Hospital-acquired infections (HAIs) are still one of the most important sources of morbidity, prolonged hospitalization, higher health care costs and mortality in critically ill patients admitted to intensive care unit (ICU). ^1,2   Although much has been done in the areas of ventilator associated pneumonia, catheter associated urinary tract infections and blood stream infections, less effort has been made to address ear related complications in the hospital setting, such as otitis externa and pressure related injury to the ears, which can have a significant impact on patient comfort, recovery and quality of care.³

People who are critically ill in the ICU are especially vulnerable because they are kept immobile for long periods, have compromised immune systems, and are exposed to antibiotics of many types, have excess moisture and are frequently handled during care of the external ear by the attending staff, all of which contribute to their susceptibility.^4,5

Healthcare-associated otitis externa is usually caused by opportunistic microorganisms, particularly Pseudomonas aeruginosa, and Staphylococcus aureus.⁶

Uncontrolled infections can lead to serious complications such as cellulitis, chondritis or malignant otitis externa, especially in those with diabetes or compromised immune systems.⁷

Auricular pressure injuries are localized skin and cartilage injuries caused by continued pressure, friction or shear forces on the outside of the ear.⁸

The use of medical devices in an ICU environment, like oxygen tubing, face masks, endotracheal tube holders, cervical collars and non-invasive ventilation interfaces, have significantly contributed to the occurrence of medical device-related pressure injuries (MDRPIs).⁹

The auricle is particularly susceptible as it is composed of a thin external skin layer overlying cartilage with a very thin layer of subcutaneous tissue, so that it is easily compressed and becomes ischemic. Patients that are sedated or unconscious can't move themself and aren't able to complain of discomfort, which raises the risk of tissue damage.

The recent advances in critical care have increased survival and increased the reliance on invasive monitoring and respiratory support devices in the ICU and increased length of stay. As a result, skin injuries, particularly in the ear, as a result of the use of the device has become a major patient safety problem. The incidence of medical device-associated pressure injury has been reported as a significant portion of hospital-associated pressure injuries, including the head and ear as common sites for pressure injury in patients with respiratory support.¹⁰

These injuries can result in pain, a slower healing process, secondary infection, cosmetic deformity, and extended hospital stays.

Patient and treatment-related factors have been recognized as contributing to the development of hospital acquired otitis externa and auricular pressure injuries. Susceptibility has been linked to advanced age, diabetes mellitus, malnutrition, hypoalbuminemia, immunosuppression, extended mechanical ventilation, vasopressor therapy, edema, excessive sweating, decreased tissue perfusion, and length of stay in the intensive care unit (ICU), among other factors.¹¹

Likewise, the constant pressure from oxygen tubing, endotracheal fixation devices, hearing aids, and monitoring devices can affect local blood flow and cause tissue damage and infection.¹²

Although there has been a rise in the awareness of medical device related complications, there is limited evidence that specifically addresses the co-occurrence of HA and APH in patients, in low and middle-income countries. The majority of published studies have focused on general pressure injuries or ear infections alone and there is a lack of knowledge in the literature about the incidence of pressure injuries, risk factors, and prevention strategies in critically ill patients in the intensive care unit (ICU).¹³

Lack of surveillance data also limits evidence-based recommendations for routine ear assessment and preventive interventions in intensive care settings in Pakistan and other developing health care systems.

The prevention of these complications is possible through the early identification of high-risk patients and the implementation of preventive measures: regular repositioning of medical devices, regular examination of the auricles, and use of protective dressings with silicone or ear hygiene maintenance, moisture control and staff education. Therefore, knowledge of the epidemiology and determinants of these conditions is critical in order to improve patient safety, reduce complications and to optimize nursing care in the ICU.¹⁴

The aim of the present study was to explore the incidence of hospital acquired otitis externa and auricular pressure injuries among patients admitted to the ICU, as well as to characterize clinical, demographical and device related risk factors that may be involved with the development of these pressure injuries. The results will help evidence the necessity of targeting preventive protocols that will minimize ear-related complications and enhance the quality of critical care service.

