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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Fraser Health.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Fraser Health
ClinicalTrials.gov Identifier:
NCT01498601
First received: December 13, 2011
Last updated: December 22, 2011
Last verified: December 2011
  Purpose

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
Pneumonia
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.


Estimated Enrollment: 35
Study Start Date: January 2012
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: June 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 chart review
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.

  Eligibility

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

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 (Bipap) or continuous positive airway pressure (CPAP) 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01498601

Contacts
Contact: Trudy L. Robertson, MSN (604) 520-4715 Trudy.Robertson@fraserhealth.ca
Contact: Dulcie J. Carter, MMedSci (604) 520-4510 Dulcie.Carter@fraserhealth.ca

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

Publications:

Responsible Party: Fraser Health
ClinicalTrials.gov Identifier: NCT01498601     History of Changes
Other Study ID Numbers: FDAAA
Study First Received: December 13, 2011
Last Updated: December 22, 2011
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on July 24, 2014