Frequency of Oral Care Intervention Study — FOCIS  

Respiratory Failure Clinical Trial

Official title: Oral Care Intervention In Mechanically Ventilated Adults: Renewal

Status Completed

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

• NCT number: NCT02289131
• Study type: Interventional
• Source: University of South Florida
• Status: Completed
• Phase: N/A
• Start date: December 31, 2014
• Completion date: March 20, 2018