Effects of Oral Care in the Neuroscience ICU

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00518752
Recruitment Status : Completed
First Posted : August 21, 2007
Last Update Posted : January 16, 2013
Lund University
Information provided by (Responsible Party):
St. Joseph's Hospital and Medical Center, Phoenix

August 20, 2007
August 21, 2007
January 16, 2013
May 2007
March 2011   (Final data collection date for primary outcome measure)
Development of Ventilator Acquired Pneumonia [ Time Frame: During the period of intubation ]
Same as current
Complete list of historical versions of study NCT00518752 on Archive Site
Improved Oral Health [ Time Frame: During the period of intubation and 48 hours following extubation ]
Same as current
Not Provided
Not Provided
Effects of Oral Care in the Neuroscience ICU
Comprehensive Oral Care for the Intubated Neuroscience ICU Patient: A Comparison of the Safety and Efficacy Between 2 Protocols
The purpose of this study is to compare how effective different ways of mouth cleaning are for patients in a neuroscience intensive care unit with a breathing tube in their mouth.
Patients with neurological dysfunction requiring intubation and ventilation are at risk for developing ventilator acquired pneumonia. Several studies have suggested that oral hygiene plays a role in the subsequent development of pneumonia for patients in the intensive care unit requiring intubation and mechanical ventilation.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Ventilator Associated Pneumonia
  • Oral Hygiene
  • Procedure: Standard Oral Care
    Patients in this arm will receive standard oral care with manual brushes and routine oral hygiene products twice a day
  • Procedure: Comprehensive Oral Care
    Patients will receive a comprehensive oral care protocol using mechanical brushes and oral care products formulated for patients with a dry mouth twice a day
  • Active Comparator: A
    Standard Oral Care
    Intervention: Procedure: Standard Oral Care
  • Experimental: B
    Comprehensive Oral Care
    Intervention: Procedure: Comprehensive Oral Care

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2011
March 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • > or equal 18 years old
  • Intubated within 24hours of admission to the Neuroscience ICU
  • Intubation anticipated to continue for approximately 72 hours

Exclusion Criteria:

  • Minors
  • Pregnancy
  • Acute cervical spinal cord injury
  • Severe facial trauma
  • Family not present for consent
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
St. Joseph's Hospital and Medical Center, Phoenix
St. Joseph's Hospital and Medical Center, Phoenix
Lund University
Principal Investigator: Virginia C Prendergast, MSN, NP-C St Joseph's Hospital and Medical Center, Phoenix, Arizona, USA
Study Chair: Ingalill R Hallberg, PhD Vardalinstitutet, University of Lund, Sweden
St. Joseph's Hospital and Medical Center, Phoenix
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP