Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628440
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Development and Validation of a Mouth Assessment Tool for Orally Intubated Patients in Intensive Care Unit
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development and Validation of a Mouth Assessment Tool for Orally Intubated Patients in Intensive Care Unit
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAT
Brief Summary:
Oro-tracheal Intubation uses oro-pharyngeal lesions impacting on the length and quality of the patients 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
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
Detailed Description:
In France according to the medicalized information system program national database 230000 adults are admitted to the intensive care unit every year 40 of them undergoing invasive mechanical ventilation Thats 90000 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 patients hospital stay
As early as 48 hours after admission to intensive care the patients 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 patients 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 treatmentcare
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
OTI causes oro-pharyngeal lesions impacting on the length and quality of the patients hospital stay
As early as 48 hours after admission to intensive care the patients 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 patients 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 treatmentcare
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None