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ClinicalTrials.gov ID

NCT06628440

Lead Sponsor

University Hospital, BordeauxOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

500Estimated

Last Update Posted

Apr 7, 2026Actual

Start Date

Mar 31, 2026Actual

Primary Completion Date

Oct 2028Estimated

Completion Date

Oct 2028Estimated

Official Title

Development and Validation of a Mouth Assessment Tool for Orally Intubated Patients in Intensive Care Unit)

Brief Summary

Oro-tracheal Intubation uses oro-pharyngeal lesions, impacting on the length and quality of the patient's hospital stay.

There are no oral status assessment tools specifically adapted to orally intubated patients.

It is therefore necessary to create a new tool for assessing the condition of the oral cavity, specific to oro-intubated patients in intensive care.

The aim of the protocol is to evaluate the metrological performance of the newly-developed tool for assessing the state of the oral cavity in adult orally intubated intensive care patients.

Detailed Description

In France, according to the "medicalized information system program" national database, 230,000 adults are admitted to the intensive care unit every year, 40% of them undergoing invasive mechanical ventilation. That's 90,000 patients for whom an Oro-Tracheal Intubation (OTI) tube is inserted through the mouth into the trachea.

OTI causes oro-pharyngeal lesions, impacting on the length and quality of the patient's hospital stay.

As early as 48 hours after admission to intensive care, the patient's oral and dental condition deteriorates. Pressure lesions can occur, with the OTI probe responsible for 22% to 26% of pressure sores related to invasive equipment. Anarchic chewing also causes injuries to lips, tongue, gums, mucosa and teeth.

In time, these injuries can lead to swallowing disorders, a mechanism for feeding and protecting the airways, and impair the patient's quality of life.

Caregivers in intensive care units have developed mouth care protocols to maintain hygiene and comfort, and prevent lesions that can spread from the lips to the trachea during OTI.

Many mouth care protocols exist, but there is no "gold standard". Certain practices are encouraged as part of the prevention of Ventilator-Acquired Pneumonia (VAP) (mainly tooth brushing). Mouth care practices in France remain highly heterogeneous. In order to improve practices, it is essential not only to have best practice guidelines for preventing and treating lesions, but also to have appropriate and valid tools for assessing the oral condition of intubated patients. Good assessment is a prerequisite for good treatment/care.

To investigators knowledge, there are no oral status assessment tools specifically adapted to intubated patients.

Tools do exist for populations at risk due to age or chemotherapy, but these have often been created without multidisciplinary advice, validated in a population without OTI, and do not allow for an assessment of the state of the oral cavity appropriate to the problems of intubated patients.

It is therefore necessary to create a new tool for assessing the condition of the oral cavity, specific to oro-intubated patients in intensive care, by bringing together experts in intensive care, oral health, hygiene, wound healing and patient partners, and to validate it in this patient population. The tool must also be relevant to the fields of competence of nurses, for use in daily practice.

The aim of the protocol is to evaluate the metrological performance of the newly-developed tool for assessing the state of the oral cavity in adult oro-intubated intensive care patients.

• Intensive Care

• oral condition assessment tool

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Person aged 18 or over
• Person hospitalized in an adult intensive care unit for medical, surgical, polyvalent or burns specialties.
• Person undergoing oro-tracheal intubation.
• Person affiliated with or benefiting from a social security scheme.
• Free and informed oral consent of the patient or his/her legal representative

Exclusion Criteria:

• Person undergoing Limitation or Cessation of Active Therapeutics
• Person wearing a multi-attachment fixed dental appliance (braces, multi-rings, brackets bonded to teeth)
• Person with oral damage making it impossible to measure one of the items on the oral cavity assessment tool (e.g.: removal of the tongue, etc.).
• Patient under protective supervision (safeguard of justice, curatorship, guardianship)
• Refusal of patient or legal representative to participate

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

University Hospital, BordeauxOTHER

Hamelin-a@chu-caen.fr