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

Recruitingn/aAges 18 Years - anyAllUniversity Hospital, Bordeaux
NCT06628440 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • oral condition assessment tool
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Where

10 sites
CHU Angers
Angers, France
CHU de Bordeaux - Aile 1 Tripode
Bordeaux, France
CHU de Bordeaux - Aile 2 Tripode
Bordeaux, France
CHU de Bordeaux - Pellegrin
Bordeaux, France
CHU de Bordeaux - Saint André
Bordeaux, France
CHU Caen
Caen, France
CH Libourne
Libourne, France
CHU de Bordeaux - Haut Levêque
Pessac, France

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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