Impact of Teeth Brushing in Ventilated COVID-19 Patients.
NCT ID: NCT05575050
Last Updated: 2022-10-12
Study Results
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Basic Information
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COMPLETED
NA
56 participants
INTERVENTIONAL
2021-09-01
2022-01-31
Brief Summary
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1. 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
2. Evaluation of the incidence of HAIs and VAP and their association with oral bacteriobiota in mechanically ventilated COVID-19 patients in an ICU setting
3. 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:
1. Standard oral procedure (cleaning and moisturizing of oral cavity, suction of excess fluid)
2. Extended oral procedure (cleaning and moisturizing of oral cavity, teeth brushing, suction of excess fluid)
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
1. Standard oral procedure (cleaning and moisturizing of oral cavity, suction of excess fluid)
2. 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.
PREVENTION
SINGLE
Study Groups
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Standard oral procedure
Standard mouth cleaning protocol (without brushing) included:
1. Preparation of sterile catheter (12F lub 14F), suction of excess fluid from the oral cavity.
2. Using Sage Suction Swab (Toothette®), soaking in Perox-A-Mint Solution and cleaning with circular movements of each mucosal site for 10 seconds:
1. Right cheek mucosa and right upper quadrant
2. Left cheek mucosa and left upper quadrant
3. Left lower buccal quadrant
4. Right lower buccal quadrant
3. Moisturizing with Mouth Moisturizer /firma/ of oral cavity mucosa, tongue and lips.
4. Repeated suction of excess fluid from the oral cavity.
Oral Procedure
Interventions included 2 variants of oral hygienic procedures. One was extended of teeth brushing.
Extended oral procedure
Extended mouth cleaning protocol (with brushing) included:
1. Preparation of sterile catheter (12F lub 14F), suction of excess fluid from the oral cavity.
2. Teeth brushing (each teeth quadrant for 30) using Sage Untreated Suction Toothbrush (SUST) connected to suction unit, moistured with sterile water.
3. Using Sage Untreated Suction Toothbrush (SUST) moisturised with sterile water and cleaning with circular movements of each mucosal site for 10 seconds:
1. Right cheek mucosa and right upper quadrant
2. Left cheek mucosa and left upper quadrant
3. Left lower buccal quadrant
4. Right lower buccal quadrant
4. Moisturizing with Mouth Moisturizer of oral cavity mucosa, tongue and lips.
5. Repeated suction of excess fluid from the oral cavity.
Oral Procedure
Interventions included 2 variants of oral hygienic procedures. One was extended of teeth brushing.
Interventions
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Oral Procedure
Interventions included 2 variants of oral hygienic procedures. One was extended of teeth brushing.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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University Hospital in Krakow
OTHER
Responsible Party
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Mateusz Fiema
MD
Locations
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Univeristy Hospital Kraków
Krakow, , Poland
Countries
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Other Identifiers
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1072.6120.333.2020
Identifier Type: -
Identifier Source: org_study_id
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