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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01498601
Enrollment
32
Registered
2011-12-23
Start date
2012-01-31
Completion date
2012-10-31
Last updated
2015-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia

Keywords

oral hygiene, tracheostomy, deglutition disorders, enteral nutrition, brain injury, coma

Brief summary

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.

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.

Interventions

OTHEREnhanced 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

Sponsors

Fraser Health
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Hospital Acquired Pneumonia Occurrences10 monthsHospital 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.

Countries

Canada

Participant flow

Recruitment details

The retrospective study group included care-dependent adults with a primary diagnosis of neurological injury/insult (n=51) meeting the inclusion criteria. Enrolled subjects in the prospective study received the experimental protocol (n=32).

Participants by arm

ArmCount
Oral Care Treatment Group
Subjects were neurologically impaired, dependent adults who met inclusion criteria. Subjects were identified upon admission to the in-patient unit during the study period.
32
Retrospective Study Group
Subjects were neurologically impaired, dependent adults who met inclusion criteria. Subjects were identified through a retrospective chart review for the same in-patient unit.
51
Total83

Baseline characteristics

CharacteristicOral Care Treatment GroupRetrospective Study GroupTotal
Age, Customized
Age >=19
32 participants51 participants83 participants
Region of Enrollment
Canada
32 participants51 participants83 participants
Sex: Female, Male
Female
9 Participants24 Participants33 Participants
Sex: Female, Male
Male
23 Participants27 Participants50 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 320 / 51
serious
Total, serious adverse events
2 / 3213 / 51

Outcome results

Primary

Hospital Acquired Pneumonia Occurrences

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.

Time frame: 10 months

ArmMeasureValue (NUMBER)
Oral Care Treatment GroupHospital Acquired Pneumonia Occurrences2 participants
Retrospective Study GroupHospital Acquired Pneumonia Occurrences13 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026