Effect of oral chlorhexidine de-adoption and implementation of an oral care bundle on mortality for mechanically ventilated patients in the intensive care unit (CHORAL): a multi-center stepped wedge cluster-randomized controlled trial,Intensive Care Medicine

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Effect of oral chlorhexidine de-adoption and implementation of an oral care bundle on mortality for mechanically ventilated patients in the intensive care unit (CHORAL): a multi-center stepped wedge cluster-randomized controlled trial
Intensive Care Medicine ( IF 27.1 ) Pub Date : 2021-10-05 , DOI: 10.1007/s00134-021-06475-2
Craig M Dale _{1,

2,

3} , Louise Rose _{4,

5} , Sarah Carbone ₁ , Ruxandra Pinto ₆ , Orla M Smith _{1,

7,

8} , Lisa Burry _{5,

9,

10} , Eddy Fan _{5,

11} , Andre Carlos Kajdacsy-Balla Amaral _{3,

5,

6} , Victoria A McCredie _{5,

11,

12} , Damon C Scales _{3,

5,

6} , Brian H Cuthbertson _{3,

5,

6,

13}

Affiliation

Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, 155 College Street, Suite 130, Toronto, ON, M5T 1P8, Canada.
Trauma, Emergency and Critical Care, Sunnybrook Health Sciences Centre, Toronto, Canada.
Sunnybrook Research Institute, 2075 Bayview Avenue, Toronto, ON, M4N 3M5, Canada.
Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, 57 Waterloo Road, Room 1.1.3, London, SE1 8WA, UK.
Interdepartmental Division of Critical Care Medicine, Faculty of Medicine, University of Toronto, Toronto, Canada.
Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, 2075 Bayview Avenue, Toronto, ON, M4N 3M5, Canada.
Department of Critical Care, St. Michael's Hospital, 30 Bond Street, Toronto, ON, M5B 1W8, Canada.
Li Ka Shing Knowledge Institute, Toronto, Canada.
Department of Pharmacy, Mount Sinai Hospital, 600 University Avenue, Toronto, ON, M5G 1X5, Canada.
Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Canada.
Department of Medicine, University Health Network and Sinai Health System, 200 Elizabeth Street, Toronto, ON, M5G 2C4, Canada.
Krembil Research Institute, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.
Department of Anesthesiology and Pain Medicine, University of Toronto, Toronto, Canada.

Purpose

Oral chlorhexidine is used widely for mechanically ventilated patients to prevent pneumonia, but recent studies show an association with excess mortality. We examined whether de-adoption of chlorhexidine and parallel implementation of a standardized oral care bundle reduces intensive care unit (ICU) mortality in mechanically ventilated patients.

Methods

A stepped wedge cluster-randomized controlled trial with concurrent process evaluation in 6 ICUs in Toronto, Canada. Clusters were randomized to de-adopt chlorhexidine and implement a standardized oral care bundle at 2-month intervals. The primary outcome was ICU mortality. Secondary outcomes were time to infection-related ventilator-associated complications (IVACs), oral procedural pain and oral health dysfunction. An exploratory post hoc analysis examined time to extubation in survivors.

Results

A total of 3260 patients were enrolled; 1560 control, 1700 intervention. ICU mortality for the intervention and control periods were 399 (23.5%) and 330 (21.2%), respectively (adjusted odds ratio [aOR], 1.13; 95% confidence interval [CI] 0.82 to 1.54; P = 0.46). Time to IVACs (adjusted hazard ratio [aHR], 1.06; 95% CI 0.44 to 2.57; P = 0.90), time to extubation (aHR 1.03; 95% CI 0.85 to 1.23; P = 0.79) (survivors) and oral procedural pain (aOR, 0.62; 95% CI 0.34 to 1.10; P = 0.10) were similar between control and intervention periods. However, oral health dysfunction scores (− 0.96; 95% CI − 1.75 to − 0.17; P = 0.02) improved in the intervention period.

Conclusion

Among mechanically ventilated ICU patients, no benefit was observed for de-adoption of chlorhexidine and implementation of an oral care bundle on ICU mortality, IVACs, oral procedural pain, or time to extubation. The intervention may improve oral health.

中文翻译：

停用口服氯己定和实施口腔护理包对重症监护病房 (CHORAL) 机械通气患者死亡率的影响：一项多中心阶梯楔形集群随机对照试验

目的

口服氯己定被广泛用于机械通气患者以预防肺炎，但最近的研究表明与高死亡率有关。我们检查了不再采用氯己定和平行实施标准化口腔护理包是否会降低机械通气患者重症监护病房 (ICU) 的死亡率。

方法

在加拿大多伦多的 6 个 ICU 中进行的阶梯楔形集群随机对照试验，同时进行过程评估。集群被随机分配以停用洗必泰，并以 2 个月的间隔实施标准化的口腔护理包。主要结局是ICU死亡率。次要结果是感染相关呼吸机相关并发症 (IVAC)、口腔操作性疼痛和口腔健康功能障碍的时间。探索性事后分析检查了幸存者的拔管时间。

结果

共有 3260 名患者入组；1560控制，1700干预。干预期和控制期的 ICU 死亡率分别为 399（23.5%）和 330（21.2%）（调整优势比 [aOR]，1.13；95% 置信区间 [CI] 0.82 至 1.54；P = 0.46）。至 IVAC 的时间（调整后的风险比 [aHR]，1.06；95% CI 0.44 至 2.57；P = 0.90），拔管时间（aHR 1.03；95% CI 0.85 至 1.23；P = 0.79）（幸存者）和口腔操作性疼痛（aOR，0.62；95% CI 0.34 至 1.10；P = 0.10）在控制期和干预期之间相似。然而，口腔健康功能障碍评分（- 0.96；95% CI - 1.75 至 - 0.17；P = 0.02）在干预期间有所改善。