NCT06709183

Oral Care Apparatus for Intubated Patients

The Effect of Oral Care Retractor Developed for Intubated Patients in Intensive Care Unit on Oral Care Practices

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Saglik Bilimleri Universitesi · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

There are several practical challenges in providing oral care to intubated patients. The presence of an endotracheal tube often makes it difficult to thoroughly evaluate the oral cavity, and there is a risk of tube displacement or removal during oral care. Additionally, the lack of standardized care protocols, limited time, and inadequate equipment further complicate the assessment of oral mucosal membranes, increase the likelihood of complications, and prolong ICU stays. The literature also highlights that intubated patients often exhibit behaviors such as gagging, biting the tube, or turning their head during oral care. These actions make it challenging for ICU nurses to use oral care tools effectively, resulting in insufficient evaluation and cleaning of the oral cavity. In a study conducted by Dale et al., ICU healthcare workers emphasized the need for an oral device that could withstand biting pressure, keep the teeth separated, and be flexible enough to prevent discomfort while enabling effective oral care. However, the literature does not report the existence of a device designed to open the oral cavity for intubated patients during oral care. Inspired by cheek retractors used in dentistry, this project aims to design an oral care retractor specifically for intubated patients. This device would facilitate the evaluation of the oral cavity and provide a clear view during oral care, enabling effective oral hygiene practices.

Detailed description

Intensive care units (ICUs) are facilities where basic and advanced life support are provided for patients who are completely bedridden, unable to perform daily living activities, and require constant nursing care. These patients often receive oxygen therapy or mechanical ventilation. Most ICU patients are dependent on nursing care, placing significant responsibilities on ICU nurses to meet self-care needs. One of these essential self-care interventions is oral care. Oral care includes approaches such as assessing the oral cavity, maintaining saliva production, preventing the formation of microorganisms, reducing plaque and related diseases, and cleaning and moisturizing oral tissues. Effective oral care provides comfort and helps prevent infections. The absence of regular and effective oral care in ICU patients allows pathogens to proliferate in the oral cavity, increasing microbial load. Patients undergoing endotracheal intubation and mechanical ventilation are particularly at risk for developing systemic infections such as oral infections or healthcare-associated pneumonia. Endotracheal tubes can lead to debris accumulation, create an environment conducive to microbial growth, and keep the mouth continuously open, resulting in xerostomia, dental plaque buildup, and reduced saliva production. Oral care reduces bacterial colonization in the oropharyngeal cavity and prevents adverse outcomes such as poor oral health and respiratory infections. There are, however, practical challenges in providing oral care to intubated patients. These challenges include difficulty in thoroughly assessing the oral cavity due to the presence of the endotracheal tube, the risk of tube displacement or removal during oral care, the lack of standardized care protocols, and limited time and equipment. These factors complicate the evaluation of oral mucosal membranes, increase the likelihood of complications, and prolong hospital stays. Additionally, the literature notes that intubated patients often exhibit challenging behaviors during oral care, such as gagging, biting the tube, or turning their head, making it difficult for ICU nurses to use oral care tools effectively. This can result in insufficient evaluation and cleaning of the oral cavity. In a study by Dale et al., ICU healthcare workers expressed the need for an oral device that could resist biting pressure, keep the teeth separated, and be flexible enough to prevent discomfort while enabling effective oral care. Inspired by cheek retractors used in dentistry, we designed an oral care retractor to facilitate the evaluation of the oral cavity in intubated patients and enable clear visualization during oral care. This study aims to assess the impact of this newly developed oral care retractor on oral care practices in intubated patients in the ICU.

Conditions

• Intensive Care
• Oral Care
• Intubated ICU Patients

Interventions

Type	Name	Description
OTHER	Intervention-Control	Nurses in this group will start the first oral care practice by using the oral care retractor on the model. Before starting the procedure, the nurses will fill in the 'Beck Mouth Assessment Guide' and after the procedure, they will fill in the 'Oral Care Practices Evaluation Form'. A rest period of at least 10 minutes will be provided before the second oral care application. Standard oral care will be applied during the second application. Similarly, nurses will complete the 'Beck Oral Assessment Guide' before the procedure and the 'Oral Care Practices Assessment Form' after the procedure. At the end of both procedures, nurses will complete the 'Quebec Assistive Technology User Satisfaction Assessment Questionnaire (Q-ATUSA)' and the 'Interview Form'. The 'Interview Form' will be used to collect nurses' experiences and opinions about the oral care procedure. During the interview, audio recordings will be made with the knowledge of the nurses.
OTHER	Control - intervention	In the first oral care procedure, nurses in this group will perform standard oral care on the model without using the oral care retractor. They will complete the 'Beck Oral Assessment Guide' before the procedure and the 'Oral Care Practices Evaluation Form' after the procedure. There will be a rest period of at least 10 minutes before the second oral care procedure. During this procedure, the second group of nurses who initially perform standard oral care will perform oral care using an oral care retractor. Similarly, they will complete the 'Beck Oral Assessment Guide' before the procedure and the 'Oral Care Practices Evaluation Form' after the procedure. At the end of both procedures, nurses will complete the 'Quebec Assistive Technology User Satisfaction Assessment Questionnaire (Q-ATUSA)' and the 'Interview Form'. The 'Interview Form' will be used to obtain nurses' experiences and opinions regarding oral care practices..

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-09-30
• Completion: 2025-12-01
• First posted: 2024-11-29
• Last updated: 2024-11-29

Locations

1 site across 1 country: Turkey (Türkiye)