Effects of Oral Care in the Neuroscience ICU

January 14, 2013 updated by: St. Joseph's Hospital and Medical Center, Phoenix

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

113

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Development of Ventilator Acquired Pneumonia
Time Frame: During the period of intubation
During the period of intubation

Secondary Outcome Measures

Outcome Measure
Time Frame
Improved Oral Health
Time Frame: During the period of intubation and 48 hours following extubation
During the period of intubation and 48 hours following extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

August 20, 2007

First Submitted That Met QC Criteria

August 20, 2007

First Posted (Estimate)

August 21, 2007

Study Record Updates

Last Update Posted (Estimate)

January 16, 2013

Last Update Submitted That Met QC Criteria

January 14, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07NU018-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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