Oral Care Apparatus for Intubated Patients

NCT06709183 | Enrolling By Invitation

• 1 other identifier: 2024Phd
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care; Oral Care; Intubated ICU Patients

Keywords

intensive care; oral care; oral care retractor; intubated ICU patients

Outcome Measures

Primary Outcomes (2)

• Effect on oral care applications

  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).

  It will be filled 2 minutes after the end of the application.

• Oral cavity assessment

  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.

  It will be filled 2 minutes after the end of the application.

Study Arms (2)

Standard oral care (Control - intervention)

SHAM COMPARATOR

The nurses in the control-intervention group will perform standard oral care in the first oral care and oral care using the oral care retractor in the second oral care.

Other: Control - intervention

Oral care retractor (Intervention - Control)

ACTIVE COMPARATOR

The nurses in the intervention-control group will perform the first oral care with an oral care retractor, and in the second oral care, they will perform standard oral care without using an oral care retractor.

Other: Intervention-Control

Interventions

Intervention-Control OTHER

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.

Also known as: Oral care retractor

Oral care retractor (Intervention - Control)

Control - intervention OTHER

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..

Also known as: Standard oral care

Standard oral care (Control - intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Bitlis State Hospital

Bitlis, Merkez, 13200, Turkey (Türkiye)

Location

Related Publications (29)

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Assistant researcher
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Model Details: The research will be conducted through simulation using a standard mannequin in room 428 in the general intensive care unit. Room 428 in the general intensive care unit is a standard intensive care room with four walls of glass, 15 m2 in size, one supply cabinet, one cloakroom, oxygen panel, mechanical ventilator, monitor and single bed, where patients can be monitored instantly with a camera system. In our study, this intensive care room will be used to evaluate the effectiveness of the oral care retractor designed for intensive care patients in order to ensure that oral care procedures to be applied by nurses are in a realistic environment and that nurses feel as if they are applying to a live patient. Simulation method will be used for the experimental study part of this research. Laerdal brand MegaCode Kelly emergency care simulator will be used in the study.

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 29, 2024
• Study Start: January 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 1, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)