Ventilator Associated PneumoniaNCT00518752
Effects of Oral Care in the Neuroscience ICU
A study testing Standard Oral Care and Comprehensive Oral Care in people with Ventilator Associated Pneumonia and Oral Hygiene, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia, Oral Hygiene
- What is being tested?
- Standard Oral Care and Comprehensive Oral Care
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > or equal 18 years old
- Intubated within 24hours of admission to the Neuroscience ICU
- Intubation anticipated to continue for approximately 72 hours
Who cannot join
- Minors
- Pregnancy
- Acute cervical spinal cord injury
- Severe facial trauma
- Family not present for consent
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
About this study
Official title: Comprehensive Oral Care for the Intubated Neuroscience ICU Patient: A Comparison of the Safety and Efficacy Between 2 Protocols
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.
- Conditions
- Ventilator Associated Pneumonia, Oral Hygiene
- Being tested
- Standard Oral Care, Comprehensive Oral Care
- Keywords
- Ventilator Acquired Pneumonia, Oral Hygiene, Oral Care, Xerostomia
- Medical subject headings
- Pneumonia, Ventilator-Associated, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Oral CareProcedure or surgery
Patients in this arm will receive standard oral care with manual brushes and routine oral hygiene products twice a day
Comprehensive Oral CareProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Standard Oral Care Receives: Procedure: Standard Oral Care |
| B | Experimental | Comprehensive Oral Care Receives: Procedure: Comprehensive Oral Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Ventilator Acquired Pneumonia
Measured: During the period of intubation
Secondary outcomes (1)
Improved Oral Health
Measured: During the period of intubation and 48 hours following extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2007 (estimated)
- Study startMay 2007
- Primary completionMar 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Sponsor
- Investigators
- Virginia C Prendergast, MSN, NP-C, Principal investigator, St Joseph's Hospital and Medical Center, Phoenix, Arizona, USAIngalill R Hallberg, PhD, Study chair, Vardalinstitutet, University of Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518752
- Sponsor's protocol ID
- 07NU018-1
- Status last verified
- Jan 2013
- First submitted
- 20 Aug 2007
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
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 14735645Dennesen 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 12626984Prendergast 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Oral Care for the Intubated Neuroscience ICU Patient: A Comparison of the Safety and Efficacy Between 2 Protocols
- ClinicalTrials.gov ID
- NCT00518752
- Acronym / sponsor ID
- 07NU018-1
- Conditions
- Ventilator Associated Pneumonia, Oral Hygiene
- Keywords
- Ventilator Acquired Pneumonia, Oral Hygiene, Oral Care, Xerostomia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- St. Joseph's Hospital and Medical Center, PhoenixUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- May 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 21 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: Standard Oral CareStandard Oral Care |
| B | Experimental | Procedure: Comprehensive Oral CareComprehensive Oral Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- > or equal 18 years old
- Intubated within 24hours of admission to the Neuroscience ICU
- Intubation anticipated to continue for approximately 72 hours
Key exclusion criteria (5 listed)
- Minors
- Pregnancy
- Acute cervical spinal cord injury
- Severe facial trauma
- Family not present for consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Oral CarePatients in this arm will receive standard oral care with manual brushes and routine oral hygiene products twice a day | Procedure or surgery | A |
| Comprehensive Oral CarePatients will receive a comprehensive oral care protocol using mechanical brushes and oral care products formulated for patients with a dry mouth twice a day | Procedure or surgery | B |
Primary outcome
Development of Ventilator Acquired Pneumonia
Time frame: During the period of intubation
1 secondary outcome
Improved Oral Health
Time frame: During the period of intubation and 48 hours following extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
- Background: PubMed 14735645Munro 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.
- Background: PubMed 12626984Dennesen 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.
- Derived from this study: PubMed 21249529Prendergast 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Oral Care and Comprehensive Oral Care in people with Ventilator Associated Pneumonia and Oral Hygiene, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of Ventilator Acquired Pneumonia (time frame: During the period of intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00518752, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2013.