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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.
ClinicalTrials.gov 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

Brief Summary:
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.

Condition or disease Intervention/treatment
Ventilator Associated Pneumonia Oral Hygiene Procedure: Standard Oral Care Procedure: Comprehensive Oral Care

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comprehensive Oral Care for the Intubated Neuroscience ICU Patient: A Comparison of the Safety and Efficacy Between 2 Protocols
Study Start Date : May 2007
Primary Completion Date : March 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A
Standard Oral Care
Procedure: Standard Oral Care
Patients in this arm will receive standard oral care with manual brushes and routine oral hygiene products twice a day
Experimental: B
Comprehensive Oral Care
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

Primary Outcome Measures :
  1. Development of Ventilator Acquired Pneumonia [ Time Frame: During the period of intubation ]

Secondary Outcome Measures :
  1. Improved Oral Health [ Time Frame: During the period of intubation and 48 hours following extubation ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00518752

United States, Arizona
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Sponsors and Collaborators
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier: NCT00518752     History of Changes
Other Study ID Numbers: 07NU018-1
First Posted: August 21, 2007    Key Record Dates
Last Update Posted: January 16, 2013
Last Verified: January 2013

Keywords provided by St. Joseph's Hospital and Medical Center, Phoenix:
Ventilator Acquired Pneumonia
Oral Hygiene
Oral Care

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