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Completed

NCT Number: NCT01498601

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enhanced oral care protocol

Other
  • 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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Fraser Health

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Dec 23, 2011
Registry last updated
Sep 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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