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| Name | Class |
|---|---|
| University of Sao Paulo | OTHER |
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The oral hygiene method commonly used in intubated patients orotracheal is tooth brushing (mechanical removal) and washing the oral cavity and the orotracheal tube (TOT) with digluconate solution chlorhexidine (CLX). However, recent studies have demonstrated that the use of CLX in these conditions may expose the patient to a potential increased risk of mortality. Recent recommendations made by international bodies related to hospital biosafety no longer include the use of CLX in ICU oral hygiene routine. A question not yet answered in the literature is whether the absence of CLX in the critical patient's oral hygiene routine predisposes increased accumulation of dental plaque or microbial colonization related to the risk of systemic complications, such as pneumonia and sepsis. The cost-effectiveness of this protocol change also needs to be evaluated, as the withdrawal of CLX may result in changes in the risk profile morbidity and mortality during hospitalization. The present study aims to investigate whether brushing the oral cavity with mineral water changes the pattern of biofilm accumulation and clinical appearance of the oral mucosa in relation to brushing done with CLX. Microbiological analysis of the oropharyngeal biofilm and cost-effectiveness impact assessment will also be carried out.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine | Active Comparator | patients with oral hygiene performed with tooth brushing and washing with 0.12% chlorhexidine |
|
| Water | Sham Comparator | patients with oral hygiene performed with tooth brushing and washing with filtered water. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral care | Other | The intervention group procedure will be carried out in the same way and frequency of the control group, however, replacing the chlorhexidine solution 0.12% for mineral water. Oral hygiene will be carried out by the nursing team, which will be blind to the indices to be evaluated. The team will be previously trained to carry out hygiene procedures by the team of ICU dental surgeons. |
| Measure | Description | Time Frame |
|---|---|---|
| Analyze oral cavity brushing | Analyze oral cavity brushing done with mineral water in the ICU in regarding the accumulation of biofilm and the appearance of the oral mucosa and compare these variables with brushing done with CLX. | T0 (baseline) - first day of intubation; • T1 - after 3 days of intubation or immediately after extubation (with a minimum of 1 day of intubation); • T2 - after 7 days of intubation (if you still remain intubated). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fernanda P Eduardo, PhD | Contact | 5511999037553 | fpeduard@einstein.br |
| Name | Affiliation | Role |
|---|---|---|
| Fernanda de P Eduardo | Hospital Israelita Albert Einstein | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital israelita Albert Einstein | Recruiting | São Paulo | 05652-900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35589091 | Background | Klompas M, Branson R, Cawcutt K, Crist M, Eichenwald EC, Greene LR, Lee G, Maragakis LL, Powell K, Priebe GP, Speck K, Yokoe DS, Berenholtz SM. Strategies to prevent ventilator-associated pneumonia, ventilator-associated events, and nonventilator hospital-acquired pneumonia in acute-care hospitals: 2022 Update. Infect Control Hosp Epidemiol. 2022 Jun;43(6):687-713. doi: 10.1017/ice.2022.88. Epub 2022 May 20. | |
| 25376073 |
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| ID | Term |
|---|---|
| D000091982 | Dental Care Team |
| ID | Term |
|---|---|
| D010348 | Patient Care Team |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| Background |
| Klompas M, Branson R, Eichenwald EC, Greene LR, Howell MD, Lee G, Magill SS, Maragakis LL, Priebe GP, Speck K, Yokoe DS, Berenholtz SM. Strategies to prevent ventilator-associated pneumonia in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014 Sep;35 Suppl 2:S133-54. doi: 10.1017/s0899823x00193894. No abstract available. |
| 23702324 | Background | Prendergast V, Kleiman C, King M. The Bedside Oral Exam and the Barrow Oral Care Protocol: translating evidence-based oral care into practice. Intensive Crit Care Nurs. 2013 Oct;29(5):282-90. doi: 10.1016/j.iccn.2013.04.001. Epub 2013 May 20. |
| 31775844 | Background | Bellissimo-Rodrigues WT, Menegueti MG, de Macedo LD, Basile-Filho A, Martinez R, Bellissimo-Rodrigues F. Oral mucositis as a pathway for fatal outcome among critically ill patients exposed to chlorhexidine: post hoc analysis of a randomized clinical trial. Crit Care. 2019 Nov 27;23(1):382. doi: 10.1186/s13054-019-2664-6. No abstract available. |
| 33368159 | Background | Zhao T, Wu X, Zhang Q, Li C, Worthington HV, Hua F. Oral hygiene care for critically ill patients to prevent ventilator-associated pneumonia. Cochrane Database Syst Rev. 2020 Dec 24;12(12):CD008367. doi: 10.1002/14651858.CD008367.pub4. |