Development and Validation of a Mouth Assessment Tool for Orally Intubated Patients in Intensive Care Unit)
Recruiting now
Conditions studied: Intensive Care
In brief
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.
Key facts
- Study ID
- NCT06628440
- Run by
- University Hospital, Bordeaux
- People needed
- 500
- Starts
- 2026-03-31
- Expected to finish
- 2028-10-01
- Last updated by the study team
- 2026-04-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- CHU de Bordeaux - Pellegrin — Bordeaux, France (enrolling)
- CHU de Bordeaux - Aile 1 Tripode — Bordeaux, France
- CHU de Bordeaux - Aile 2 Tripode — Bordeaux, France
- CHU de Bordeaux - Saint André — Bordeaux, France
- CHU Caen — Caen, France
- CH Libourne — Libourne, France
- CHU de Bordeaux - Haut Levêque — Pessac, France
- Hôpital d'Instruction des Armées Sainte Anne — Toulon, France
- CHU Angers — Angers, France
- Hôpitaux Nord Franche comté — Trévenans, France
Full record on ClinicalTrials.gov
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