Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078663
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2004-03-03
Brief Title:
Oral Care to Reduce Mouth and Throat Infections in Critically Ill Patients
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Effect of a Systemic Oral Care Program on Reducing Exposure to Oropharyngeal Pathogens in Critically III Patients
Status:
COMPLETED
Status Verified Date:
2011-08-16
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate whether a program of systematic oral care can help prevent hospital-acquired respiratory infections in patients in intensive care units Such infections occur five times more often in critically ill patients compared with patients in general hospital wards and result in longer hospital stays and an increased risk of death The rate of respiratory infection among critically ill patients correlates strongly with the presence of disease-causing bacteria in the mucosal areas of the mouth gums and teeth indicating that assiduous oral care is especially important in this patient population This study will compare a program of meticulous oral care using oral assessments taught by a dentist and dental hygienist with the standard care typically given in intensive care units
Critically ill patients 18 years of age and older who are hospitalized in an intensive care unit for 3 or more days and whose oral hygiene is dependent on hospital care providers may be eligible for this study Patients will be recruited from intensive care units at four Washington DC area hospitals - Suburban Hospital Washington Hospital Center Inova Fairfax Hospital and Winchester Medical Center
Participants will have their lips mouth gums teeth and saliva examined several times a day to determine their optimum oral care They will receive standard care such as flossing brushing rinsing with a mouthwash and possibly use of an antiseptic spray that prevents bacteria from clinging to the teeth Small samples of saliva less than one-fourth of a teaspoon and dental plaque will be collected the day the patient is admitted to the intensive care unit and again on days 3 and 5 of their stay in the unit The saliva sample is collected with a small suction tube placed in the corner of the mouth the plaque specimen is collected by gliding a tiny piece of paper over the surface of a front tooth The samples will be examined for any bacteria not normally found in saliva
Critically ill patients 18 years of age and older who are hospitalized in an intensive care unit for 3 or more days and whose oral hygiene is dependent on hospital care providers may be eligible for this study Patients will be recruited from intensive care units at four Washington DC area hospitals - Suburban Hospital Washington Hospital Center Inova Fairfax Hospital and Winchester Medical Center
Participants will have their lips mouth gums teeth and saliva examined several times a day to determine their optimum oral care They will receive standard care such as flossing brushing rinsing with a mouthwash and possibly use of an antiseptic spray that prevents bacteria from clinging to the teeth Small samples of saliva less than one-fourth of a teaspoon and dental plaque will be collected the day the patient is admitted to the intensive care unit and again on days 3 and 5 of their stay in the unit The saliva sample is collected with a small suction tube placed in the corner of the mouth the plaque specimen is collected by gliding a tiny piece of paper over the surface of a front tooth The samples will be examined for any bacteria not normally found in saliva
Detailed Description:
Critically ill patients especially those that require endotracheal intubation have the greatest risk of any hospitalized patient for acquiring nosocomial pneumonia Nosocomial pneumonia in this population produces a substantial increase of mortality and morbidity The literature suggests the causative pathway is aspiration of oropharyngeal pathogens found in dental plaque The build-up of dental plaque has been significantly associated with subsequent nosocomial respiratory infections Thus prevention of pathogens colonization in the oropharyngeal cavity could be an effective infection control measure
Dental plaque once it reaches a critical thickness acts as a reservoir for both aerobic and anaerobic pathogens Failure to remove plaque begins a complex cascade of biological activity by which pathogens adhere to mucosal and tooth surfaces and pathogen overgrowth ensues Additionally neglected or insufficient mouth care is the foremost predisposing factor to oral conditions such as gingivitis mucositis and stomatitis which supply additional ports of entry for pathogens
There are only a handful of studies that compare the frequency and type of oral hygiene required to prevent or decrease oropharyngeal colonization A recent pilot study 01-CC-0207 compared oral care provision in two intensive care units ICU in the Clinical Center The test ICU offered meticulous oral hygiene through a system of regular oral assessments taught by a dentist and dental hygienist The score from the assessment determined the type and frequency of oral care The control ICU gave standard care typical of the ICU community Plaque and saliva assays were collected from the enrolled patients Significantly lower Beck scores and lower colony forming organisms in the specimens was achieved in the test ICU on day 3 p less than 003 and p less than 0001 respectively
This protocol will expand the pilot into a prospective randomized assigned trial conducted at four hospitals in the Washington DC area These hospitals have ICUs more representative of ICUs nation-wide This study will test the effectiveness of a comprehensive and systematic oral care program to reduce the oral assessment scores mucosal plaque scores and the amount of pathogen inoculum present in the saliva and plaque Intubated and non-intubated patients will be compared as well as meticulous care with or without the addition of the oral antiseptic chlorhexidine Consistency of practice performance will also be evaluated when nursing staff has dentisthygienist instruction and monitoring versus the traditional nurse instruction
Dental plaque once it reaches a critical thickness acts as a reservoir for both aerobic and anaerobic pathogens Failure to remove plaque begins a complex cascade of biological activity by which pathogens adhere to mucosal and tooth surfaces and pathogen overgrowth ensues Additionally neglected or insufficient mouth care is the foremost predisposing factor to oral conditions such as gingivitis mucositis and stomatitis which supply additional ports of entry for pathogens
There are only a handful of studies that compare the frequency and type of oral hygiene required to prevent or decrease oropharyngeal colonization A recent pilot study 01-CC-0207 compared oral care provision in two intensive care units ICU in the Clinical Center The test ICU offered meticulous oral hygiene through a system of regular oral assessments taught by a dentist and dental hygienist The score from the assessment determined the type and frequency of oral care The control ICU gave standard care typical of the ICU community Plaque and saliva assays were collected from the enrolled patients Significantly lower Beck scores and lower colony forming organisms in the specimens was achieved in the test ICU on day 3 p less than 003 and p less than 0001 respectively
This protocol will expand the pilot into a prospective randomized assigned trial conducted at four hospitals in the Washington DC area These hospitals have ICUs more representative of ICUs nation-wide This study will test the effectiveness of a comprehensive and systematic oral care program to reduce the oral assessment scores mucosal plaque scores and the amount of pathogen inoculum present in the saliva and plaque Intubated and non-intubated patients will be compared as well as meticulous care with or without the addition of the oral antiseptic chlorhexidine Consistency of practice performance will also be evaluated when nursing staff has dentisthygienist instruction and monitoring versus the traditional nurse instruction
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-CC-0130 | None | None | None |