A Systematic Oral Care Program in Post-Mechanically Ventilated, Post-Intensive Care Patients
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Hospital |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/24/2019 |
| Start Date: | June 2011 |
| End Date: | December 2013 |
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.
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.
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.
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.
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
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