Frequency of Oral Care Intervention Study
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/8/2018 |
| Start Date: | December 31, 2014 |
| End Date: | March 20, 2018 |
Oral Care Intervention In Mechanically Ventilated Adults: Renewal
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.
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.
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.
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.
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Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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