Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00521677
Status:
COMPLETED
Last Update Posted:
2015-06-23
First Post:
2007-08-27
Brief Title:
Comparison Between Two Methods of Oral Care on the Incidence of VAP
Sponsor:
HaEmek Medical Center Israel
Organization:
HaEmek Medical Center Israel
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2015-06
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:
Patients on ventilator are in high risk to develop ventilator associated pneumonia VAP This acquired infection significantly increases morbidity and mortality of these patients
Studies that investigated the factors influencing the incidence of VAP proved that infectious agents located in the throat and oral cavity are important factors
The assimilation of oral cavity treatment including teeth brushing cleaning and removal of secretions may significantly decrease the incidence of VAP Choosing the method of oral cavity cleaning is based on few studies that demonstrated the optimal influence of combining mechanical cleansing the use of a non alcoholic antiseptic material and lubrication of the lips and the oral cavity Most of these studies are retrospective The study will compare the traditional method of oral cavity treatment with the use of protocol that use special suction connected toothbrush to clean the teeth and the oral cavity use of non alcoholic antiseptic solution and lubrication of the lips and the oral cavity
The current study is a prospective open label statistically balanced study that will investigate the connection between the method of oral cavity treatment and the incidence of VAP 100 patients will be included
All ventilated patients in the ICU will be eligible and will be included after an informed consent will be signed by the patient or by his legal guardian Exclusion criteria include age less than 18 yo pregnancy expected survival of less than 48 hours immunosupression excluding patients on steroids severe burns existing pneumonia and patient already included in another study
The main outcome will be 30 days all cause mortality Secondary outcomes include the development of VAP days on ventilator LOS in the ICU and LOS in the hospital
Studies that investigated the factors influencing the incidence of VAP proved that infectious agents located in the throat and oral cavity are important factors
The assimilation of oral cavity treatment including teeth brushing cleaning and removal of secretions may significantly decrease the incidence of VAP Choosing the method of oral cavity cleaning is based on few studies that demonstrated the optimal influence of combining mechanical cleansing the use of a non alcoholic antiseptic material and lubrication of the lips and the oral cavity Most of these studies are retrospective The study will compare the traditional method of oral cavity treatment with the use of protocol that use special suction connected toothbrush to clean the teeth and the oral cavity use of non alcoholic antiseptic solution and lubrication of the lips and the oral cavity
The current study is a prospective open label statistically balanced study that will investigate the connection between the method of oral cavity treatment and the incidence of VAP 100 patients will be included
All ventilated patients in the ICU will be eligible and will be included after an informed consent will be signed by the patient or by his legal guardian Exclusion criteria include age less than 18 yo pregnancy expected survival of less than 48 hours immunosupression excluding patients on steroids severe burns existing pneumonia and patient already included in another study
The main outcome will be 30 days all cause mortality Secondary outcomes include the development of VAP days on ventilator LOS in the ICU and LOS in the hospital
Detailed Description:
None
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