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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-30

Study Completion Date

2027-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Oral Care Apparatus for Intubated Patients

NCT06709183

Intensive Care Oral Care Intubated ICU Patients

ENROLLING_BY_INVITATION NA

Post Intubation Laryngeal Hazards in Children in the Pediatric Intensive Care Unit

NCT06198634

Laryngeal Injury

NOT_YET_RECRUITING

Oral Mucosal Pressure Injury in ICU Patients With Oral Tracheal Intubation

NCT05882539

Oral Mucosal Pressure Injury

UNKNOWN

Awake Tracheal Intubation in Critical Care Patients

NCT05802316

Videolaryngoscopy Intensive Care Unit Syndrome

COMPLETED

Intubation Checklist in the Intensive Care Unit

NCT06791317

Critical Illness Respiratory Failure Unconsciousness

ACTIVE_NOT_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 ventilation. That's 90,000 patients for whom an Oro-Tracheal Intubation (OTI) tube is inserted through the mouth into the trachea.

OTI causes oro-pharyngeal lesions, impacting on the length and quality of the patient's hospital stay.

As early as 48 hours after admission to intensive care, the patient's oral and dental condition deteriorates. Pressure lesions can occur, with the OTI probe responsible for 22% to 26% of pressure sores related to invasive equipment. Anarchic chewing also causes injuries to lips, tongue, gums, mucosa and teeth.

In time, these injuries can lead to swallowing disorders, a mechanism for feeding and protecting the airways, and impair the patient's quality of life.

Caregivers in intensive care units have developed mouth care protocols to maintain hygiene and comfort, and prevent lesions that can spread from the lips to the trachea during OTI.

Many mouth care protocols exist, but there is no "gold standard". Certain practices are encouraged as part of the prevention of Ventilator-Acquired Pneumonia (VAP) (mainly tooth brushing). Mouth care practices in France remain highly heterogeneous. In order to improve practices, it is essential not only to have best practice guidelines for preventing and treating lesions, but also to have appropriate and valid tools for assessing the oral condition of intubated patients. Good assessment is a prerequisite for good treatment/care.

To investigators knowledge, there are no oral status assessment tools specifically adapted to intubated patients.

Tools do exist for populations at risk due to age or chemotherapy, but these have often been created without multidisciplinary advice, validated in a population without OTI, and do not allow for an assessment of the state of the oral cavity appropriate to the problems of 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, by bringing together experts in intensive care, oral health, hygiene, wound healing and patient partners, and to validate it in this patient population. The tool must also be relevant to the fields of competence of nurses, for use in daily practice.

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 oro-intubated intensive care patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intensive Care

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients

intensive care patient with oro-tracheal intubation

oral condition assessment tool

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

oral condition assessment tool

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No