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

NCT01498601 | Completed Results

• 1 other identifier: FDAAA
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Oral care treatment group

EXPERIMENTAL

All subjects in the prospective intervention group will receive the same enhanced oral care protocol

Other: Enhanced oral care protocol

Retrospective study group

NO INTERVENTION

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.

Interventions

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

Also known as: Sage oral care products

Oral care treatment group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \< 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.

Sponsors & Collaborators

• Fraser Health: lead

Study Sites (1)

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

Related Publications (24)

• Marik PE. Aspiration pneumonitis and aspiration pneumonia. N Engl J Med. 2001 Mar 1;344(9):665-71. doi: 10.1056/NEJM200103013440908. No abstract available.

  PMID: 11228282 BACKGROUND

• Marik PE, Kaplan D. Aspiration pneumonia and dysphagia in the elderly. Chest. 2003 Jul;124(1):328-36. doi: 10.1378/chest.124.1.328.

  PMID: 12853541 BACKGROUND

• 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.

  PMID: 14735645 BACKGROUND

• 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

  BACKGROUND

• Shigemitsu H, Afshar K. Aspiration pneumonias: under-diagnosed and under-treated. Curr Opin Pulm Med. 2007 May;13(3):192-8. doi: 10.1097/MCP.0b013e3280f629f0.

  PMID: 17414126 BACKGROUND

• 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. doi: 10.1046/j.1532-5415.2001.49113.x.

  PMID: 11380747 BACKGROUND

• 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

  RESULT

• 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 2006 Jul 1.

  PMID: 16953990 RESULT

• 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. doi: 10.1136/bmj.39136.528160.BE. Epub 2007 Mar 26.

  PMID: 17387118 RESULT

• Cohn JL, Fulton JS. Nursing staff perspectives on oral care for neuroscience patients. J Neurosci Nurs. 2006 Feb;38(1):22-30. doi: 10.1097/01376517-200602000-00006.

  PMID: 16568810 RESULT

• 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. Chest. 1996 Jun;109(6):1556-61. doi: 10.1378/chest.109.6.1556.

  PMID: 8769511 RESULT

• 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. doi: 10.1097/01376517-200810000-00007.

  PMID: 18856250 RESULT

• 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.

  PMID: 12625169 RESULT

• 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. doi: 10.1161/01.STR.0000063373.70993.CD. Epub 2003 Mar 13.

  PMID: 12637700 RESULT

• 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.

  PMID: 12425407 RESULT

• 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. doi: 10.1007/PL00009559.

  PMID: 9513300 RESULT

• 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.

  PMID: 19556415 RESULT

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

  PMID: 12625171 RESULT

• 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. doi: 10.1155/2008/593289.

  PMID: 19145262 RESULT

• 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.

  PMID: 15913465 RESULT

• Shorr AF, Kollef MH. Ventilator-associated pneumonia: insights from recent clinical trials. Chest. 2005 Nov;128(5 Suppl 2):583S-591S. doi: 10.1378/chest.128.5_suppl_2.583S.

  PMID: 16306057 RESULT

• 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. doi: 10.1097/01.sla.0000207097.38963.3b.

  PMID: 16552208 RESULT

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

  RESULT

• 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.CD008367.pub2.

  PMID: 23939759 RESULT

MeSH Terms

Conditions

Pneumonia; Deglutition Disorders; Brain Injuries; Coma

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This study was supported by the Fraser Health Point of Care Research Challenge.

Results Point of Contact

• Title: Trudy Robertson RN, MSN, CNN(c)
• Organization: Fraser Health

Trudy.Robertson@fraserhealth.ca

604-520-4715

Study Officials

• Trudy L. Robertson, MSN

  Fraser Health Authority

  PRINCIPAL INVESTIGATOR

• Dulcie J. Carter, MMedSci

  Fraser Health Authority

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: December 23, 2011
• Study Start: January 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: October 1, 2012
• Last Updated: September 22, 2015
• Results First Posted: September 22, 2015

Record last verified: 2011-12

Locations

CA (1)