Effects of Oral Care in the Neuroscience ICU

Ventilator Associated Pneumonia Clinical Trial

Official title:

Comprehensive Oral Care for the Intubated Neuroscience ICU Patient: A Comparison of the Safety and Efficacy Between 2 Protocols

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00518752
• Other study ID #: 07NU018-1
• Status: Completed
• Phase: N/A
• First received: August 20, 2007
• Last updated: January 14, 2013
• Start date: May 2007
• Est. completion date: November 2011

Study information

• Verified date: January 2013
• Source: St. Joseph's Hospital and Medical Center, Phoenix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare how effective different ways of mouth cleaning are for patients in a neuroscience intensive care unit with a breathing tube in their mouth.

Description:

Patients with neurological dysfunction requiring intubation and ventilation are at risk for developing ventilator acquired pneumonia. Several studies have suggested that oral hygiene plays a role in the subsequent development of pneumonia for patients in the intensive care unit requiring intubation and mechanical ventilation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: November 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• > or equal 18 years old

• Intubated within 24hours of admission to the Neuroscience ICU

• Intubation anticipated to continue for approximately 72 hours

Exclusion Criteria:

• Minors

• Pregnancy

• Acute cervical spinal cord injury

• Severe facial trauma

• Family not present for consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Oral Hygiene
• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

Procedure:
• Standard Oral Care
Patients in this arm will receive standard oral care with manual brushes and routine oral hygiene products twice a day
• Comprehensive Oral Care
Patients will receive a comprehensive oral care protocol using mechanical brushes and oral care products formulated for patients with a dry mouth twice a day

Locations

Country	Name	City	State
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
St. Joseph's Hospital and Medical Center, Phoenix	Lund University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Dennesen P, van der Ven A, Vlasveld M, Lokker L, Ramsay G, Kessels A, van den Keijbus P, van Nieuw Amerongen A, Veerman E. Inadequate salivary flow and poor oral mucosal status in intubated intensive care unit patients. Crit Care Med. 2003 Mar;31(3):781-6. — 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of Ventilator Acquired Pneumonia		During the period of intubation	No
Secondary	Improved Oral Health		During the period of intubation and 48 hours following extubation	No