Microbial ColonizationNCT05575050
Impact of Teeth Brushing in Ventilated COVID-19 Patients.
A study testing Oral Procedure in people with Microbial Colonization and COVID-19 Respiratory Infection, run by University Hospital in Krakow at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Microbial Colonization, COVID-19 Respiratory Infection, Dysbiosis
- What is being tested?
- Oral Procedure
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2021to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- No consent to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Teeth Brushing on Bacterial Microbiota and Healthcare-associated Infections in Ventilated COVID-19 Patients
The aims of this study were:
- 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
- Evaluation of the incidence of HAIs and VAP and their association with oral bacteriobiota in mechanically ventilated COVID-19 patients in an ICU setting
- 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
Read more
Intervention of oral hygienic procedures implemented in study:
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)
- Conditions
- Microbial Colonization, COVID-19 Respiratory Infection, Dysbiosis, VAP - Ventilator Associated Pneumonia, HAI
- Being tested
- Oral Procedure
- Keywords
- oral microbiota, healthcare-associated infection
- Medical subject headings
- Communicable Diseases, Dysbiosis, Pneumonia, Ventilator-Associated, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral ProcedureProcedure or surgery
Interventions included 2 variants of oral hygienic procedures. One was extended of teeth brushing.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Oral Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthcare-associated infection
Healthcare-associated infection (HAI) incidence was measured.
Measured: one month
Secondary outcomes (2)
Oral cavity assessment
Using The Beck Oral Assessment Scale (BOAS)
Measured: one month
Frequency of identification of Enterococcus fecalis, Acinetobacter baumannii, Klebsiella pneumoniae.
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.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start1 Sep 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital in Krakow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mateusz Fiema, University Hospital in Krakow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575050
- Sponsor's protocol ID
- 1072.6120.333.2020
- Status last verified
- Oct 2022
- First submitted
- 7 Oct 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Teeth Brushing on Bacterial Microbiota and Healthcare-associated Infections in Ventilated COVID-19 Patients
- ClinicalTrials.gov ID
- NCT05575050
- Acronym / sponsor ID
- 1072.6120.333.2020
- Conditions
- Microbial Colonization, COVID-19 Respiratory Infection, Dysbiosis, VAP - Ventilator Associated Pneumonia, HAI
- Keywords
- oral microbiota, healthcare-associated infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Hospital in KrakowUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aims of this study were:
- 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
- Evaluation of the incidence of HAIs and VAP and their association with oral bacteriobiota in mechanically ventilated COVID-19 patients in an ICU setting
- 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:
- 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)
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard oral procedure | Active comparator | Procedure: Oral ProcedureStandard 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 | Active comparator | Procedure: Oral ProcedureExtended 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- No consent to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral ProcedureInterventions included 2 variants of oral hygienic procedures. One was extended of teeth brushing. | Procedure or surgery | Extended oral procedure, Standard oral procedure |
Primary outcome
Healthcare-associated infection
Time frame: one month
Healthcare-associated infection (HAI) incidence was measured.
2 secondary outcomes
Oral cavity assessment
Time frame: one month
Frequency of identification of Enterococcus fecalis, Acinetobacter baumannii, Klebsiella pneumoniae.
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Procedure in people with Microbial Colonization and COVID-19 Respiratory Infection, run by University Hospital in Krakow at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthcare-associated infection (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.