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Effects of Oral Care in the Neuroscience ICU

Primary Purpose

Ventilator Associated Pneumonia, Oral Hygiene

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Oral Care
Comprehensive Oral Care
Sponsored by
St. Joseph's Hospital and Medical Center, Phoenix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventilator Associated Pneumonia focused on measuring Ventilator Acquired Pneumonia, Oral Hygiene, Oral Care, Xerostomia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Hospital and Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A

B

Arm Description

Standard Oral Care

Comprehensive Oral Care

Outcomes

Primary Outcome Measures

Development of Ventilator Acquired Pneumonia

Secondary Outcome Measures

Improved Oral Health

Full Information

First Posted
August 20, 2007
Last Updated
January 14, 2013
Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
Collaborators
Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT00518752
Brief Title
Effects of Oral Care in the Neuroscience ICU
Official Title
Comprehensive Oral Care for the Intubated Neuroscience ICU Patient: A Comparison of the Safety and Efficacy Between 2 Protocols
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
Collaborators
Lund University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Associated Pneumonia, Oral Hygiene
Keywords
Ventilator Acquired Pneumonia, Oral Hygiene, Oral Care, Xerostomia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Standard Oral Care
Arm Title
B
Arm Type
Experimental
Arm Description
Comprehensive Oral Care
Intervention Type
Procedure
Intervention Name(s)
Standard Oral Care
Intervention Description
Patients in this arm will receive standard oral care with manual brushes and routine oral hygiene products twice a day
Intervention Type
Procedure
Intervention Name(s)
Comprehensive Oral Care
Intervention Description
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 Measure Information:
Title
Development of Ventilator Acquired Pneumonia
Time Frame
During the period of intubation
Secondary Outcome Measure Information:
Title
Improved Oral Health
Time Frame
During the period of intubation and 48 hours following extubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginia C Prendergast, MSN, NP-C
Organizational Affiliation
St Joseph's Hospital and Medical Center, Phoenix, Arizona, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ingalill R Hallberg, PhD
Organizational Affiliation
Vardalinstitutet, University of Lund, Sweden
Official's Role
Study Chair
Facility Information:
Facility Name
St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
14735645
Citation
Munro CL, Grap MJ. Oral health and care in the intensive care unit: state of the science. Am J Crit Care. 2004 Jan;13(1):25-33; discussion 34.
Results Reference
background
PubMed Identifier
12626984
Citation
Dennesen P, van der Ven A, Vlasveld M, Lokker L, Ramsay G, Kessels A, van den Keijbus P, van Nieuw Amerongen A, Veerman E. Inadequate salivary flow and poor oral mucosal status in intubated intensive care unit patients. Crit Care Med. 2003 Mar;31(3):781-6. doi: 10.1097/01.CCM.0000053646.04085.29.
Results Reference
background
PubMed Identifier
21249529
Citation
Prendergast V, Hagell P, Hallberg IR. Electric versus manual tooth brushing among neuroscience ICU patients: is it safe? Neurocrit Care. 2011 Apr;14(2):281-6. doi: 10.1007/s12028-011-9502-2.
Results Reference
derived

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Effects of Oral Care in the Neuroscience ICU

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