Oral Care Apparatus for Intubated Patients

Not Applicable

• Conditions: Intensive Care; Oral Care; Intubated ICU Patients

• Registration Number: NCT06709183
• Lead Sponsor: Saglik Bilimleri Universitesi

Brief 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.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2024-11-27
• Last Update Submitted: 2024-11-27
• Study First Posted: 2024-11-28
• Last Update Posted: 2024-11-28
• Study Start: 2025-01-01
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Volunteering to participate in the study,
• Having at least 6 months of work experience in an intensive care unit (Sayın, 2020),
• Working as a nurse in adult intensive care units.

Exclusion Criteria

• Working as a nurse in a neonatal intensive care unit.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Effect on oral care applications	It will be filled 2 minutes after the end of the application.	Whether the oral care retractor has an effect on oral care practices in intubated patients will be evaluated with the Oral Care Practice Evaluation Form. This form was created by the researcher in line with the literature (Dagnew et al., 2020; Dale et al., 2018; Thapa \& Shrestha, 2019) and consists of 4 questions. Nurses will be asked to rate the oral care practice according to the Visual Analogue Scale (VAS) between 0 and 10. VAS ratings will be categorised as low (0-3), medium (4-6) and high (7-10) (Dale et al., 2018).
Oral cavity assessment	It will be filled 2 minutes after the end of the application.	It will be examined whether the oral care retractor has an effect on the assessment of the oral cavity of intubated patients. Beck oral cavity assessment form will be used for this purpose.This scale was developed by Becks (1979). It has five subscales: lips, gums, oral mucosa, tongue, teeth and saliva, each scored on a four-point Likert scale. The total score of this tool is 5-20. A low score indicates good oral health and a high score indicates the presence of problems. Therefore, 5-10 points indicate mild dysfunction, 11-15 points indicate moderate dysfunction and 16-20 points indicate severe dysfunction.

Trial Locations

Locations (1)

Bitlis State Hospital; 🇹🇷 Bitlis, Merkez, Turkey