Improving Oral Care to Reduce Hospital-Acquired Pneumonia (HAP) in the Acute Neurologically Impaired Adult

August 19, 2015 updated by: Fraser Health

Improving Oral Care to Reduce Hospital Acquired Pneumonia (HAP) in the Acute, Non-Intubated, Care Dependent, Neurologically Impaired Adult Patient Population

Hypothesis: The investigators hypothesize that the current oral protocol is sub-optimal and an enhanced protocol will decrease the incidence of hospital acquired pneumonia (HAP)in the acute, non-intubated, care-dependent, neurologically impaired, adult patient.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Overview Problem: Hospital-acquired pneumonia (HAP) is the second most common nosocomial infection and is a significant cause of morbidity and mortality. In the surgical population, HAP is associated with a 55% increase in length of stay and increased costs of approximately $31,000.00 per case. Neurologically impaired patients (those with brain injury causing alterations in mental status, immobility, impaired swallowing and cough, and increased risk of aspiration) are particularly vulnerable to HAP. HAP negatively impacts patient comfort and satisfaction, increases costs associated with diagnostic tests and treatments, increases risk for sepsis, and potential for higher level of care. It is estimated 95% of care-dependent patients on the Royal Columbian Hospital (RCH) neuroscience unit acquire HAP during their stay.

Gap: Research studies have shown improving oral hygiene in critical care, neuroscience intensive care units and cardiac surgery reduces the incidence of HAP. However, in the acutely ill neuroscience population outside critical care areas, this relationship has not been determined. Current oral care protocols, products and practitioner practice on medical/surgical units such as the RCH neuroscience unit do not consider recent evidence or recent increases in patient acuity and complexity.

Goal: The goal of this study is to test the efficacy of an improved, evidence-based oral care protocol in reducing HAP in this population on the medical/surgical neuroscience unit at RCH.

Research question: Does implementing an enhanced oral care protocol reduce rates of HAP in the acute, non-intubated, care-dependent, neurologically impaired, adult patient on a neuroscience unit?

Objective: To measure and compare the incidence of HAP among medical/surgical patients who had the current standard of oral care with those receiving an improved, preventative-based, oral hygiene protocol including regular teeth brushing, mouth and tongue inspection, swabbing and moisturizing, elevation of head of the bed (HOB), changing of suction equipment, and universal precautions.

Relevance: This study may identify the importance of standardizing oral hygiene protocols to the evidence, and heighten awareness among care providers in the prevention of HAP. If proven successful, the oral care protocol could be considered for implementation on acute units outside the RCH neuro unit.

Study Type

Interventional

Enrollment (Actual)

32

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

  • Canada
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W7
        • Royal Columbian Hospital

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult (> 19 years)
  • Admitted to RCH neuroscience unit
  • Primary diagnosis is neurological (brain injury/insult)
  • Non-intubated
  • Dependent for oral care and unable to direct their own oral care

Exclusion Criteria:

  • < 19 years
  • Off service patients
  • Intubated, on bilevel positive airway pressure or continuous positive airway pressure devices, (respiratory assistive devices)
  • Palliative
  • Capable of directing their own oral care
  • Unable to receive oral care due to: oral tubes, nasal/oral airways, wired jaws, or behaviours such as resistiveness, combativeness, non-compliance, etc.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral care treatment group
All subjects in the prospective intervention group will receive the same enhanced oral care protocol
Other: Enhanced oral care protocol
  • Changing mouth suction equipment every 24 hours
  • Mouth assessment every 2-4 hours
  • Cleansing mouth with toothbrush every 12 hours
  • Cleansing oral mucosa with oral rinse solution every 2-4 hours
  • Moisturize mouth/lips with swab and standard mouth moisturizer every 4 hours
  • Suction mouth and throat as needed
  • Head of the bed elevated to a minimum of 30° during oral care
Other Names:
  • Sage oral care products
No Intervention: Retrospective study group
For comparison purposes, a retrospective chart review of matched in-patient population will reveal pneumonia rates in the same population who did not receive the enhanced oral care protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Acquired Pneumonia Occurrences
Time Frame: 10 months
Hospital acquired pneumonia is acquired greater than 48 hours after admission and is diagnosed by a positive chest x-ray plus 2 of the following 3 symptoms: presence of fever, elevated serum white blood cells count, and positive sputum specimen.
10 months

Collaborators and Investigators

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

Sponsor

Fraser Health

Investigators

  • Principal Investigator: Trudy L. Robertson, MSN, Fraser Health Authority
  • Principal Investigator: Dulcie J. Carter, MMedSci, Fraser Health Authority

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

January 1, 2012

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

December 13, 2011

First Submitted That Met QC Criteria

December 22, 2011

First Posted (Estimate)

December 23, 2011

Study Record Updates

Last Update Posted (Estimate)

September 22, 2015

Last Update Submitted That Met QC Criteria

August 19, 2015

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDAAA

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.

Clinical Trials on Pneumonia

Clinical Trials on Enhanced oral care protocol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe