Impact of Teeth Brushing in Ventilated COVID-19 Patients.

Study Overview
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Brief Summary
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The aims of this study were: Observation of dynamics in oral microbiota and its association with the incidence of HAIs and VAP in mechanically ventilated COVID-19 patients in an ICU setting Evaluation of the incidence of HAIs and VAP and their association with oral bacteriobiota in mechanically ventilated COVID-19 patients in an ICU setting Assessment of impact of different oral hygienic procedures on oral microbiota, the incidence of HAI and patients' safety in mechanically ventilated COVID-19 patients in an ICU setting approaches to oral care in an ICU setting Intervention of oral hygienic procedures implemented in study: Patients were divided into 2 groups depending on the oral care procedure: Standard oral procedure (cleaning and moisturizing of oral cavity, suction of excess fluid) Extended oral procedure (cleaning and moisturizing of oral cavity, teeth brushing, suction of excess fluid)

Official Title
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Impact of Teeth Brushing on Bacterial Microbiota and Healthcare-associated Infections in Ventilated COVID-19 Patients

Conditions
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Dysbiosis, VAP - Ventilator Associated Pneumonia, HAI, Microbial Colonization, COVID-19 Respiratory Infection

Intervention / Treatment
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* Procedure: Oral Procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: SARS-CoV-2 infection confirmed by real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay of nasal and pharyngeal swabs upon hospital admission Signed consent to participate in the study Patients admitted to ICU Intubation due to COVID-19 related pneumonia and acute respiratory distress syndrome (ARDS) within 24 hours preceding study procedures Exclusion Criteria: No consent to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients were divided into 2 groups depending on the oral care procedure: Standard oral procedure (cleaning and moisturizing of oral cavity, suction of excess fluid) Extended oral procedure (cleaning and moisturizing of oral cavity, teeth brushing, suction of excess fluid) The procedures were performed twice daily in each patient. The detailed information on these procedures is included in the Appendix 1. The allocation protocol was based on patients' location in the ward. Each room was assigned with one type procedure (standard- even number or extended - uneven number of room), that was permanent during the study period.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard oral procedure<br>Standard mouth cleaning protocol (without brushing) included: Preparation of sterile catheter (12F lub 14F), suction of excess fluid from the oral cavity. Using Sage Suction Swab (Toothette®), soaking in Perox-A-Mint Solution and cleaning with circular movements of each mucosal site for 10 seconds: Right cheek mucosa and right upper quadrant Left cheek mucosa and left upper quadrant Left lower buccal quadrant Right lower buccal quadrant Moisturizing with Mouth Moisturizer /firma/ of oral cavity mucosa, tongue and lips. Repeated suction of excess fluid from the oral cavity. | Procedure: Oral Procedure<br>* Interventions included 2 variants of oral hygienic procedures. One was extended of teeth brushing.<br>|
| Active Comparator: Extended oral procedure<br>Extended mouth cleaning protocol (with brushing) included: Preparation of sterile catheter (12F lub 14F), suction of excess fluid from the oral cavity. Teeth brushing (each teeth quadrant for 30) using Sage Untreated Suction Toothbrush (SUST) connected to suction unit, moistured with sterile water. Using Sage Untreated Suction Toothbrush (SUST) moisturised with sterile water and cleaning with circular movements of each mucosal site for 10 seconds: Right cheek mucosa and right upper quadrant Left cheek mucosa and left upper quadrant Left lower buccal quadrant Right lower buccal quadrant Moisturizing with Mouth Moisturizer of oral cavity mucosa, tongue and lips. Repeated suction of excess fluid from the oral cavity. | Procedure: Oral Procedure<br>* Interventions included 2 variants of oral hygienic procedures. One was extended of teeth brushing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare-associated infection | Healthcare-associated infection (HAI) incidence was measured. | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral cavity assessment | Using The Beck Oral Assessment Scale (BOAS) | one month | 
| Frequency of identification of Enterococcus fecalis, Acinetobacter baumannii, Klebsiella pneumoniae. | Frequency of identification of Enterococcus fecalis, Acinetobacter baumannii, Klebsiella pneumoniae in different samples from oral cavity taken from ventilated COVID-19 patients on Intensive Care Unit. | one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral microbiota, healthcare-associated infection