Actively Recruiting
Development and Validation of a Mouth Assessment Tool for Orally Intubated Patients in Intensive Care Unit
Led by University Hospital, Bordeaux · Updated on 2026-04-07
500
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate a newly developed tool designed to assess the condition of the oral cavity in adult patients who are orally intubated in intensive care units. Oro-tracheal intubation often causes lesions in the mouth and throat, which can affect the patient's hospital stay and quality of life. Currently, no assessment tools are specifically adapted for these intubated patients, highlighting the need for a specialized evaluation method. The study involves using the new Mouth Assessment Tool (MAT) by nurses to evaluate the oral condition of adults undergoing oro-tracheal intubation in intensive care. This tool has been created with input from experts in intensive care, oral health, hygiene, wound healing, and patient partners to ensure relevance and usability in daily nursing practice. The study will assess the tool's metrological performance, content validity, construct validity, and reliability at the time of patient inclusion. Participants will be adults in intensive care who are orally intubated. Nurses will use the MAT to assess oral health at inclusion (Day 0). Researchers will monitor how well the tool measures oral condition, its validity, and consistency. The study will evaluate the tool's ability to support better mouth care protocols and improve patient outcomes by providing accurate assessments. The trial is observational and will continue until October 2028.
CONDITIONS
Brief Title
Development and Validation of a Mouth Assessment Tool for Orally Intubated Patients in Intensive Care Unit)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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)
- Patient under protective supervision (safeguard of justice, curatorship, guardianship)
- Refusal of patient or legal representative to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day at inclusion (Day 0)
Participants undergo oral condition assessment using the Mouth Assessment Tool by a nurse to evaluate the state of the oral cavity while intubated in intensive care.
1 assessment visit (in-person)
Duration - Up to intensive care stay duration
Participants are observed to validate the performance of the Mouth Assessment Tool during their intensive care stay.
Visits as per routine intensive care monitoring
Trial Site Locations
Total: 10 locations
1
CHU Angers
Angers, France
Not Yet Recruiting
2
CHU de Bordeaux - Aile 1 Tripode
Bordeaux, France
Not Yet Recruiting
3
CHU de Bordeaux - Aile 2 Tripode
Bordeaux, France
Not Yet Recruiting
4
CHU de Bordeaux - Pellegrin
Bordeaux, France
Actively Recruiting
5
CHU de Bordeaux - Saint André
Bordeaux, France
Not Yet Recruiting
6
CHU Caen
Caen, France
Not Yet Recruiting
7
CH Libourne
Libourne, France
Not Yet Recruiting
8
CHU de Bordeaux - Haut Levêque
Pessac, France
Not Yet Recruiting
9
Hôpital d'Instruction des Armées Sainte Anne
Toulon, France
Not Yet Recruiting
10
Hôpitaux Nord Franche comté
Trévenans, France
Not Yet Recruiting
Research Team
O
Oriane BOUISSIERE
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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