Clinical trial NCT05575050: 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
Overall status: COMPLETED
Phase: NA
Conditions: Microbial Colonization
COVID-19 Respiratory Infection
Dysbiosis
VAP - Ventilator Associated Pneumonia
HAI
Keywords: oral microbiota
healthcare-associated infection
Lead sponsor: University Hospital in Krakow
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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) 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.
Primary purpose: PREVENTION

Brief 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)


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

Primary outcomes:
measure: Healthcare-associated infection
timeFrame: one month
Secondary outcomes:
measure: Oral cavity assessment
timeFrame: one month
measure: Frequency of identification of Enterococcus fecalis, Acinetobacter baumannii, Klebsiella pneumoniae.
timeFrame: one month
Other outcomes:
Locations:
city: Cracovia
country: Poland
facility: Univeristy Hospital Kraków
Study officials:
References: