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

NCT06628440 | Not Yet Recruiting

• 1 other identifier: CHUBX 2023/48
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 10

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.

Conditions

Intensive Care

Keywords

intensive care; oral care; paramedical care; oro-tracheal intubation

Outcome Measures

Primary Outcomes (1)

• Metrological performance of the Mouth Assessment Tool (MAT)

  The general evaluation criterion is the tool's metrological performance according to COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) psychometric criteria.

  At inclusion (Day 0)

Secondary Outcomes (3)

• Content validity of the Mouth Assessment Tool (MAT)

  At inclusion (Day 0)

• Construct validity of the Mouth Assessment Tool (MAT)

  At inclusion (Day 0)

• Reliability of the Mouth Assessment Tool (MAT)

  At inclusion (Day 0)

Study Arms (1)

Patients

intensive care patient with oro-tracheal intubation

Other: oral condition assessment tool

Interventions

oral condition assessment tool OTHER

Use of the Mat assessment tool by a nurse on the participant

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient hospitalized in an adult intensive care undergoing oro-tracheal intubation.

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (10)

CHU Angers

Angers, France

Location

CHU de Bordeaux - Aile 1 Tripode

Bordeaux, France

Location

CHU de Bordeaux - Aile 2 Tripode

Bordeaux, France

Location

CHU de Bordeaux - Pellegrin

Bordeaux, France

Location

CHU de Bordeaux - Saint André

Bordeaux, France

Location

CHU Caen

Caen, France

Location

CH Libourne

Libourne, France

Location

CHU de Bordeaux - Haut Levêque

Pessac, France

Location

Hôpital d'Instruction des Armées Sainte Anne

Toulon, France

Location

Hôpitaux Nord Franche comté

Trévenans, France

Location

Central Study Contacts

Oriane BOUISSIERE

CONTACT

0556795361; oriane.bouissiere@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: October 8, 2024
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10)