Status:

RECRUITING

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

Lead Sponsor:

University Hospital, Bordeaux

Conditions:

Intensive Care

Eligibility:

All Genders

18+ years

Brief Summary

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 intub...

Detailed Description

In France, according to the "medicalized information system program" national database, 230,000 adults are admitted to the intensive care unit every year, 40% of them undergoing invasive mechanical ve...

Eligibility Criteria

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

Key Trial Info

Start Date :

March 31 2026

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

October 1 2028

Estimated Enrollment :

500 Patients enrolled

Trial Details

Trial ID

NCT06628440

Start Date

March 31 2026

End Date

October 1 2028

Last Update

April 7 2026

Active Locations (10)

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Page 1 of 3 (10 locations)

1

CHU Angers

Angers, France

2

CHU de Bordeaux - Aile 1 Tripode

Bordeaux, France

3

CHU de Bordeaux - Aile 2 Tripode

Bordeaux, France

4

CHU de Bordeaux - Pellegrin

Bordeaux, France