Study Design and Setting This was a prospective observational study carried out in Intensive Care Unit (ICU) of District Headquarter (DHQ) hospital Abbottabad, Pakistan for a period of six months Ist January to 30th June 2025. The DHQ Hospital has an ICU with full monitoring and supportive care of critically ill medical and surgical cases, but the hospital has no mechanical ventilator facility. The study thus excluded patients with invasive mechanical ventilation, thus limiting the studied population to those treated in the ICU as routine care. Study Population and Sample Size Using the single population proportion formula, the minimum sample size required was 139 participants, based on an expected incidence as determined by previous published literature, a 95% confidence level (Z = 1.96) and a 5% margin of error of 10%.15 A consecutive sampling technique was used to enroll 140 patients to overcome the possible exclusion and incomplete data. Adult patients aged 18 years or older, who were still in the ICU for at least 48 hours, and who did not have any external ear disease (otitis externa, auricular pressure disease, etc.) at admission were included. Ears with previous surgery, incomplete clinical records, and dermatological disorders involving the auricle, congenital ear deformities, and traumatic ear trauma or ear infections were excluded from the study. Data Collection Demographic and clinical data were obtained with the patients' informed consent, which was obtained in writing, for each patient using a structured data collection form. Clinical data recorded were age, sex, primary diagnosis, length of stay in the intensive care unit, diabetes mellitus, hypertension, immunocompromise status, nutritional status, oxygen therapy, and use of nasal cannula or face mask, as well as prolonged immobilization and other clinical data. Baseline examination of both ears was completed at the time of admission to the ICU and periodic ear exams were done every 48 hours until ICU discharge or death. The external auditory canal and auricle was clinically assessed by the attending physician in consultation with an ENT specialist to evaluate for signs of hospital-acquired otitis externa such as erythema, edema, tenderness, otorrhea, and pain on manipulation. Pressure injuries in the auricle were also evaluated using the National Pressure Injury Advisory Panel (NPIAP) Staging System. If any otitis externa or pressure wound of the ears occurred 48 hours or more after admission to the ICU, it was considered as hospital acquired. Study Variables The main outcome measures were hospital-acquired otitis externa and pressure injuries of the ears in the ICU patients. The independent variables were age, gender, ICU length of stay, diabetes mellitus, hypertension, length of oxygen therapy, long-term immobilization, nutritional status, serum albumin level, level of consciousness, frequency of patient repositioning and oxygen delivery devices (nasal cannula, oxygen face mask). Statistical Analysis The data were inputted and analyzed using Statistical Package for the Social Sciences (SPSS) version 26.0. Continuous variables were presented as mean ± standard deviation (SD); categorical variables as frequencies and percentages. Categorical variables were evaluated for association with development of HAEA or HAPIN by Chi-square test and continuous variables were evaluated by independent-samples t-test, as appropriate. The variables that made significant association in the univariate analysis were included in the multivariable logistic regression model to determine independent predictors for ear-related complications. A p value of < 0.05 was set as the criterion for statistical significance. Ethical Considerations Prior to the start of the study, ethical approval was received from the DHQ Hospital Abbottabad's Institutional Ethical Review Committee (IERC). Informed consent written by the participants or their legal guardians was obtained before enrollment.

There were a total of 140 patients in the study who were on the ICUs. The mean age of the participants was 54.8 ± 16.3 years (range: 18–88 years). The largest proportion of patients belonged to the 60–79 years, age group (51, 36.4%), followed by 40–59 years (47, 33.6%), 18–39 years (28, 20.0%), and ≥80 years (14, 10.0%). There were 82 (58.6%) males and 58 (41.4%) females. Diabetes mellitus was present in 46 (32.9%) patients, hypertension in 61 (43.6%), prolonged ICU stay (>5 days) in 55 (39.3%), oxygen therapy via nasal cannula or face mask in 97 (69.3%), prolonged immobilization (>72 hours) in 74 (52.9%), and hypoalbuminemia (<3.5 g/dL) in 42 (30.0%) (Table 1).

Table 1. Baseline Characteristics of ICU Patients (n = 140)

During admission to the ICU, 16 patients (11.4%) were diagnosed with hospital-acquired OTE, and 22 patients (15.7%) with APIs. While 108 patients (77.1%) were without either complication, 6 patients (4.3%) had both complications (Table 2). However, in patients with auricular pressure injuries, the most common pressure injury stage was stage 1 (14/22, 63.6%), stage 2 (7/22, 31.8%), and stage 3 (1/22, 4.5%). No stage 4 pressure injuries were identified (Table 3).

Table 2. Incidence of Hospital-Acquired Otitis Externa and Auricular Pressure Injuries Among ICU Patients (n = 140)

Table 3. Severity Distribution of Auricular Pressure Injuries According to Pressure Injury Stage (n = 22)

Table 4 shows the association of clinical characteristics and hospital-acquired otitis externa. Significantly more patients ≥60 years developed otitis externa than patients younger (75.0% vs. 42.7%, p = 0.018). Diabetes mellitus (62.5% vs. 29.0%, p = 0.009), ICU stay longer than five days (75.0% vs. 34.7%, p = 0.002), oxygen therapy (93.8% vs. 66.1%, p = 0.027), prolonged immobilization (81.3% vs. 49.2%, p = 0.015), and hypoalbuminemia (56.3% vs. 26.6%, p = 0.020) were all significantly associated with the development of hospital-acquired otitis externa. Males were more likely than females to have had otitis externa (68.8% vs. 57.3%, p = 0.391), but this was not a statistically significant finding.

Table 4. Risk Factors Associated with Hospital-Acquired Otitis Externa

Likewise, there were a number of factors associated significantly with auricular pressure injuries (Table 5). Patients older than 60 years had an increased rate of pressure injuries compared to patients younger than 60 years (72.7% vs. 41.5%, respectively, p = 0.010). Diabetes mellitus (54.5% vs. 28.8%, p = 0.024), ICU stay longer than five days (81.8% vs. 31.4%, p < 0.001), oxygen therapy (95.5% vs. 64.4%, p = 0.006), prolonged immobilization (86.4% vs. 46.6%, p = 0.001), and hypoalbuminemia (59.1% vs. 24.6%, p = 0.003) were also significantly associated with auricular pressure injuries. There was no significant difference between male and female with regard to the development of pressure injury (63.6% vs 57.6%, p = 0.612).

Table 5. Risk Factors Associated with Auricular Pressure Injuries

Prolonged stay in the ICU (> 5 days) was the strongest independent predictor of ear related complications (AOR = 3.84; 95% CI: 1.71–8.61; p = 0.001) using the multivariable logistic regression analysis. Other independent predictors included prolonged immobilization (AOR = 3.25, 95% CI: 1.36–7.74, p = 0.008), oxygen therapy (AOR = 2.91, 95% CI: 1.09–7.76, p = 0.033), diabetes mellitus (AOR = 2.68, 95% CI: 1.18–6.09, p = 0.019), and hypoalbuminemia (AOR = 2.47, 95% CI: 1.05–5.82, p = 0.038) (Table 6).

Table 6. Multivariable Logistic Regression Analysis of Independent Predictors

Summary of Findings

The incidence of HAE in the 140 patients in the ICU included in this study was 11.4% and 15.7% for APE, respectively, with 4.3% having both complications. The majority of the pressure injuries on the ear lobe were Stage I (Grade 1), suggesting that most were identified early. In the univariate analysis advanced age, diabetes mellitus, prolonged ICU stay, oxygen therapy, prolonged immobilization, and hypoalbuminemia were significant factors for both complications, while male gender was not. Multivariable logistic regression revealed that ICU stay > 5 days, prolonged immobilization, oxygen therapy, diabetes mellitus, and hypoalbuminemia were the strongest independent risk factors for the development of ear-related complications, suggesting that these are important modifiable risk factors for avoiding ear-related complications in critically ill patients in the ICU.

The present study aimed at finding the prevalence and risk factors for hospital acquired otitis externa and pressure injuries of auricle among the patients who are admitted in the Intensive Care Unit of DHQ Hospital Abbottabad. The results showed that 11.4% of patients went on to have HAE and 15.7% auricular pressure injuries during their time in the ICU. While no mechanical ventilation is available in the DHQ hospital's ICU, ear complications were seen, which suggests that prolonged hospital stay, oxygen via nasal cannula or face mask, immobilization, and underlying health problems were enough to make the critically ill patient at risk for these preventable complications. Our study found the incidence of hospital-acquired otitis externa (Hae) (11.4%) to be similar to that reported by Roland and Stroman (2002) who found long hospital stays, excessive moisture and immunocompromised status to be major risk factors for external ear infections in hospitalized patients.16 Similarly Kaushik et al., (2010) has reported Pseudomonas aeruginosae and Staphylococcus aureus as the major pathogens involved in the occurrence of otitis external in hospitalized patients and also has found that diabetes mellitus and prolonged health care exposure are significant risk factors for the occurrence of otitis external.The strong relationship between diabetes and both longer ICU stay and otitis externa seen in our study is thus in line with the literature.17 According to our study, 15.7% of the patients in the intensive care unit had auricular pressure injury, with 63.6% of the pressure injuries in the intensive care unit being at Stage I. Ear pressure injuries are common and were reported in this study as with Black et al. (2010) due to the constant pressure of oxygen tubing and other clinical devices.18 In the current study, the greatest independent risk factors for otitis externa and auricular pressure injuries were prolonged ICU stay. The rates of complications were significantly higher in patients who were admitted for a greater length of time than 5 days. In line with this observation, Cox and Roche (2015)19 found that there is a connection between attitudes and academic performance,19 Who found that the longer the critical care, the greater the likelihood of developing a pressure injury, due to the continuous pressure and immobility experienced during critical care. Likewise, Aldenden et al., (2017) found that length of ICU stay independently contributes to the development of PIs due to tissue ischemia and inadequate microcirculation.20 Ear complications were also significantly associated with diabetes mellitus, hypoalbuminemia and prolonged immobilization in our study. These results corroborate the findings of Jaul and Calderon-Margalit (2015) showing that poor nutrition status, impaired wound healing, and metabolic disorders significantly contribute to risk for pressure injuries. In addition, diabetic patients are known to have impaired local immunity and decreased tissue perfusion, risk factors for infection and for skin breakdown.21 Our study shows that ear complications can be acquired in the hospital even in a secondary-care ICU without the use of a mechanical ventilator, which is a departure from many studies that have been carried out in tertiary-care ICUs with mechanical ventilators. This discovery expands the existing knowledge of how simple routine oxygen delivery devices, prolonged immobilization and lack of pressure relief alone can be enough to cause significant ear morbidity. Therefore, routine ear checks, repositioning of oxygen tubing, protective silicone ear dressings, skin hygiene and early nursing interventions to prevent these complications should be included in standard care and practice in the ICU. Overall the results of this study are in line with the literature of other countries and it offers evidence specific to the local context in Pakistan. They highlight the importance of establishing guidelines for ear assessment and prevention in ICUs, even in those without high-level ventilator services, in order to keep patients safer and minimize hospital-acquired complications.

The finding of this study is that HAE and APs are clinically important and largely preventable complications in mechanically ventilated patients in critical care units (even in secondary care without mechanical ventilator facilities). The major risk factors associated with these conditions were prolonged stay in the intensive care unit and diabetes mellitus, prolonged immobilization, oxygen administration through nasal cannula or face mask and hypoalbuminemia. The results highlight the need for the inclusion of routine ear assessment, early risk identification, regular repositioning of oxygen devices, careful skin care and preventative nursing actions as a routine in the ICU. Evidence-based ear care procedures could contribute to minimizing HAIs, increase patient comfort and safety, shorten the length of stay and enhance the quality of critical care services, especially within limited resource health care systems.