Frequency of Oral Care Intervention Study

Respiratory Failure Clinical Trial

— FOCIS  

Official title:

Oral Care Intervention In Mechanically Ventilated Adults: Renewal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02289131
• Other study ID #: PRO 00016479
• Secondary ID: 2R01NR007652-10A
• Status: Completed
• Phase: N/A
• Start date: December 31, 2014
• Est. completion date: March 20, 2018

Study information

• Verified date: October 2018
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: March 20, 2018
• Est. primary completion date: March 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
United States	Tampa General Hospital	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of South Florida	National Institute of Nursing Research (NINR), Tampa General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.