
timeFrame: Five months
Other outcomes:
measure: Efficacy and Safety: Vital signs - Body temperature
timeFrame: Twelve hours, 15 minutes, 2 repeated measurements
measure: Efficacy and Safety: Vital signs- Heart rate
timeFrame: Twelve hours, 15 minutes, 2 repeated measurements
measure: Efficacy and Safety: Vital Signs - Blood pressure
timeFrame: Twelve hours, 15 minutes, 2 repeated measurements
measure: Efficacy and Safety: Vital signs - Oxygen saturation
timeFrame: Twelve hours, 15 minutes, 2 repeated measurements
measure: Efficacy and Safety: Vital signs - Respiratory
timeFrame: Twelve hours, 15 minutes, 2 repeated measurements
measure: Efficacy and Safety: Local infection - Temperature change
timeFrame: Twelve hours, 15 minutes, 2 repeated inspection
measure: Efficacy and Safety: Local infection - Discharge/drainage
timeFrame: Twelve hours, 15 minutes, 2 repeated inspection
measure: Efficacy and Safety: Local infection - Pain
timeFrame: Twelve hours, 15 minutes, 2 repeated inspection
measure: Efficacy and Safety: Local infection - Tenderness
timeFrame: Twelve hours, 15 minutes, 2 repeated inspection
measure: Efficacy and Safety: Local infection - Swelling
timeFrame: Twelve hours, 15 minutes, 2 repeated inspection
measure: Efficacy and Safety: Skin swab effectiveness
timeFrame: 5 months
measure: Efficacy and Safety: Laboratory analysis
timeFrame: 5 months
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpaşa
state: Avcilar
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Aysegul Simsek, PhD
role: STUDY_DIRECTOR
References:
citation: Abolfotouh MA, Salam M, Bani-Mustafa A, White D, Balkhy HH. Prospective study of incidence and predictors of peripheral intravenous catheter-induced complications. Ther Clin Risk Manag. 2014 Dec 8;10:993-1001. doi: 10.2147/TCRM.S74685. eCollection 2014.
citation: Adams D, Elliot TS. Skin antiseptics used prior to intravascular catheter insertion. Br J Nurs. 2007 Mar 8-21;16(5):278-80. doi: 10.12968/bjon.2007.16.5.22997.
citation: Berry AM. A comparison of Listerine(R) and sodium bicarbonate oral cleansing solutions on dental plaque colonisation and incidence of ventilator associated pneumonia in mechanically ventilated patients: a randomised control trial. Intensive Crit Care Nurs. 2013 Oct;29(5):275-81. doi: 10.1016/j.iccn.2013.01.002. Epub 2013 May 19.
citation: Bolton D. Improving peripheral cannulation practice at an NHS Trust. Br J Nurs. 2010 Nov 25-Dec 8;19(21):1346, 1348-50. doi: 10.12968/bjon.2010.19.21.79998.
citation: Letscher-Bru V, Obszynski CM, Samsoen M, Sabou M, Waller J, Candolfi E. Antifungal activity of sodium bicarbonate against fungal agents causing superficial infections. Mycopathologia. 2013 Feb;175(1-2):153-8. doi: 10.1007/s11046-012-9583-2. Epub 2012 Sep 19.
citation: Ding L, Wu HL, Zhu JH, Ding M, Wang YL, Xu XJ. Superiority of 5% NaHCO3 for preoperative hair removal in patients undergoing coronary artery bypass graft surgery with a limb vein: a randomized controlled trialdagger. Eur J Cardiothorac Surg. 2014 Aug;46(2):e28-32. doi: 10.1093/ejcts/ezu203. Epub 2014 Jun 18.
citation: Wu HL, Xu YH, Shi JH. 5% NaHCO3 Is Appropriate for Skin Cleaning With Central Venous Catheters. Am J Med Sci. 2017 Jan;353(1):12-16. doi: 10.1016/j.amjms.2016.10.010. Epub 2016 Oct 29.