A Systematic Oral Care Program in Post-Mechanically Ventilated, Post-Intensive Care Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in prevalence of Methicillin-sensitive Staphylococcus aureus (MSSA) in post mechanically ventilated patients as assessed by Oral cultures (Swabs)
研究概览
简要总结
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:
- Results in improved oral health compared to standard care,
- Reduces the rate of Staphylococcus aureus / methicillin resistant Staphylococcus aureus, and
- Reduces the risk of healthcare-associated infections.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
4-day systematic oral hygiene
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.
干预措施: 4-day systematic oral hygiene (Procedure)
Standard of Care oral care
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.
干预措施: Standard of Care oral care (Other)
结局指标
主要结局
Change in prevalence of Methicillin-sensitive Staphylococcus aureus (MSSA) in post mechanically ventilated patients as assessed by Oral cultures (Swabs)
时间窗: Day 1 and 4 days post-extubation
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)
Change in prevalence of Methicillin-resistant Staphylococcus aureus (MRSA) in post mechanically ventilated patients as assessed by Oral cultures (Swabs)
时间窗: Day 1 and 4 days post-extubation
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,
次要结局
- 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)
研究者
Esther Chipps
Director HS Nursing Quality & Research
Ohio State University