Mouth assessment tool for adults with oral intubation in intensive care
Development and Validation of a Mouth Assessment Tool for Orally Intubated Patients in Intensive Care Unit)
This project tries a new checklist nurses can use to check mouth health in adults who are orally intubated in intensive care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 10 sites (Angers and 9 other locations) |
| Trial ID | NCT06628440 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (18+) admitted to participating adult intensive care units who are undergoing oro-tracheal intubation and can provide consent or have a legal representative provide consent.
Not a fit: People who are not orally intubated, those under active limitation of therapy or protective supervision, or those with fixed dental appliances or major oral loss that prevents measurement are unlikely to benefit from this tool.
Why it matters
Potential benefit: If successful, the tool could standardize mouth checks, help detect intubation-related oral injuries earlier, and support better prevention and care.
How similar studies have performed: This approach is relatively novel because there is no validated oral-status tool specific to orally intubated patients, although various general mouth-care protocols exist.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Angers and 9 other locations
- 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 - Pellegrin — Bordeaux, France (Recruiting)
- CHU de Bordeaux - Saint André — Bordeaux, France (Not_yet_recruiting)
- CHU Caen — Caen, France (Not_yet_recruiting)
- CH Libourne — Libourne, France (Not_yet_recruiting)
- CHU de Bordeaux - Haut Levêque — Pessac, France (Not_yet_recruiting)
- Hôpital d'Instruction des Armées Sainte Anne — Toulon, France (Not_yet_recruiting)
- Hôpitaux Nord Franche comté — Trévenans, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Oriane BOUISSIERE
- Email: oriane.bouissiere@chu-bordeaux.fr
- Phone: 0556795361
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.