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Impact of Teeth Brushing in Ventilated COVID-19 Patients.

U

University Hospital in Krakow

Status

Completed

Conditions

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

Treatments

Procedure: Oral Procedure

Study type

Interventional

Funder types

Other

Identifiers

NCT05575050
1072.6120.333.2020

Details and patient eligibility

About

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)

Enrollment

56 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

56 participants in 2 patient groups

Standard oral procedure
Active Comparator group
Description:
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.
Treatment:
Procedure: Oral Procedure
Extended oral procedure
Active Comparator group
Description:
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.
Treatment:
Procedure: Oral Procedure

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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