Dispositivos Adhesivos Frente a Dispositivos elásticos Para la sujeción de la Sonda Urinaria en el Paciente crítico Estudio Experimental
Dispositivos Adhesivos Frente a Dispositivos elásticos Para la sujeción de la Sonda Urinaria en el Paciente crítico Estudio Experimental
Nowadays there are two types of urinary catheter securement devices, adhesive and elastic bands. The goal of this clinical trial is to determine which type of device-adhesive or elastic-is more effective for securing urinary catheters in critically ill patients. The study also aims to evaluate the prevention of urethral meatus injuries, patient discomfort, and the incidence of catheter-associated urinary tract infections .
The main questions the trial aims to answer are:
Participants will:
Urinary catheters (UC) are commonly used medical devices in Intensive Care Units (ICU), Between 50 % and 80 % of ICU patients have a UC in place. Although this is a relatively simple device, it is not free from risks, and complications associated with its use can be diverse and potentially serious.
Among the most relevant complications are three. First, catheter-associated urethral meatus injuries, which are lesions caused by continuous pressure from the catheter on surrounding tissues, affecting the glans, penis, or labia minora. The prevalence of these injuries in critically ill patients ranges between 13 % and 36 %. Secondly, pain and discomfort, occurring in approximately 47 % of UC users. Thirdly, catheter-associated urinary tract infection (CAUTI) is a frequent complication; in Spanish ICUs, it has accounted for 25 % to 30 % of all device-associated infections in recent years.
Securing urinay catheter to the leg is recommended by several international clinical practice guidelines (CPG) to prevent complications associated with UC use. In Spain, the national ITU ZERO initiative-led by the Ministry of Health and the Spanish Society of Intensive and Coronary Care Nursing-includes catheter securement as part of recommended care to reduce the risk of UC-related UTIs in critically ill patients.
Recent studies have evaluated the effectiveness of thigh securement of UC in ICU patients. One 2024 study showed that secured catheters significantly reduced the incidence of meatal injuries, decreased associated discomfort and lowered the risk of CAUTI.
Nowadays, two main types of commercial catheter securement devices are available: elastic wristband-style devices and adhesive-based devices. However, recent studies have not directly compared the effectiveness of these two types, and expert opinions vary.
Moreover, CPG recommend securement devices but do not specify which method is best for critically ill patients. This lack of clear guidelines and robust scientific evidence has resulted in low adherence to catheter securement practices among nurses. Prevalence studies from Canada and the UK (2016) reported low adherence rates. A recent qualitative study concluded that this low adherence stemmed from lack of training, ambiguous recommendations, limited scientific evidence, and insufficient engagement of nursing staff in care research.
In conclusion, urinary catheter securement in critically ill patients is a fundamental intervention for preventing complications, yet there remains a clear lack of comparative evidence between available devices, limiting professionals' ability to select the safest and most effective option. This knowledge gap justifies the need for research to determine which of the two securement types-adhesive or elastic-is more beneficial in this patient population.
________________________________________ Hypothesis: In critically ill patients, urinary catheter securement using adhesive devices is more effective than elastic wristband-style devices in preventing urethral meatus injuries, reducing discomfort, and decreasing the incidence of catheter-associated urinary tract infections.
It is proposed that adhesive devices provide greater stability and exert less pressure on tissues, thereby reducing iatrogenic complication risk and improving patient well-being, compared with elastic devices that may cause vascular compromise or skin irritation in edematous or fragile-skin patients.
This hypothesis will be tested by comparing both securement methods in terms of incidence of injuries, pain, and urinary tract infections in critically ill patients requiring long-term urinary catheters.
________________________________________ OBJECTIVES
Primary Objective:
To evaluate and compare the effectiveness of adhesive versus elastic wristband securement devices for urinary catheters in preventing catheter-associated complications in critically ill patients.
Secondary Objectives:
METHODOLOGY This study will be conducted in the Intensive Care Unit (ICU) of Hospital de la Santa Creu i Sant Pau. It is an experimental, randomized, open-label trial with two intervention groups. Group 1 (G1) patients will receive urinary catheter securement using a commercially available adhesive device, while Group 2 (G2) patients will use an elastic wristband device. In this study, patients will be randomly assigned to G1 or to G2.
Inclusion Criteria:
Exclusion Criteria:
ncalpe@santpau.cat+34 932 91 90 00
mireia.llaurado@ub.edu+34665033050