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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by HaEmek Medical Center, Israel.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00521677
First received: August 27, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  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:
  • Incidence of acquired pneumonia in ventilated patients in the ICU [ Time Frame: 30 days or as a long as patients on ventilator in the ICU ]

Secondary Outcome Measures:
  • 30 days all cause mortality, days off ventilator, LOS in ICU, LOS in hospital, use of antibiotics [ Time Frame: 30 days ]

Estimated Enrollment: 100
Study Start Date: September 2007
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
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

Contacts
Contact: Amiram Lev, MD +972-4-6494179 ext 4179 icuadm1@clalit.org.il
Contact: Tzipi Yakoby, RN, MA +972-4-6494080 ext 4080 tzipi_ya@clalit.org.il

Locations
Israel
General Intensive Care Unit, HaEmek MC Not yet recruiting
Afula, Israel, 18101
Contact: Tzipi Yakoby, RN MA    +972-4-6494080 ext 4080    tzipi_ya@clalit.org.il   
Contact: Amiram Lev, MD    +972-4-6494179 ext 4179    icuadm1@clalit.org.il   
Principal Investigator: Amiram Lev, MD         
Sub-Investigator: Tzipi Yakoby, RN, MA         
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

No publications provided

ClinicalTrials.gov Identifier: NCT00521677     History of Changes
Other Study ID Numbers: VAP1
Study First Received: August 27, 2007
Last Updated: August 27, 2007
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
Cross Infection
Infection
Lung Diseases
Lung Injury
Respiratory Tract Diseases
Respiratory Tract Infections
Ventilator-Induced Lung Injury

ClinicalTrials.gov processed this record on November 20, 2014