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

This study has been completed.
Information provided by (Responsible Party):
Fraser Health Identifier:
First received: December 13, 2011
Last updated: August 19, 2015
Last verified: December 2011
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.

Condition Intervention
Other: Enhanced oral care protocol

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Oral Care to Reduce Hospital Acquired Pneumonia (HAP) in the Acute, Non-Intubated, Care Dependent, Neurologically Impaired Adult Patient Population

Resource links provided by NLM:

Further study details as provided by Fraser Health:

Primary Outcome Measures:
  • Hospital Acquired Pneumonia Occurrences [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]
    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.

Enrollment: 32
Study Start Date: January 2012
Study Completion Date: October 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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.


Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01498601

Canada, British Columbia
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L 3W7
Sponsors and Collaborators
Fraser Health
Principal Investigator: Trudy L. Robertson, MSN Fraser Health Authority
Principal Investigator: Dulcie J. Carter, MMedSci Fraser Health Authority
  More Information

American Association of Critical Care Nurses. AACN Practice Alert: Oral Care for Patients at Risk for Ventilator-Associated Pneumonia. Retrieved April 10, 2011 from:
Yoon, M. & Steele, C. The oral care imperative: The link between oral hygiene and aspiration pneumonia. Topics in Geriatric Rehabilitation. 23(3), 280-288.
Perry & Potter. Fraser Health Nursing Skills for Mouth Care for the Unconscious or Debilitated Patient. Mosby's Nursing Skills: Clinical Nursing Skills & Techniques (7th Ed.). St. Louis. Retrieved April 14th, 2011 from:

Responsible Party: Fraser Health Identifier: NCT01498601     History of Changes
Other Study ID Numbers: FDAAA
Study First Received: December 13, 2011
Results First Received: March 30, 2015
Last Updated: August 19, 2015
Health Authority: Canada: Health Canada

Keywords provided by Fraser Health:
oral hygiene
deglutition disorders
enteral nutrition
brain injury

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections processed this record on November 27, 2015