Frequency of Oral Care Intervention Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Oral Care Intervention In Mechanically Ventilated Adults: Renewal

Conditions
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Respiratory Failure

Intervention / Treatment
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* Procedure: Tooth Brushing Protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: within 36 hours of initial intubation, have at least one tooth, and they or their legally authorized representative are able to provide informed consent in English or Spanish. Exclusion Criteria: anticipation by the clinical provider of imminent patient death, or medical contraindication to tooth brushing.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Frequency of Once a Day<br>Tooth Brushing Protocol to be provided at 8:00 am (+/- 1.5 hours) | Procedure: Tooth Brushing Protocol<br>* A 2-minute tooth brushing protocol, followed by a mouthwash rinse and application of moisturizer for a total of approximately 15 minutes.<br>|
| Experimental: Frequency of Twice a Day<br>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) | Procedure: Tooth Brushing Protocol<br>* A 2-minute tooth brushing protocol, followed by a mouthwash rinse and application of moisturizer for a total of approximately 15 minutes.<br>|
| Experimental: Frequency of Three Times a Day<br>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) | Procedure: Tooth Brushing Protocol<br>* A 2-minute tooth brushing protocol, followed by a mouthwash rinse and application of moisturizer for a total of approximately 15 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral care