Effects of Oral Care in the Neuroscience ICU
Comprehensive Oral Care for the Intubated Neuroscience ICU Patient: A Comparison of the Safety and Efficacy Between 2 Protocols
1 other identifier
interventional
113
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 20, 2007
CompletedFirst Posted
Study publicly available on registry
August 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedJanuary 16, 2013
January 1, 2013
3.8 years
August 20, 2007
January 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Development of Ventilator Acquired Pneumonia
During the period of intubation
Secondary Outcomes (1)
Improved Oral Health
During the period of intubation and 48 hours following extubation
Study Arms (2)
A
ACTIVE COMPARATORStandard Oral Care
B
EXPERIMENTALComprehensive Oral Care
Interventions
Patients in this arm will receive standard oral care with manual brushes and routine oral hygiene products twice a day
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
Eligibility Criteria
You may qualify if:
- \> or equal 18 years old
- Intubated within 24hours of admission to the Neuroscience ICU
- Intubation anticipated to continue for approximately 72 hours
You may not qualify if:
- Minors
- Pregnancy
- Acute cervical spinal cord injury
- Severe facial trauma
- Family not present for consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. Joseph's Hospital and Medical Center, Phoenixlead
- Lund Universitycollaborator
Study Sites (1)
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Related Publications (3)
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: 14735645BACKGROUNDDennesen 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. doi: 10.1097/01.CCM.0000053646.04085.29.
PMID: 12626984BACKGROUNDPrendergast V, Hagell P, Hallberg IR. Electric versus manual tooth brushing among neuroscience ICU patients: is it safe? Neurocrit Care. 2011 Apr;14(2):281-6. doi: 10.1007/s12028-011-9502-2.
PMID: 21249529DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Virginia C Prendergast, MSN, NP-C
St Joseph's Hospital and Medical Center, Phoenix, Arizona, USA
- STUDY CHAIR
Ingalill R Hallberg, PhD
Vardalinstitutet, University of Lund, Sweden
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2007
First Posted
August 21, 2007
Study Start
May 1, 2007
Primary Completion
March 1, 2011
Study Completion
November 1, 2011
Last Updated
January 16, 2013
Record last verified: 2013-01