Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123123
Status:
COMPLETED
Last Update Posted:
2021-05-05
First Post:
2005-07-21
Brief Title:
Effect of Improved Oral Hygiene to Prevent Pneumonia in Hospitalized Patients
Sponsor:
State University of New York at Buffalo
Organization:
State University of New York at Buffalo
Study Overview
Official Title:
Oral Health and Ventilator-associated Pneumonia
Status:
COMPLETED
Status Verified Date:
2010-08
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:
Recent studies have found that poor oral hygiene may foster the colonization of the oropharynx by potential respiratory pathogens in mechanically-ventilated MV intensive care unit ICU patients Thus improvements in oral hygiene in MV-ICU patients may prevent ventilator-associated pneumonia VAP
The specific aims of this investigation are 1 to organize the necessary infrastructure to develop and perform a pilot clinical trial to evaluate alternative oral hygiene procedures to prevent VAP 2 to use this organization to perform a pilot clinical trial to determine if the use of oral topical chlorhexidine gluconate CHX will prevent dental plaque oropharyngeal colonization by respiratory pathogens and VAP in MV-ICU patients
The specific aims of this investigation are 1 to organize the necessary infrastructure to develop and perform a pilot clinical trial to evaluate alternative oral hygiene procedures to prevent VAP 2 to use this organization to perform a pilot clinical trial to determine if the use of oral topical chlorhexidine gluconate CHX will prevent dental plaque oropharyngeal colonization by respiratory pathogens and VAP in MV-ICU patients
Detailed Description:
Recent studies have found that poor oral hygiene may foster the colonization of the oropharynx by potential respiratory pathogens in mechanically-ventilated MV intensive care unit ICU patients Thus improvements in oral hygiene in MV-ICU patients may prevent ventilator-associated pneumonia VAP The Specific Aims of this investigation are 1 to organize the necessary infrastructure to develop and perform a pilot clinical trial to evaluate alternative oral hygiene procedures to prevent VAP 2 to use this organization to perform a pilot clinical trial to determine if the use of oral topical chlorhexidine gluconate CHX will prevent dental plaque oropharyngeal colonization by respiratory pathogens and VAP in MV-ICU patients This pilot longitudinal double blind intervention study will consider the appropriate frequency of delivery of CHX to improve oral hygiene in MV-ICU patients Preliminary data from these pilot studies will also allow accurate sample size calculations to be made for a large-scale multi-center clinical trial and 3 to perform molecular epidemiological studies to identify and genetically type bacteria cultured from lower airway secretions of MV-ICU patients with or without VAP and compare them to isolates of the same species from their dental plaque
This pilot study will enable this multidisciplinary team of investigators to organize the infrastructure patient recruitment and methodologic protocols and data management and analysis procedures necessary to perform a multi-center controlled clinical trial to assess the efficacy and generalizability of this intervention to improve oral hygiene in MV-ICU and prevent VAP
This pilot study will enable this multidisciplinary team of investigators to organize the infrastructure patient recruitment and methodologic protocols and data management and analysis procedures necessary to perform a multi-center controlled clinical trial to assess the efficacy and generalizability of this intervention to improve oral hygiene in MV-ICU and prevent VAP
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 |
|---|---|---|---|
| 1R01-DE-14685-1A2 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01DE014685 |
| R01DE014685 | NIH | None | None |