Impact of Teeth Brushing in Ventilated COVID-19 Patients.

NCT05575050 | Completed

• 1 other identifier: 1072.6120.333.2020
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this study were:

1. 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. 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. 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
4. 4.Standard oral procedure (cleaning and moisturizing of oral cavity, suction of excess fluid)
5. 5.Extended oral procedure (cleaning and moisturizing of oral cavity, teeth brushing, suction of excess fluid)

Conditions

Microbial Colonization; COVID-19 Respiratory Infection; Dysbiosis; VAP - Ventilator Associated Pneumonia; HAI

Keywords

oral microbiota; healthcare-associated infection

Outcome Measures

Primary Outcomes (1)

• Healthcare-associated infection

  Healthcare-associated infection (HAI) incidence was measured.

  one month

Secondary Outcomes (2)

• Oral cavity assessment

  one month

• Frequency of identification of Enterococcus fecalis, Acinetobacter baumannii, Klebsiella pneumoniae.

  one month

Study Arms (2)

Standard oral procedure

ACTIVE COMPARATOR

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.

Procedure: Oral Procedure

Extended oral procedure

ACTIVE COMPARATOR

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.

Procedure: Oral Procedure

Interventions

Oral Procedure PROCEDURE

Interventions included 2 variants of oral hygienic procedures. One was extended of teeth brushing.

Extended oral procedure; Standard oral procedure

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• No consent to participate in the study

Sponsors & Collaborators

• University Hospital in Krakow: lead

Study Sites (1)

Univeristy Hospital Kraków

Krakow, Poland

Location

MeSH Terms

Conditions

Communicable Diseases; Dysbiosis; Pneumonia, Ventilator-Associated; Cross Infection

Interventions

Methods

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Healthcare-Associated Pneumonia; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: 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.

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 12, 2022
• Study Start: September 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Locations

PL (1)