Use of Disposable Cuff Cover to Prevent Carriage of Pathogen Microorganisms Originated by Cuffs

Nosocomial Infection Clinical Trial

— DCC  

Official title:

Use of Disposable Sleeve Sheath to Prevent Pathogen Microorganisms Transport From Blood Pressure Cuff

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05326945
• Other study ID #: HasanKUU
• Status: Recruiting
• Phase: N/A
• Start date: April 28, 2022
• Est. completion date: November 28, 2022

Study information

• Verified date: August 2022
• Source: Hasan Kalyoncu University
• Contact: Kadiriye Pehlivan, RN, MSc
• Phone: 05543794829
• Email: kadriye.pehlivan[@]hku.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Introduction: Pathogen Microrganisms (PM) colonized on the Blood Pressure Cuff (BPC) are transported from one patient to another by health professionals, which is leading an increase in Health Care Associated Infections (HCAI). The increase in HCAIs is responsible for the increase in mortality and health expenditures. BPCs cannot be sterilized because they are fixed on blood pressure devices, PMs cannot be completely destroyed by using disinfectant, and disposable BPCs increase health expenditures. A safe and inexpensive method has not yet been found to prevent PMs arising from BPCs that circulate between hospital rooms, moved from patient to patient.

Objective: The aim of this project is to determine the effectiveness of the Disposable Cuff Sleeve (DCS) to be passed over BPCs to prevent the transport of PMs from BPC.

The hypotheses of the study: H1: The use of a DCS is not effective in reducing the transmission of pathogenic microorganisms (number of colonies) originating from the sphygmomanometer cuff to the patient's skin during the arterial blood pressure measurement process.

H2: The use of a disposable cuff cover is effective in reducing the transmission of pathogenic microorganisms (number of colonies) originating from the sphygmomanometer cuff to the patient's skin during the arterial blood pressure measurement process.

Materials and Methods: The study is a clinical study which will be conducted between 28 April- 28 November 2022 in Gaziantep University Hospital. Ethical approval will be obtained before starting the research. The sample of the study will consist of all BPCs (n=100) that are actively used in surgical outpatient clinics, surgical services and surgical intensive care units of Gaziantep Unıversity hospital. Each sphygmomanometer will be used for blood pressure measurement and microorganism determination of a patient. For this purpose, arterial blood pressure (ABP) will be measured from the right and left arm of 116 patients who have been admitted to the outpatient clinics and have accepted to participate in the study. Swabs for a patient's ABP measurement and microorganism determination will take approximately 20-25 minutes. A total of 7 swab cultures will be taken for one sample (one BPC and one patient). Sorting and nomenclature of swab culture will be done as follows:

• Sample A: from the inner part of the BPC in contact with the patient's arm,

• Sample B: upper arm area after wiping with 70% alcohol from upper arm area,

• Sample C: the patient's ABP from the upper arm area after measurement,

• Sample D: After cleaning the inside and outside of BPC with 70% alcohol,

• Sample E: From the inner part of DCS which will contact the patient's arm,

• Sample F: After wiping the upper arm area of the other arm of with 70% alcohol,

• Sample G: will be taken from the upper arm area after the ABP is measured from the other arm.

The swab culture samples taken by the researchers will be delivered to the Microbiology Laboratory of Gaziantep University Hospital within 30 minutes without waiting. The number of PMs and colonies grown in culture samples will be determined according to international standards. The ABP values measured by BPCs (uncoated), DCS' (sheathed) and swab culture results obtained from samples A, B, C, D, E, F, G will be compared statistically. Data analysis will be performed in SPSS 22.0 package program. For statistical significance, p <0.05 will be accepted.

If the H1 hypothesis is confirmed at the end of the study, the use of DSS is proven to be effective in preventing PM transport from BPCs. Prevention of PMs transported from patient to patient with BPCs can lead to a reduction in HCAIs. Reducing HCAIs can reduce mortality and cost increase associated with HCAIs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: November 28, 2022
• Est. primary completion date: October 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Over 18 years old, No fistula, wound or surgical intervention that would prevent blood pressure measurement in both upper arms, Those who have not undergone mastectomy surgery, Not having a diagnosed contagious disease, No tissue ischemia, signs of infection (phlebitis and skin infection), circulation problems, nerve damage, paralysis in the upper arm region, Patients without intravenous or intra-arterial catheters in both arms will be included in the study.

Inclusion Criteria for TAM:

Actively used in surgical outpatient clinics, surgical services, surgical intensive care units for at least one month, Blood pressure devices that measure ABP by wrapping a cuff on the upper arm area, It can be opened completely flat, Sphygmomanometers with the length of the TAM long enough to encircle the upper arm 1.5 times will be included in the research.

Exclusion Criteria:

Patients who want to withdraw from the study at any stage after accepting to participate, TAMs produced for measurement from the lower extremity (leg) or radial artery

Related Conditions & MeSH terms

• Communicable Diseases
• Cross Infection
• Cuff
• Infections
• Nosocomial Infection

Intervention

Other:
• Presence or Absence of a Blood Pressure Cuff Sheath
Monitoring of microorganism transfer from the sphygmomanometer to the patient, from the patient to the sphygmomanometer in case the sheath designed in the research is put on or not before the blood pressure measurement process

Locations

Country	Name	City	State
Turkey	Gaziantep University Sahinbey Research and Application Hospital	Gaziantep	Sahinbey

Sponsors (1)

Lead Sponsor	Collaborator
Hasan Kalyoncu University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

National Clinical Guideline Centre (UK). Infection: Prevention and Control of Healthcare-Associated Infections in Primary and Community Care: Partial Update of NICE Clinical Guideline 2. London: Royal College of Physicians (UK); 2012 Mar. — View Citation

Nguyen LKN, Megiddo I, Howick S. Simulation models for transmission of health care-associated infection: A systematic review. Am J Infect Control. 2020 Jul;48(7):810-821. doi: 10.1016/j.ajic.2019.11.005. Epub 2019 Dec 18. Review. — View Citation

Suetens C, Latour K, Kärki T, Ricchizzi E, Kinross P, Moro ML, Jans B, Hopkins S, Hansen S, Lyytikäinen O, Reilly J, Deptula A, Zingg W, Plachouras D, Monnet DL; The Healthcare-Associated Infections Prevalence Study Group. Prevalence of healthcare-associa — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathogenic microorganism	The number of pathogenic microorganism colonies for each sample	Unsheathed blood pressure measurement (without intervention) and sheath blood pressure measurement (with intervention) will be followed up consecutively for each patient. Laboratory results will be sent after 24 hours.
Secondary	Pathogenic microorganism	presence and absence of pathogenic microorganisms	Unsheathed blood pressure measurement (without intervention) and sheath blood pressure measurement (with intervention) will be followed up consecutively for each patient. Laboratory results will be sent after 24 hours.