Frequency of Oral Care Intervention Study (FOCIS)

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure
• Intervention / Treatment: Procedure: Tooth Brushing Protocol

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.

• Study Type: Interventional
• Enrollment (Actual): 232
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University of South Florida
• Collaborators: National Institute of Nursing Research (NINR); Tampa General Hospital
• Investigators: Principal Investigator: Kevin E Kip, PhD, University of South Florida; Principal Investigator: Cindy L Munro, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2014
• Primary Completion (Actual): March 20, 2018
• Study Completion (Actual): March 20, 2018

Study Registration Dates

• First Submitted: November 4, 2014
• First Submitted That Met QC Criteria: November 12, 2014
• First Posted (Estimate): November 13, 2014

Study Record Updates

• Last Update Posted (Actual): November 6, 2018
• Last Update Submitted That Met QC Criteria: November 5, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: oral care
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: PRO 00016479; 2R01NR007652-10A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO