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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00521677
First received: August 27, 2007
Last updated: June 21, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention
Pneumonia, Ventilator-Associated
Procedure: Sage oral care
Procedure: Traditional oral care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • 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 [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 30 days all cause mortality, days off ventilator, LOS in ICU, LOS in hospital, use of antibiotics [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 108
Study Start Date: September 2007
Study Completion Date: October 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Oral care include teeth brush and oral cavity cleaning with a non alcoholic solution, TID
Active Comparator: 2
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
Cleaning of oral cavity with menthol solution, TID
Other Name: Tarodent

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00521677

Locations
Israel
General Intensive Care Unit, HaEmek MC
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Amiram Lev, MD HaEmek MC
Study Director: Tzipi Yakoby, RN, MA HaEmek MC
  More Information

Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT00521677     History of Changes
Other Study ID Numbers: VAP1 
Study First Received: August 27, 2007
Last Updated: June 21, 2015
Health Authority: Israel: Ministry of Health

Keywords provided by HaEmek Medical Center, Israel:
VAP
Oral care
Acquired pneumonia
Mortality
LOS in ICU
LOS in hospital
All patients on ventilator in the ICU

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury

ClinicalTrials.gov processed this record on July 21, 2016