A Systematic Oral Care Program in Post-Mechanically Ventilated, Post-Intensive Care Patients

NCT03886623 | Completed

• 1 other identifier: 2011H0015
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if a 4 day oral care program in patients who have been on a breathing machine results in better oral health, reduces the amount of certain bacteria in the mouth and reduces infection while in the hospital. The plan is to test the specific hypotheses that a standardized oral care protocol:

1. 1.Results in improved oral health compared to standard care,
2. 2.Reduces the rate of Staphylococcus aureus / methicillin resistant Staphylococcus aureus, and
3. 3.Reduces the risk of healthcare-associated infections.

Conditions

Methicillin-resistant Staphylococcus Aureus; Methicillin-Sensitive Staphylococcus Aureus Infection

Outcome Measures

Primary Outcomes (2)

• Change in prevalence of Methicillin-sensitive Staphylococcus aureus (MSSA) in post mechanically ventilated patients as assessed by Oral cultures (Swabs)

  The overall purpose of this project is to develop an evidence-based oral care protocol for acutely ill hospitalized patients and determine the impact of this protocol on health outcomes in recently extubated patients. The aim is to assess the impact of an oral care protocol on the following rate of oral colonization with Methicillin-sensitive Staphylococcus aureus (MSSA)

  Day 1 and 4 days post-extubation

• Change in prevalence of Methicillin-resistant Staphylococcus aureus (MRSA) in post mechanically ventilated patients as assessed by Oral cultures (Swabs)

  The overall purpose of this project is to develop an evidence-based oral care protocol for acutely ill hospitalized patients and determine the impact of this protocol on health outcomes in recently extubated patients. The aim is to assess the impact of an oral care protocol on the following rate of MRSA,

  Day 1 and 4 days post-extubation

Secondary Outcomes (3)

• Determine infection rate of healthcare acquired infections (MSSA and MRSA) in post mechanically ventilated patients receiving oral care using nasal cultures (Swabs)

  4 days

• Identify change in patient satisfaction in post mechanically ventilated patients who receive oral care using a Patient satisfaction survey/interview.

  4 days post extubation

• Identify change in patient quality of life in post mechanically ventilated patients who receive oral care using the Edmonton Symptom Assessment System quality of life assessment tool.

  4 days post extubation

Study Arms (2)

4-day systematic oral hygiene

EXPERIMENTAL

The intervention proposed would include a 4-5 day systematic oral hygiene program. Using a pea-sized amount of Colgate Total Clean Mint Toothpaste with a Battery-operated Oral-B Pro-Health Type 3744 toothbrush, all surfaces, tongue-side, check-side, and biting surfaces of the participants teeth will be brushed. The tongue will be brushed with a GUM Dual Action Tongue Cleaner and flossing will be done with GUM Flossmate handle and Oral B Guide Floss in between the contacts of each tooth. The mouth will then be rinsed with Crest Pro-Health mouthwash rinse for 30 seconds twice daily. A Medline Remedy Phytoplex lip balm will then be applied.

Procedure: 4-day systematic oral hygiene

Standard of Care oral care

OTHER

Standard of Care oral care. Currently, the intensive care units utilize a commercially available pre-package oral hygiene kit. This includes mouthwash swabbing every 2 hours with Careline Alcohol-Free mouthwash or Sage Alcohol Free mouthwash, teeth brushing (with Sage Toothette Oral Care, Sodium Bicarbonate Toothpaste and Sage Suction Toothbrush) every 12 hours, deep oral suctioning every 8 hours and prior to oral Endotracheal tube (ET) retaping, and Paroex Oral Rinse chlorohexidine gluconate (15ml) swabbed onto oral surfaces every 12 hours (SICU patients only). Mouth care is documented every two hours.

Other: Standard of Care oral care

Interventions

4-day systematic oral hygiene PROCEDURE

he intervention proposed would include a 4-5 day systematic oral hygiene program. Using a pea-sized amount of Colgate Total Clean Mint Toothpaste with a Battery-operated Oral-B Pro-Health Type 3744 toothbrush, all surfaces, tongue-side, check-side, and biting surfaces of the participants teeth will be brushed. The tongue will be brushed with a GUM Dual Action Tongue Cleaner and flossing will be done with GUM Flossmate handle and Oral B Guide Floss in between the contacts of each tooth. The mouth will then be rinsed with Crest Pro-Health mouthwash rinse for 30 seconds twice daily. A Medline Remedy Phytoplex lip balm will then be applied.

4-day systematic oral hygiene

Standard of Care oral care OTHER

Standard of Care oral care. Currently, the intensive care units utilize a commercially available pre-package oral hygiene kit. This includes mouthwash swabbing every 2 hours with Careline Alcohol-Free mouthwash or Sage Alcohol Free mouthwash, teeth brushing (with Sage Toothette Oral Care, Sodium Bicarbonate Toothpaste and Sage Suction Toothbrush) every 12 hours, deep oral suctioning every 8 hours and prior to oral Endotracheal tube (ET) retaping, and Paroex Oral Rinse chlorohexidine gluconate (15ml) swabbed onto oral surfaces every 12 hours (SICU patients only). Mouth care is documented every two hours.

Standard of Care oral care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Has required mechanical ventilation for at least 48 hours
• Meets ventilator liberation criteria (PEEP ≤ 8 and FiO2 ≤ 50%)
• Minimum of 3 teeth
• Either the subject or their Legally Authorized Representative is capable of reading, understanding and providing written informed consent.

You may not qualify if:

• Non-English speaking
• Allergy to products/components of the oral care protocol
• Oral or maxillofacial surgery, or oral/facial trauma in last three months
• INR \> 3.5 or platelet count \< 20,000
• Planned hospital discharge within 48 hours
• Current diagnosis of mucositis, or undergoing chemotherapy or radiation therapy
• Presence of Tracheostomy
• Family or physician not in favor of continued medical treatment.
• Unable to give informed consent, and/or lack of availability of an authorized representative who can provide consent

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43015, United States

Location

Study Officials

• Esther Chipps, RN,PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director HS Nursing Quality & Research

Study Record Dates

• First Submitted: October 9, 2012
• First Posted: March 22, 2019
• Study Start: June 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 22, 2019

Record last verified: 2019-03

Locations

US (1)