Mouth assessment tool for adults with oral intubation in intensive care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The team developed a purpose-built oral cavity assessment tool for adults receiving oro-tracheal intubation and will test its measurement properties in real ICU patients. Trained caregivers will apply the tool to intubated patients in participating French university hospitals and record findings repeatedly to measure reliability and feasibility. The protocol examines inter-rater reproducibility, clinical usability at the bedside, and how well the tool captures mouth lesions compared with routine clinical observations. Results will determine whether the tool is reliable and practical for routine use in intensive care settings.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU de Bordeaux - Pellegrin
  Bordeaux, France Recruiting
• CHU Angers
  Angers, France Not yet recruiting
• CHU de Bordeaux - Aile 1 Tripode
  Bordeaux, France Not yet recruiting
• CHU de Bordeaux - Aile 2 Tripode
  Bordeaux, France Not yet recruiting
• CHU de Bordeaux - Saint André
  Bordeaux, France Not yet recruiting
• CHU Caen
  Caen, France Not yet recruiting

Study contacts

• Study coordinator: Oriane BOUISSIERE
• Email: oriane.bouissiere@chu-bordeaux.fr
• Phone: 0556795361

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.