Efficacy of securing urinary catheter in the reduction of urinary tract infections in the critical patients
| ISRCTN | ISRCTN11342326 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11342326 |
| Secondary identifying numbers | BSI2018-19.01 |
- Submission date
- 02/11/2023
- Registration date
- 06/11/2023
- Last edited
- 06/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Clinical guidelines for preventing urinary tract infections related to catheters suggest securing urinary catheters for critically ill patients, even though there is limited research on how well this works. This study's goal is to investigate if properly securing a urinary catheter can lower the chances of getting a urinary tract infection from the catheter and prevent any injuries around the urinary meatus in patients in the intensive care unit.
Who can participate?
Patients aged 18 years and above who are admitted to the Intensive Care Unit (ICU) and are expected to need a urinary catheter for more than 48 hours during their stay in the ICU. The catheter should be put in either in the ICU or the operating room, and the patient must have given their informed consent by signing a document.
What does the study involve?
In the intervention group, the urinary catheter is secured to the thigh using an in-house device, it means that H-shaped pieces of tape must be cuted. A team of 6 nurses are needed so as to control involved patients.
What are the possible benefits and risks of participating?
Patients in the intervention group may experience some discomfort related to the adhesive.
Where is the study run from?
Universitat Internacional de Catalunya (Spain)
When is the study starting and how long is it expected to run for?
July 2017 to June 2021
Who is funding the study?
This study was granted by the Sociedad Española de Enfermería Intensiva y Unidades Coronarias (Spain)
Who is the contact?
Neus Calpe Damians, neuscalpe@uic.es
Contact information
Public, Scientific, Principal Investigator
C/ de Josep Trueta
Sant Cugat del Vallès
Barcelona
08195
Spain
 ORCID ID |
0000-0003-2709-9322 |
|---|---|
| Phone | +34 935 04 20 00 |
| neuscalpe@uic.es |
Study information
| Study design | Multicenter interventional non blinded randomized clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention, Safety, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Effectiveness and safety profile of a simple catheter securement device aimed at preventing catheter-associated urinary tract infection in intensive care unit patients |
| Study objectives | Securing urinary catheter to the thigh decreases the incidence of catheter-associated urinary tact infection, as well as injuries to the meatus. |
| Ethics approval(s) |
1. Approved 06/02/2018, Ethical Committee of the Universitat Internacional de Catalunya (C/ de Josep Trueta, Sant Cugat del Vallès, 08195, Spain; +34 935 04 20 00; nnogales@uic.es), ref: INF-218-01 2. Approved 04/07/2017, Ethical Committee of the Hospital Universitari General de Catalunya. (C/Pere i Pons, 1, Sant Cugat del Vallès, 08195, Spain; +34 935656000; mgranados@quironsalud.es), ref: 2017/03-INF-HUGC |
| Health condition(s) or problem(s) studied | Catheter Associated Urinary Tract Infetion (CAUTI) Meatal Pressure Injuries |
| Intervention | Patients in the Control Group received care as usual, which included non-securement of the urinary catheter. In the Intervention Group, the urinary catheter was secured to the thigh using a simple in-house adhesive device made with a piece of adhesive tape cut in the form of an H, adapted for female and male patients, enabling the catheter to be secured without it resting directly against the skin, that was piloted as part of the present study. Alcohol-free barrier film spray was applied to prevent Medical Adhesive Related Skin Injuries, as described above. The exact site of securement was determined with the patient's leg bent, leaving sufficient slack to avoid traction with posterior movements. The date of securement was written manually on the device, which was replaced every 72 hours, or sooner if necessary. The patient’s participation in the trial ended when one or more of the following circumstances happened: after 30 days of catheterisation, if a CAUTI was diagnosed, 48 hours after catheter removal, 48 hours after ICU discharge or in the event of death. Patients were included using non-probability consecutive sampling and were randomised 1:1 to either the Intervention Group or Control Group using the RANDOMIZER® online tool. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Urinary catheter securement device |
| Primary outcome measure | Catheter-associated Urinary Tract Infection measured every 12 hours. A urinary Tract Infection was diagnosed according to the criteria of the European Centre for Disease Prevention and Control, namely at least one of the following symptoms with no other recognised cause: fever (> 38 °C), urgency, frequency, dysuria or suprapubic tenderness – and a positive urine culture, i.e. ≥ 105 microorganisms per ml of urine with no more than two species of microorganisms. Data from this variable were collected reviewing patient notes. |
| Secondary outcome measures | Meatal pressure injury categorized according to the 1–4 grade classification system of the EPUAP–European Pressure Ulcer Advisory Panel. Data from this variable were collected by direct observation every 12 hours. |
| Overall study start date | 01/07/2017 |
| Completion date | 01/06/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 598 |
| Total final enrolment | 350 |
| Key inclusion criteria | 1. Age >18 years 2. Expected duration of the urinary catheter and length of stay in the intensive care unit >48 hours 3. Urinary catheter inserted in the intensive care unit or in the operating room 4. Signed informed consent |
| Key exclusion criteria | 1. Securing not possible 2. Urinary infection or suspicion on admission 3. Allergy to adhesive tape 4. Urinary or prostatic pathology |
| Date of first enrolment | 01/09/2017 |
| Date of final enrolment | 20/02/2020 |
Locations
Countries of recruitment
- Spain
Study participating centres
Sant Cugat del Vallès
08195
Spain
Barcelona
08003
Spain
Sponsor information
University/education
C/ de Josep Trueta
Sant Cugat del Vallès
Barcelona
08195
Spain
| Phone | +34 935 04 20 00 |
|---|---|
| mllaurado@uic.es | |
| Website | https://www.uic.es |
"ROR" |
https://ror.org/00tse2b39 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 01/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the study will be avaliable upon request from Neus Calpe (neuscalpe@uic.es) |
Editorial Notes
06/11/2023: Trial's existence confirmed by Ethical Committee of the Universitat Internacional de Catalunya.
