Impact of Teeth Brushing in Ventilated COVID-19 Patients.

Microbial Colonization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05575050
• Other study ID #: 1072.6120.333.2020
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: October 2022
• Source: University Hospital in Krakow
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Dysbiosis
• HAI
• Infections
• Microbial Colonization
• Pneumonia, Ventilator-Associated
• Respiratory Tract Infections
• VAP - Ventilator Associated Pneumonia

Intervention

Procedure:
• Oral Procedure
Interventions included 2 variants of oral hygienic procedures. One was extended of teeth brushing.

Locations

Country	Name	City	State
Poland	Univeristy Hospital Kraków	Cracovia

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital in Krakow

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healthcare-associated infection	Healthcare-associated infection (HAI) incidence was measured.	one month
Secondary	Oral cavity assessment	Using The Beck Oral Assessment Scale (BOAS)	one month
Secondary	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