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

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01498601
• Other study ID #: FDAAA
• Status: Completed
• Phase: N/A
• First received: December 13, 2011
• Last updated: August 19, 2015
• Start date: January 2012
• Est. completion date: October 2012

Study information

• Verified date: December 2011
• Source: Fraser Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia

Intervention

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

Locations

Country	Name	City	State
Canada	Royal Columbian Hospital	New Westminster	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Fraser Health

Country where clinical trial is conducted

Canada, 

References & Publications (24)

American Association of Critical Care Nurses. AACN Practice Alert: Oral Care for Patients at Risk for Ventilator-Associated Pneumonia. Retrieved April 10, 2011 from: http://www.aacn.org

Bopp M, Darby M, Loftin KC, Broscious S. Effects of daily oral care with 0.12% chlorhexidine gluconate and a standard oral care protocol on the development of nosocomial pneumonia in intubated patients: a pilot study. J Dent Hyg. 2006 Summer;80(3):9. Epub — View Citation

Chan EY, Ruest A, Meade MO, Cook DJ. Oral decontamination for prevention of pneumonia in mechanically ventilated adults: systematic review and meta-analysis. BMJ. 2007 Apr 28;334(7599):889. Epub 2007 Mar 26. Review. — View Citation

Cohn JL, Fulton JS. Nursing staff perspectives on oral care for neuroscience patients. J Neurosci Nurs. 2006 Feb;38(1):22-30. — View Citation

DeRiso AJ 2nd, Ladowski JS, Dillon TA, Justice JW, Peterson AC. Chlorhexidine gluconate 0.12% oral rinse reduces the incidence of total nosocomial respiratory infection and nonprophylactic systemic antibiotic use in patients undergoing heart surgery. Ches — View Citation

Fields LB. Oral care intervention to reduce incidence of ventilator-associated pneumonia in the neurologic intensive care unit. J Neurosci Nurs. 2008 Oct;40(5):291-8. — View Citation

Grap MJ, Munro CL, Ashtiani B, Bryant S. Oral care interventions in critical care: frequency and documentation. Am J Crit Care. 2003 Mar;12(2):113-8; discussion 119. — View Citation

Hilker R, Poetter C, Findeisen N, Sobesky J, Jacobs A, Neveling M, Heiss WD. Nosocomial pneumonia after acute stroke: implications for neurological intensive care medicine. Stroke. 2003 Apr;34(4):975-81. Epub 2003 Mar 13. — View Citation

Houston S, Hougland P, Anderson JJ, LaRocco M, Kennedy V, Gentry LO. Effectiveness of 0.12% chlorhexidine gluconate oral rinse in reducing prevalence of nosocomial pneumonia in patients undergoing heart surgery. Am J Crit Care. 2002 Nov;11(6):567-70. — View Citation

Langmore SE, Terpenning MS, Schork A, Chen Y, Murray JT, Lopatin D, Loesche WJ. Predictors of aspiration pneumonia: how important is dysphagia? Dysphagia. 1998 Spring;13(2):69-81. — View Citation

Marik PE, Kaplan D. Aspiration pneumonia and dysphagia in the elderly. Chest. 2003 Jul;124(1):328-36. Review. — View Citation

Marik PE. Aspiration pneumonitis and aspiration pneumonia. N Engl J Med. 2001 Mar 1;344(9):665-71. Review. — View Citation

Munro CL, Grap MJ. Oral health and care in the intensive care unit: state of the science. Am J Crit Care. 2004 Jan;13(1):25-33; discussion 34. Review. — View Citation

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: http://app44.webinservice.com/NursingSkills/ContentPlayer/SkillContentPlayerIFrame.aspx?KeyId=598&Id=GN_14_3&Section=1&bcp=Index~M~False&IsConnect=False

Prendergast V, Hallberg IR, Jahnke H, Kleiman C, Hagell P. Oral health, ventilator-associated pneumonia, and intracranial pressure in intubated patients in a neuroscience intensive care unit. Am J Crit Care. 2009 Jul;18(4):368-76. doi: 10.4037/ajcc2009621 — View Citation

Reimer-Kent J. From theory to practice: preventing pain after cardiac surgery. Am J Crit Care. 2003 Mar;12(2):136-43. — View Citation

Rotstein C, Evans G, Born A, Grossman R, Light RB, Magder S, McTaggart B, Weiss K, Zhanel GG. Clinical practice guidelines for hospital-acquired pneumonia and ventilator-associated pneumonia in adults. Can J Infect Dis Med Microbiol. 2008 Jan;19(1):19-53. — View Citation

Safdar N, Crnich CJ, Maki DG. The pathogenesis of ventilator-associated pneumonia: its relevance to developing effective strategies for prevention. Respir Care. 2005 Jun;50(6):725-39; discussion 739-41. Review. — View Citation

Shi Z, Xie H, Wang P, Zhang Q, Wu Y, Chen E, Ng L, Worthington HV, Needleman I, Furness S. Oral hygiene care for critically ill patients to prevent ventilator-associated pneumonia. Cochrane Database Syst Rev. 2013 Aug 13;8:CD008367. doi: 10.1002/14651858. — View Citation

Shigemitsu H, Afshar K. Aspiration pneumonias: under-diagnosed and under-treated. Curr Opin Pulm Med. 2007 May;13(3):192-8. Review. — View Citation

Shorr AF, Kollef MH. Ventilator-associated pneumonia: insights from recent clinical trials. Chest. 2005 Nov;128(5 Suppl 2):583S-591S. — View Citation

Terpenning MS, Taylor GW, Lopatin DE, Kerr CK, Dominguez BL, Loesche WJ. Aspiration pneumonia: dental and oral risk factors in an older veteran population. J Am Geriatr Soc. 2001 May;49(5):557-63. — View Citation

Thompson DA, Makary MA, Dorman T, Pronovost PJ. Clinical and economic outcomes of hospital acquired pneumonia in intra-abdominal surgery patients. Ann Surg. 2006 Apr;243(4):547-52. — View Citation

Yoon, M. & Steele, C. The oral care imperative: The link between oral hygiene and aspiration pneumonia. Topics in Geriatric Rehabilitation. 23(3), 280-288.

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	10 months	Yes