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

Methicillin-resistant Staphylococcus Aureus Clinical Trial

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

Status Completed

Clinical Trial 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. Results in improved oral health compared to standard care,

2. Reduces the rate of Staphylococcus aureus / methicillin resistant Staphylococcus aureus, and

3. Reduces the risk of healthcare-associated infections.

Clinical Trial Description

Upon meeting inclusion criteria and consenting to participate, the subject will be enrolled in the study. Upon extubation, the subject will be randomly assigned using a computer generated table of random numbers to either the intervention or control group. Daily safety checks including reviewing INR and platelet counts (if performed) will be performed to ensure patient has maintained eligibility for the study.

Study Intervention:

Control Arm:

Current practice in the intensive care units includes the provision of oral care as part of the Ventilator Bundle guideline focused on the reduction of VAP. Currently, the intensive care units utilize a commercially available pre-package oral hygiene kit. This includes mouth care (alcohol free mouthrinse and hydrogen peroxide) with swabs every 2 hours, tooth brushing (suction toothbrush with anti- plaque paste) every 12 hours, deep oral suctioning every 8 hours and prior to ET tube retaping, and chlorohexidine gluconate (15ml) swabbed onto oral surfaces every 12 hours (SICU patients only). Mouth care is documented every two hours.

On the progressive care units and general medical-surgical units, routine oral care is provided as part of the general hygiene care of the units, and based on the clinical determination of the nurse. The selection of oral care techniques currently used on the progressive care units is determined by the level of independence of the patient and oral hygiene needs of the patient. Two techniques are currently being implemented: 1) toothbrushing using a basic toothbrush and basic oral care products provided by the hospital every 12- 24 hours. 2) The prepackaged suctioning kit which includes suction toothbrush with toothpaste and suction oral swabs with alcohol-free mouth rinse, and hydrogen peroxide every 4 hours or based on clinical judgement. Lip moisturizer is applied inside the mouth and on the lips.

Intervention Arm The intervention proposed would include a 4-5 day systematic oral hygiene program provided to patients who are post-extubation. The proposed intervention would begin in the intensive care unit within 24 hours post-extubation and when the patient is determined to be medically stable. The protocol would be initiated with an intensive oral hygiene intervention (see Appendix A) with selected oral hygiene products in the post-extubation period. Following the oral hygiene intervention of the oral cavity, the intervention would continue even if the patient transitions from the intensive care setting to either the progressive care unit or general medical-surgical unit. The intervention will be provided by the Clinical Nurse Specialist (key personnel) from the Division of Critical Care Nursing and Medical-Surgical Nursing. The oral hygiene program will be provided a total of 9 times. ;

Related Conditions & MeSH terms

• Methicillin-resistant Staphylococcus Aureus
• Methicillin-Sensitive Staphylococcus Aureus Infection
• Staphylococcal Infections

• NCT number: NCT03886623
• Study type: Interventional
• Source: Ohio State University
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Completion date: December 2013