About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial population
Patient hospitalized in an adult intensive care undergoing oro-tracheal intubation.
Trial design
Cohort
Prospective
Treatments tested in this trial
oral condition assessment tool
Other interventionUse of the Mat assessment tool by a nurse on the participant
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Content validity of the Mouth Assessment Tool (MAT)
Relevance of items, completeness of key concepts, understanding of items by target population
Construct validity of the Mouth Assessment Tool (MAT)
Structural validity of the dimensional tool Hypothesis testing Measurement invariance in different population subgroups
Reliability of the Mouth Assessment Tool (MAT)
Reproducibility Internal consistency
Sponsors and contacts
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