Clinical trial NCT02289131: Frequency of Oral Care Intervention Study
Official title: Oral Care Intervention In Mechanically Ventilated Adults: Renewal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Keywords: oral care
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: Tampa General Hospital
First posted: 2014-11-13
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dental Plaque as measured by University of Mississippi Oral Hygiene Index
timeFrame: Participants will be followed for the duration of the study, an expected average of 10 days.
measure: Gingival Inflammation as measured by Gingival Crevicular Fluid Samples
timeFrame: Participants will be followed for the duration of the study, an expected average of 10 days.
Secondary outcomes:
measure: Systemic Inflammatory Response Syndrome as measured by SIRS Criteria
timeFrame: Participants will be followed for the duration of the study, an expected average of 10 days.
measure: Hospital Acquired Infection as measured by positive epidemiologic surveillance report for VAE (including VAP), bacteremia, sepsis
timeFrame: Participants will be followed for the duration of the study, an expected average of 10 days.
measure: Length of Hospital Stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 10 days.
measure: Length of Intubation
timeFrame: Participants will be followed for the duration of the study, an expected average of 10 days.
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
Study officials:
affiliation: University of Miami
name: Cindy L Munro, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Florida
name: Kevin E Kip, PhD
role: PRINCIPAL_INVESTIGATOR
References: