NCT02289131

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

December 31, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2018

Completed
Last Updated

November 6, 2018

Status Verified

October 1, 2018

Enrollment Period

3.2 years

First QC Date

November 4, 2014

Last Update Submit

November 5, 2018

Conditions

Respiratory Failure

Keywords

oral care

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Systemic Inflammatory Response Syndrome as measured by 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

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

  • Length of Hospital Stay

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

  • Length of Intubation

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

Study Arms (3)

Frequency of Once a Day

EXPERIMENTAL

Tooth Brushing Protocol to be provided at 8:00 am (+/- 1.5 hours)

Procedure: Tooth Brushing Protocol

Frequency of Twice a Day

EXPERIMENTAL

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

Frequency of Three Times a Day

EXPERIMENTAL

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

Interventions

Tooth Brushing ProtocolPROCEDURE

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

Frequency of Once a DayFrequency of Three Times a DayFrequency of Twice a Day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • anticipation by the clinical provider of imminent patient death, or
  • medical contraindication to tooth brushing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Cindy L Munro, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

  • Kevin E Kip, PhD

    University of South Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2014

First Posted

November 13, 2014

Study Start

December 31, 2014

Primary Completion

March 20, 2018

Study Completion

March 20, 2018

Last Updated

November 6, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)