Pathogen Transmission, VerticalDCCNCT05326945
Use of Disposable Cuff Cover to Prevent Carriage of Pathogen Microorganisms Originated by Cuffs
A study testing Presence or Absence of a Blood Pressure Cuff Sheath in people with Pathogen Transmission, Vertical and Nosocomial Infection, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pathogen Transmission, Vertical, Nosocomial Infection, Cross Infection
- What is being tested?
- Presence or Absence of a Blood Pressure Cuff Sheath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Apr 2022to 28 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziantep University Şahinbey Research and Application Hospital
Gaziantep, Şahinbey, 27027
Kadiriye Pehlivan, RN, MSc, 05543794829, kadriye.pehlivan@hku.edu.tr
Aynur Koyuncu, RN, PhD Assist Prof, 05398555092, aynur.koyuncu@hku.edu.tr
About this study
Official title: 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.
Read more
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.
- Being tested
- Presence or Absence of a Blood Pressure Cuff Sheath
- Keywords
- Infection, Nursing, Colonization, Sphygmomanometer Cuff, Pathogen Microorganism
- Medical subject headings
- Cross Infection, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Presence or Absence of a Blood Pressure Cuff SheathOther
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
| Study group | Role | What they receive |
|---|---|---|
| Measurement without sheath | No intervention | 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. |
| Sheathed Measurement | Experimental | 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. Receives: Other: Presence or Absence of a Blood Pressure Cuff Sheath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathogenic microorganism
The number of pathogenic microorganism colonies for each sample
Measured: 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 outcomes (1)
Pathogenic microorganism
presence and absence of pathogenic microorganisms
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start28 Apr 2022
- Primary completion28 Oct 2022 (estimated)
- Study completion28 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pathogen Transmission, VerticalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- an experimental clinical study
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aynur KOYUNCU, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326945
- Sponsor's protocol ID
- HasanKUU
- Acronym
- DCC
- Status last verified
- Aug 2022
- First submitted
- 30 Mar 2022
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. Available from http://www.ncbi.nlm.nih.gov/books/NBK115271/
PubMed 23285500Nguyen 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.
PubMed 31862167Suetens C, Latour K, Karki T, Ricchizzi E, Kinross P, Moro ML, Jans B, Hopkins S, Hansen S, Lyytikainen O, Reilly J, Deptula A, Zingg W, Plachouras D, Monnet DL; Healthcare-Associated Infections Prevalence Study Group. Prevalence of healthcare-associated infections, estimated incidence and composite antimicrobial resistance index in acute care hospitals and long-term care facilities: results from two European point prevalence surveys, 2016 to 2017. Euro Surveill. 2018 Nov;23(46):1800516. doi: 10.2807/1560-7917.ES.2018.23.46.1800516.
PubMed 30458912
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Disposable Sleeve Sheath to Prevent Pathogen Microorganisms Transport From Blood Pressure Cuff
- ClinicalTrials.gov ID
- NCT05326945
- Acronym / sponsor ID
- DCC / HasanKUU
- Keywords
- Infection, Nursing, Colonization, Sphygmomanometer Cuff, Pathogen Microorganism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 28 Oct 2022 (estimated)
- Study completion
- 28 Nov 2022 (estimated)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- an experimental clinical study
| Arm | Type | Receives |
|---|---|---|
| Measurement without sheath | No intervention | –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. |
| Sheathed Measurement | Experimental | Other: Presence or Absence of a Blood Pressure Cuff SheathSample 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Presence or Absence of a Blood Pressure Cuff SheathMonitoring 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 | Other | Sheathed Measurement |
Primary outcome
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
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Results publication: PubMed 23285500National 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. Available from http://www.ncbi.nlm.nih.gov/books/NBK115271/
- Results publication: PubMed 31862167Nguyen 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.
- Results publication: PubMed 30458912Suetens C, Latour K, Karki T, Ricchizzi E, Kinross P, Moro ML, Jans B, Hopkins S, Hansen S, Lyytikainen O, Reilly J, Deptula A, Zingg W, Plachouras D, Monnet DL; Healthcare-Associated Infections Prevalence Study Group. Prevalence of healthcare-associated infections, estimated incidence and composite antimicrobial resistance index in acute care hospitals and long-term care facilities: results from two European point prevalence surveys, 2016 to 2017. Euro Surveill. 2018 Nov;23(46):1800516. doi: 10.2807/1560-7917.ES.2018.23.46.1800516.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Presence or Absence of a Blood Pressure Cuff Sheath in people with Pathogen Transmission, Vertical and Nosocomial Infection, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kadiriye Pehlivan, RN, MSc (05543794829, kadriye.pehlivan@hku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05326945, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.