Effects of Oral Care in the Neuroscience ICU

This study has been completed.
Sponsor:
Collaborator:
Lund University
Information provided by (Responsible Party):
St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier:
NCT00518752
First received: August 20, 2007
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

Locations
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
Investigators
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

Publications:
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
Xerostomia

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 April 17, 2014