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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01NR007652-10A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
| Tampa General Hospital | OTHER |
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Tooth brushing for patients with breathing tubes is routinely provided by the bedside nurse as part of clinical care. The purpose of this study is to determine how often tooth brushing should occur for adult patients with breathing tubes (mechanical ventilation), balanced with equivalence and safety.
A total of 345 adult subjects who are intubated and require mechanical ventilation will be randomly assigned to one of the three different tooth brushing frequency groups: once a day, twice a day or three times a day, up to a maximum of seven days. Teeth will be brushed with a soft child size toothbrush will take approximately 2 minutes. Following tooth brushing, the mouth will be rinsed with alcohol-free mouthwash and oral fluids will be removed with an oral suction tip. Moisturizing gel will be gently applied. The complete intervention requires approximately 15 minutes.
Information will be collected will include clinical condition, medications, age, gender, and smoking status. Once every day, digital pictures will be taken of each tooth (takes approximately five minutes) using a small intraoral camera to be evaluated for plaque by a dental hygienist that is blinded to frequency group assignment. Once every day, gingival crevicular fluid samples (takes 30 seconds) to look for factors that predict infection.
Gingival crevicular fluid samples and digital pictures of the teeth will also be collected on day 1, day 3 and day 5 after extubation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Frequency of Once a Day | Experimental | Tooth Brushing Protocol to be provided at 8:00 am (+/- 1.5 hours) |
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| Frequency of Twice a Day | Experimental | Tooth Brushing Protocol to be provided at 8:00 am (+/- 1.5 hours) Tooth Brushing Protocol to be provided at 1:00 pm (+/- 1.5 hours) |
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| Frequency of Three Times a Day | Experimental | Tooth Brushing Protocol to be provided at 8:00 am (+/- 1.5 hours) Tooth Brushing Protocol to be provided at 1:00 pm (+/- 1.5 hours) Tooth Brushing Protocol to be provided at 6:00 pm (+/- 1.5 hours) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tooth Brushing Protocol | Procedure | A 2-minute tooth brushing protocol, followed by a mouthwash rinse and application of moisturizer for a total of approximately 15 minutes. |
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| Measure | Description | Time Frame |
|---|---|---|
| Dental Plaque as measured by University of Mississippi Oral Hygiene Index | University of Mississippi Oral Hygiene Index | Participants will be followed for the duration of the study, an expected average of 10 days. |
| Gingival Inflammation as measured by Gingival Crevicular Fluid Samples | Gingival Crevicular Fluid Samples | Participants will be followed for the duration of the study, an expected average of 10 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic Inflammatory Response Syndrome as measured by SIRS Criteria | SIRS Criteria | Participants will be followed for the duration of the study, an expected average of 10 days. |
| Hospital Acquired Infection as measured by positive epidemiologic surveillance report for VAE (including VAP), bacteremia, sepsis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cindy L Munro, PhD | University of Miami | Principal Investigator |
| Kevin E Kip, PhD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 11, 2017 | Oct 30, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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positive epidemiologic surveillance report for Ventilator Associated Event (including VAP), bacteremia, sepsis |
| Participants will be followed for the duration of the study, an expected average of 10 days. |
| Length of Hospital Stay | Number of days from hospital admission date to hospital discharge date | Participants will be followed for the duration of hospital stay, an expected average of 10 days. |
| Length of Intubation | Number of days from intubation date to extubation date | Participants will be followed for the duration of the study, an expected average of 10 days. |