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

August 2, 2022 updated by: Aynur KOYUNCU, Hasan Kalyoncu University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Şahinbey
      • Gaziantep, Şahinbey, Turkey, 27027
        • Recruiting
        • Gaziantep University Sahinbey Research and Application Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Measurement without sheath

Sample A: Investigator will take culture from the inside of the BPC, which will contact the patient's right upper arm, wearing sterile gloves, and will remove the gloves.

B:Investigator will wipe the right upper arm area of the patient with (70% alcohol+2% chlorhexidine) solution in accordance after wearing sterile gloves, wait for 30 seconds and after the alcohol dries investigator will take culture from the patient's right upper arm, wearing a new sterile glove.

C:investigator will measure ABP on the right upper arm of the patient with the same sterile glove, and after the measurement, the first investigator will take culture from the patient's right upper arm by wearing a new sterile glove, both researchers will remove the gloves.

D:investigator wore a new sterile glove after ABP measurement and wiped the inside and outside of the BPC with solution, the first investigator would wear a new sterile glove to take culture, both researchers will remove the gloves.
EXPERIMENTAL: Sheathed Measurement

Sample E: DCC sterile package will be opened the investigator will hold the sphygmomanometer, after investigator wears sterile gloves, DCC will put it cuff of the same cuff. Culture will be taken investigator from the inside of the DCC that will contact the patient's left upper arm, before the ABP measurement, the first investigator will remove the gloves.

F:Sterile gloves will be worn by the investigator and the left upper arm area of the patient will be wiped with solution before the ABP measurement wait 30 seconds, and after the solution dries, the first investigator will use a new sterile After wearing gloves, he will take a swab culture from the left upper arm region.

G:The investigator will measure ABP from the patient's left upper arm with the same glove, and after the measurement, the first investigator will take culture from the patient's left upper arm after wearing a new sterile glove.

Culture results taken from the patients will be compared statistically.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathogenic microorganism
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathogenic microorganism
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasan Kalyoncu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 28, 2022

Primary Completion (ANTICIPATED)

October 28, 2022

Study Completion (ANTICIPATED)

November 28, 2022

Study Registration Dates

First Submitted

March 30, 2022

First Submitted That Met QC Criteria

April 6, 2022

First Posted (ACTUAL)

April 14, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HasanKUU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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