Clinical trial NCT03886623: A Systematic Oral Care Program in Post-Mechanically Ventilated, Post-Intensive Care Patients
Official title: A Systematic Oral Care Program in Post-Mechanically Ventilated, Post-Intensive Care Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Methicillin-resistant Staphylococcus Aureus
Methicillin-Sensitive Staphylococcus Aureus Infection
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2019-03-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in prevalence of Methicillin-sensitive Staphylococcus aureus (MSSA) in post mechanically ventilated patients as assessed by Oral cultures (Swabs)
timeFrame: Day 1 and 4 days post-extubation
measure: Change in prevalence of Methicillin-resistant Staphylococcus aureus (MRSA) in post mechanically ventilated patients as assessed by Oral cultures (Swabs)
timeFrame: Day 1 and 4 days post-extubation
Secondary outcomes:
measure: Determine infection rate of healthcare acquired infections (MSSA and MRSA) in post mechanically ventilated patients receiving oral care using nasal cultures (Swabs)
timeFrame: 4 days
measure: Identify change in patient satisfaction in post mechanically ventilated patients who receive oral care using a Patient satisfaction survey/interview.
timeFrame: 4 days post extubation
measure: 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.
timeFrame: 4 days post extubation
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Esther Chipps, RN,PhD
role: PRINCIPAL_INVESTIGATOR
References: