Impact of Teeth Brushing in Ventilated COVID-19 Patients.

Not Applicable

Completed

• Conditions: Microbial Colonization; COVID-19 Respiratory Infection; HAI; Dysbiosis; VAP - Ventilator Associated Pneumonia
• Interventions: Procedure: Oral Procedure

• Registration Number: NCT05575050
• Lead Sponsor: University Hospital in Krakow

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Status Verified: 2022-10
• Study First Submitted: 2022-10-07
• Study First Submitted QC: 2022-10-07
• Last Update Submitted: 2022-10-07
• Study First Posted: 2022-10-12
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard oral procedure	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.
Extended oral procedure	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.

Primary Outcome Measures

Name	Time	Method
Healthcare-associated infection	one month	Healthcare-associated infection (HAI) incidence was measured.

Secondary Outcome Measures

Name	Time	Method
Oral cavity assessment	one month	Using The Beck Oral Assessment Scale (BOAS)
Frequency of identification of Enterococcus fecalis, Acinetobacter baumannii, Klebsiella pneumoniae.	one month	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.

Trial Locations

Locations (1)

Univeristy Hospital Kraków; 🇵🇱 Cracovia, Poland