Respiratory Failure
Conditions
Keywords
oral care
Brief summary
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
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.
Interventions
PROCEDURETooth Brushing Protocol
A 2-minute tooth brushing protocol, followed by a mouthwash rinse and application of moisturizer for a total of approximately 15 minutes.
Sponsors
National Institute of Nursing Research (NINR)
Tampa General Hospital
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dental Plaque as measured by University of Mississippi Oral Hygiene Index | Participants will be followed for the duration of the study, an expected average of 10 days. | University of Mississippi Oral Hygiene Index |
| Gingival Inflammation as measured by Gingival Crevicular Fluid Samples | Participants will be followed for the duration of the study, an expected average of 10 days. | Gingival Crevicular Fluid Samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systemic Inflammatory Response Syndrome as measured by SIRS Criteria | Participants will be followed for the duration of the study, an expected average of 10 days. | SIRS Criteria |
| Hospital Acquired Infection as measured by positive epidemiologic surveillance report for VAE (including VAP), bacteremia, sepsis | Participants will be followed for the duration of the study, an expected average of 10 days. | positive epidemiologic surveillance report for Ventilator Associated Event (including VAP), bacteremia, sepsis |
| Length of Hospital Stay | Participants will be followed for the duration of hospital stay, an expected average of 10 days. | Number of days from hospital admission date to hospital discharge date |
| Length of Intubation | Participants will be followed for the duration of the study, an expected average of 10 days. | Number of days from intubation date to extubation date |
Countries
United States
Outcome results
None listed