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Impact of Teeth Brushing in Ventilated COVID-19 Patients.

Primary Purpose

Microbial Colonization, COVID-19 Respiratory Infection, Dysbiosis

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Oral Procedure
Sponsored by
University Hospital in Krakow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Microbial Colonization focused on measuring oral microbiota, healthcare-associated infection

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Univeristy Hospital Kraków

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Standard oral procedure

Extended oral procedure

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Healthcare-associated infection
Healthcare-associated infection (HAI) incidence was measured.

Secondary Outcome Measures

Oral cavity assessment
Using The Beck Oral Assessment Scale (BOAS)
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.

Full Information

First Posted
October 7, 2022
Last Updated
October 7, 2022
Sponsor
University Hospital in Krakow
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1. Study Identification

Unique Protocol Identification Number
NCT05575050
Brief Title
Impact of Teeth Brushing in Ventilated COVID-19 Patients.
Official Title
Impact of Teeth Brushing on Bacterial Microbiota and Healthcare-associated Infections in Ventilated COVID-19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital in Krakow

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microbial Colonization, COVID-19 Respiratory Infection, Dysbiosis, VAP - Ventilator Associated Pneumonia, HAI
Keywords
oral microbiota, healthcare-associated infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Non-Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard oral procedure
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Extended oral procedure
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Oral Procedure
Intervention Description
Interventions included 2 variants of oral hygienic procedures. One was extended of teeth brushing.
Primary Outcome Measure Information:
Title
Healthcare-associated infection
Description
Healthcare-associated infection (HAI) incidence was measured.
Time Frame
one month
Secondary Outcome Measure Information:
Title
Oral cavity assessment
Description
Using The Beck Oral Assessment Scale (BOAS)
Time Frame
one month
Title
Frequency of identification of Enterococcus fecalis, Acinetobacter baumannii, Klebsiella pneumoniae.
Description
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.
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Univeristy Hospital Kraków
City
Cracovia
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Impact of Teeth Brushing in Ventilated COVID-19 Patients.

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