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Oral Care Apparatus for Intubated Patients

Study acronym: Oral Care
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Notable Results posted: Oct 5, 2026 Show 9 more changesShow less
    • Start date changed from estimate of Jan 1, 2025 to Dec 1, 2025
    • Trial status changed: Enrolling by Invitation → Completed
    • Primary completion date changed from estimate of Sep 30, 2025 to Dec 28, 2025
    • Enrollment target: estimated 30 to confirmed 32
    • Study completion date changed from estimate of Dec 1, 2025 to Feb 28, 2026
    • Primary endpoints revised (2)
    • Collaborators expanded, about 8 words
    • Publications: details revised at 29 of 29 entries
    • Eligibility criteria expanded, about 4 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06709183
Lead Sponsor Saglik Bilimleri Universitesi
Collaborators: The Scientific and Technological Research Council of Turkey
Conditions
(from sponsor)
Intensive Care, Oral Care, Intubated ICU Patients
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov