Development and Validation of a Mouth Assessment Tool for Orally Intubated Patients in Intensive … (NCT06628440) | Clinical Trial Compass
RecruitingNot Applicable
Development and Validation of a Mouth Assessment Tool for Orally Intubated Patients in Intensive Care Unit)
France500 participantsStarted 2026-03-31
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Metrological performance of the Mouth Assessment Tool (MAT)