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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • oral condition assessment tool

    Other intervention

    Use of the Mat assessment tool by a nurse on the participant

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Patients1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At inclusion (Day 0)

Secondary outcomes

1

Content validity of the Mouth Assessment Tool (MAT)

Relevance of items, completeness of key concepts, understanding of items by target population

Time frame
At inclusion (Day 0)
2

Construct validity of the Mouth Assessment Tool (MAT)

Structural validity of the dimensional tool Hypothesis testing Measurement invariance in different population subgroups

Time frame
At inclusion (Day 0)
3

Reliability of the Mouth Assessment Tool (MAT)

Reproducibility Internal consistency

Time frame
At inclusion (Day 0)

Other outcomes

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