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Completed

NCT Number: NCT02289131

Frequency of Oral Care Intervention Study

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.

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Key information

Conditions

Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tampa General Hospital

Tampa, Florida, 33606, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tooth Brushing Protocol

Procedure

A 2-minute tooth brushing protocol, followed by a mouthwash rinse and application of moisturizer for a total of approximately 15 minutes.

Primary outcomes

  1. Dental Plaque as measured by University of Mississippi Oral Hygiene Index

    Time frame: Participants will be followed for the duration of the study, an expected average of 10 days.

    University of Mississippi Oral Hygiene Index

  2. Gingival Inflammation as measured by Gingival Crevicular Fluid Samples

    Time frame: Participants will be followed for the duration of the study, an expected average of 10 days.

    Gingival Crevicular Fluid Samples

Secondary outcomes

  1. Systemic Inflammatory Response Syndrome as measured by SIRS Criteria

    Time frame: Participants will be followed for the duration of the study, an expected average of 10 days.

    SIRS Criteria

  2. Hospital Acquired Infection as measured by positive epidemiologic surveillance report for VAE (including VAP), bacteremia, sepsis

    Time frame: Participants will be followed for the duration of the study, an expected average of 10 days.

    positive epidemiologic surveillance report for Ventilator Associated Event (including VAP), bacteremia, sepsis

  3. Length of Hospital Stay

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days.

    Number of days from hospital admission date to hospital discharge date

  4. Length of Intubation

    Time frame: Participants will be followed for the duration of the study, an expected average of 10 days.

    Number of days from intubation date to extubation date

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

  • National Institute of Nursing Research (NINR)
  • Tampa General Hospital

Registry information

Official study title

Oral Care Intervention In Mechanically Ventilated Adults: Renewal

Acronym: FOCIS

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Nov 13, 2014
Registry last updated
Nov 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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