Effects of Oral Care in the Neuroscience ICU

This study has been completed.
Lund University
Information provided by (Responsible Party):
St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier:
First received: August 20, 2007
Last updated: January 14, 2013
Last verified: January 2013

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 Intervention
Ventilator Associated Pneumonia
Oral Hygiene
Procedure: Standard Oral Care
Procedure: Comprehensive Oral Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by St. Joseph's Hospital and Medical Center, Phoenix:

Primary Outcome Measures:
  • Development of Ventilator Acquired Pneumonia [ Time Frame: During the period of intubation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improved Oral Health [ Time Frame: During the period of intubation and 48 hours following extubation ] [ Designated as safety issue: No ]

Enrollment: 113
Study Start Date: May 2007
Study Completion Date: November 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional 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
Study First Received: August 20, 2007
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 23, 2014