NCT06628440 Development and Validation of a Mouth Assessment Tool for Orally Intubated Patients in Intensive Care Unit)
| NCT ID | NCT06628440 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Intensive Care |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2026-03-31 |
| Primary Completion | 2028-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2026-03-31 with a primary completion date of 2028-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06628440 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intensive Care. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06628440 currently recruiting?
Yes, NCT06628440 is actively recruiting participants. Contact the research team at oriane.bouissiere@chu-bordeaux.fr for enrollment information.
Where is the NCT06628440 trial being conducted?
This trial is being conducted at Angers, France, Bordeaux, France, Bordeaux, France, Bordeaux, France and 6 additional locations.
Who is sponsoring the NCT06628440 clinical trial?
NCT06628440 is sponsored by University Hospital, Bordeaux. The trial plans to enroll 500 participants.