Impact of Teeth Brushing in Ventilated COVID-19 Patients.

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

The aims of this study were:

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)

Study Overview

• Status: Completed
• Conditions: Microbial Colonization; Dysbiosis; COVID-19 Respiratory Infection; HAI; VAP - Ventilator Associated Pneumonia
• Intervention / Treatment: Procedure: Oral Procedure

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Cracovia, Poland
    • Univeristy Hospital Kraków

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard oral procedure; 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 quadrantLeft cheek mucosa and left upper quadrantLeft lower buccal quadrantRight 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; Interventions included 2 variants of oral hygienic procedures. One was extended of teeth brushing.
Active Comparator: Extended oral procedure; 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 quadrantLeft cheek mucosa and left upper quadrantLeft lower buccal quadrantRight 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; Interventions included 2 variants of oral hygienic procedures. One was extended of teeth brushing.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital in Krakow

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: October 7, 2022
• First Submitted That Met QC Criteria: October 7, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 7, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: oral microbiota; healthcare-associated infection
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; COVID-19; Infections; Communicable Diseases; Respiratory Tract Infections; Pneumonia, Ventilator-Associated; Dysbiosis
• Other Study ID Numbers: 1072.6120.333.2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No