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

April 1, 2026 updated by: University Hospital, Bordeaux

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patient hospitalized in an adult intensive care undergoing oro-tracheal intubation.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
intensive care patient with oro-tracheal intubation
Other: oral condition assessment tool
Use of the Mat assessment tool by a nurse on the participant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metrological performance of the Mouth Assessment Tool (MAT)
Time Frame: At inclusion (Day 0)
The general evaluation criterion is the tool's metrological performance according to COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) psychometric criteria.
At inclusion (Day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Content validity of the Mouth Assessment Tool (MAT)
Time Frame: At inclusion (Day 0)
Relevance of items, completeness of key concepts, understanding of items by target population
At inclusion (Day 0)
Construct validity of the Mouth Assessment Tool (MAT)
Time Frame: At inclusion (Day 0)
Structural validity of the dimensional tool Hypothesis testing Measurement invariance in different population subgroups
At inclusion (Day 0)
Reliability of the Mouth Assessment Tool (MAT)
Time Frame: At inclusion (Day 0)
Reproducibility Internal consistency
At inclusion (Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

August 27, 2024

First Submitted That Met QC Criteria

October 3, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHUBX 2023/48

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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