Intensive CareMATNCT06628440
Development and Validation of a Mouth Assessment Tool for Orally Intubated Patients in Intensive Care Unit)
An observational study of Intensive Care, run by University Hospital, Bordeaux at 10 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care
- What is being tested?
- oral condition assessment tool
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- 10 sitesFrance
- Study dates
- 31 Mar 2026to Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient hospitalized in an adult intensive care undergoing oro-tracheal intubation.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
France10 sites, 10 recruiting
- Not yet recruiting
CHU Angers
Angers
Carole HAUBERTIN, Carole.haubertin@chu-angers.fr
- Not yet recruiting
CHU de Bordeaux - Aile 1 Tripode
Bordeaux
Pierre GODARD, Dr, pierre.godard.ext@chu-bordeaux.fr
- Not yet recruiting
CHU de Bordeaux - Aile 2 Tripode
Bordeaux
Vivien GUILLOTIN, Dr, vivien.guillotin@chu-bordeaux.fr
- Recruiting
CHU de Bordeaux - Pellegrin
Bordeaux
Hugues De Courson, Dr, hugues.de-courson@chu-bordeaux.fr
- Not yet recruiting
CHU de Bordeaux - Saint André
Bordeaux
Renaud Prevel, Dr, renaud.prevel@chu-bordeaux.fr
- Not yet recruiting
CHU Caen
Caen
Agathe HAMELIN, Dr, Hamelin-a@chu-caen.fr
- Not yet recruiting
CH Libourne
Libourne
Hubert GRAND, Dr, Hubert.grand@ch-libourne.fr
- Not yet recruiting
CHU de Bordeaux - Haut Levêque
Pessac
Antoine BEURTON, Dr, antoine.beurton@chu-bordeaux.fr
- Not yet recruiting
Hôpital d'Instruction des Armées Sainte Anne
Toulon
Fanny GIANNONI, Fanny.giannoni@intradef.gouv.fr
- Not yet recruiting
Hôpitaux Nord Franche comté
Trévenans
Valérie CHAUVIN, Dr, Valerie.chauvin@hnfc.fr
About this study
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.
Read the 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.
- Conditions
- Intensive Care
- Being tested
- oral condition assessment tool
- Keywords
- intensive care, oral care, paramedical care, oro-tracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral condition assessment toolOther
Use of the Mat assessment tool by a nurse on the participant
| Study group | Role | What they receive |
|---|---|---|
| Patients | intensive care patient with oro-tracheal intubation Receives: Other: oral condition assessment tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metrological performance of the Mouth Assessment Tool (MAT)
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.
Measured: At inclusion (Day 0)
Secondary outcomes (3)
Content validity of the Mouth Assessment Tool (MAT)
Relevance of items, completeness of key concepts, understanding of items by target population
Measured: At inclusion (Day 0)
Construct validity of the Mouth Assessment Tool (MAT)
Structural validity of the dimensional tool Hypothesis testing Measurement invariance in different population subgroups
Measured: At inclusion (Day 0)
Reliability of the Mouth Assessment Tool (MAT)
Reproducibility Internal consistency
Measured: At inclusion (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start31 Mar 2026
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive CareStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628440
- Sponsor's protocol ID
- CHUBX 2023/48
- Acronym
- MAT
- Status last verified
- Apr 2026
- First submitted
- 27 Aug 2024
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Mouth Assessment Tool for Orally Intubated Patients in Intensive Care Unit)
- ClinicalTrials.gov ID
- NCT06628440
- Acronym / sponsor ID
- MAT / CHUBX 2023/48
- Conditions
- Intensive Care
- Keywords
- intensive care, oral care, paramedical care, oro-tracheal intubation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: oral condition assessment toolintensive care patient with oro-tracheal intubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient hospitalized in an adult intensive care undergoing oro-tracheal intubation.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral condition assessment toolUse of the Mat assessment tool by a nurse on the participant | Other | Patients |
Primary outcome
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.
3 secondary outcomes
Content validity of the Mouth Assessment Tool (MAT)
Time frame: At inclusion (Day 0)
Construct validity of the Mouth Assessment Tool (MAT)
Time frame: At inclusion (Day 0)
Reliability of the Mouth Assessment Tool (MAT)
Time frame: At inclusion (Day 0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care, run by University Hospital, Bordeaux at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oriane BOUISSIERE (0556795361 ext. 33, oriane.bouissiere@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metrological performance of the Mouth Assessment Tool (MAT) (time frame: At inclusion (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.