Impact of Teeth Brushing in Ventilated COVID-19 Patients.

• Sponsor: University Hospital in Krakow (Other)
• Overall Status: Completed
• CT.gov ID: NCT05575050
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Actual Duration (Months): 5
• Patients Per Site Per Month: 11.2

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Microbial Colonization; COVID-19 Respiratory Infection; Dysbiosis; VAP - Ventilator Associated Pneumonia; HAI	Procedure: Oral Procedure	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients were divided into 2 groups depending on the oral care procedure: Standard oral procedure (cleaning and moisturizing of oral cavity, suction of excess fluid) 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.Patients were divided into 2 groups depending on the oral care procedure:Standard oral procedure (cleaning and moisturizing of oral cavity, suction of excess fluid) 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.
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Impact of Teeth Brushing on Bacterial Microbiota and Healthcare-associated Infections in Ventilated COVID-19 Patients
• Actual Study Start Date: Sep 1, 2021
• Actual Primary Completion Date: Jan 31, 2022
• Actual Study Completion Date: Jan 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard oral procedure Standard mouth cleaning protocol (without brushing) included: Preparation of sterile catheter (12F lub 14F), suction of excess fluid from the oral cavity. Using Sage Suction Swab (Toothette®), soaking in Perox-A-Mint Solution and cleaning with circular movements of each mucosal site for 10 seconds: Right cheek mucosa and right upper quadrant Left cheek mucosa and left upper quadrant Left lower buccal quadrant Right lower buccal quadrant Moisturizing with Mouth Moisturizer /firma/ of oral cavity mucosa, tongue and lips. Repeated suction of excess fluid from the oral cavity.	Procedure: Oral Procedure; Interventions included 2 variants of oral hygienic procedures. One was extended of teeth brushing.
Active Comparator: Extended oral procedure Extended mouth cleaning protocol (with brushing) included: Preparation of sterile catheter (12F lub 14F), suction of excess fluid from the oral cavity. Teeth brushing (each teeth quadrant for 30) using Sage Untreated Suction Toothbrush (SUST) connected to suction unit, moistured with sterile water. Using Sage Untreated Suction Toothbrush (SUST) moisturised with sterile water and cleaning with circular movements of each mucosal site for 10 seconds: Right cheek mucosa and right upper quadrant Left cheek mucosa and left upper quadrant Left lower buccal quadrant Right lower buccal quadrant Moisturizing with Mouth Moisturizer of oral cavity mucosa, tongue and lips. Repeated suction of excess fluid from the oral cavity.	Procedure: Oral Procedure; Interventions included 2 variants of oral hygienic procedures. One was extended of teeth brushing.

Outcome Measures

Primary Outcome Measures

1. Healthcare-associated infection [one month]

   Healthcare-associated infection (HAI) incidence was measured.

Secondary Outcome Measures

1. Oral cavity assessment [one month]

   Using The Beck Oral Assessment Scale (BOAS)

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univeristy Hospital Kraków	Cracovia		Poland

Sponsors and Collaborators

• University Hospital in Krakow

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mateusz Fiema, MD, University Hospital in Krakow
• ClinicalTrials.gov Identifier: NCT05575050
• Other Study ID Numbers: 1072.6120.333.2020
• First Posted: Oct 12, 2022
• Last Update Posted: Oct 12, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mateusz Fiema, MD, University Hospital in Krakow: oral microbiota; healthcare-associated infection
• Additional relevant MeSH terms: Infections; Communicable Diseases; COVID-19; Respiratory Tract Infections; Pneumonia, Ventilator-Associated; Dysbiosis

Study Results

No Results Posted as of Oct 12, 2022