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CompletedNCT00518752Updated Jan 16, 2013

Effects of Oral Care in the Neuroscience ICU

An interventional study of Standard Oral Care and Comprehensive Oral Care in Ventilator Associated Pneumonia and Oral Hygiene, sponsored by St. Joseph's Hospital and Medical Center, Phoenix. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-16.

Sponsored by St. Joseph's Hospital and Medical Center, Phoenix · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
113
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Ventilator Associated Pneumonia
  • Oral Hygiene

Keywords

  • Ventilator Acquired Pneumonia
  • Oral Hygiene
  • Oral Care
  • Xerostomia
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In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 113 is close to the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

St. Joseph's Hospital and Medical Center, Phoenix is the lead sponsor of 63 studies on the registry; 11 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Minors
  • Pregnancy
  • Acute cervical spinal cord injury
  • Severe facial trauma
  • Family not present for consent
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
113 participants (actual)

Study arms

  • Active comparator
    A

    Standard Oral Care

    Procedure: Standard Oral Care

  • Experimental
    B

    Comprehensive Oral Care

    Procedure: Comprehensive Oral Care

Interventions

  • ProcedureStandard Oral Care

    Patients in this arm will receive standard oral care with manual brushes and routine oral hygiene products twice a day

  • ProcedureComprehensive 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

06

What researchers measure

Primary outcomes

  1. Development of Ventilator Acquired Pneumonia

    Time frame: During the period of intubation

Secondary outcomes

  1. Improved Oral Health

    Time frame: During the period of intubation and 48 hours following extubation

07

Study locations

1 site
  • St. Joseph's Hospital and Medical Center
    Phoenix, Arizona 85013, United States
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References and documents

Publications

  • 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. PubMed 14735645 ↗
  • 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. doi: 10.1097/01.CCM.0000053646.04085.29. PubMed 12626984 ↗
  • Prendergast 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. PubMed 21249529 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00518752
Lead sponsor
St. Joseph's Hospital and Medical Center, Phoenix
Collaborators
Lund University
Responsible party
Sponsor
First posted
Aug 21, 2007
Start date
May 2007
Primary completion
Mar 2011
Completion
Nov 2011
Last update
Jan 16, 2013

Study contacts

Virginia C Prendergast, MSN, NP-C
principal investigator · St Joseph's Hospital and Medical Center, Phoenix, Arizona, USA
Ingalill R Hallberg, PhD
study chair · Vardalinstitutet, University of Lund, Sweden

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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