Comparison Between Two Methods of Oral Care on the Incide... | NCT00521677

Studies
Comparison Between Two Methods of Oral Care on the Incidence of VAP

NCT00521677

Sponsor

HaEmek Medical Center, Israel

Status

Completed

Last Update Posted

Jun 23, 2015Estimated

Enrollment

108Actual

Phase

Not Applicable

Conditions

Pneumonia, Ventilator-Associated

Interventions

Sage oral care
Traditional oral care

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Feb 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Aug 27, 2007

First Submission Date that Met QC Criteria

Aug 27, 2007

First Posted Date

Aug 28, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2015

Last Update Posted Date

Jun 23, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 y/o, 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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

108Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Procedure: 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.	Procedure: Sage oral care
2	Active Comparator	The traditional method of oral care with cleaning of the oral cavity with a sponge soaked with antiseptic non alcoholic solution	Procedure: Traditional oral care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sage oral care	Procedure	Oral care include teeth brush and oral cavity cleaning with a non alcoholic solution, TID	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The influence of oral care, including teeth brush and oral cavity cleaning with non alcoholic solution in ventilated ICU patients, on the incidence of VAP		30 days

Secondary Outcomes

Measure	Description	Time Frame
30 days all cause mortality, days off ventilator, LOS in ICU, LOS in hospital, use of antibiotics		30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All ventilated patients in the ICU
Older than 18 y/o

Exclusion Criteria:

Age less than 18 years
Pregnancy
Immunosuperessed patients
Expected survival of less than 48 hours
Burns
Existing pneumonia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amiram Lev, MD	HaEmek MC	Principal Investigator
Tzipi Yakoby, RN, MA	HaEmek MC	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
General Intensive Care Unit, HaEmek MC		Afula		18101	Israel

Condition Browse Module

MeSH Terms

ID	Term
D053717	Pneumonia, Ventilator-Associated

Ancestor Terms

ID	Term
D000077299	Healthcare-Associated Pneumonia
D003428	Cross Infection
D007239	Infections
D011014	Pneumonia

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Browse Branches

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