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OpenTrials
Completed

NCT Number: NCT05575050

Impact of Teeth Brushing in Ventilated COVID-19 Patients.

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)

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Key information

Conditions

Microbial Colonization COVID-19 Respiratory Infection Communicable Diseases Cross Infection Disease Attributes Dysbiosis HAI Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections VAP - Ventilator Associated Pneumonia

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univeristy Hospital Kraków

Krakow, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral Procedure

Procedure

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

Primary outcomes

  1. Healthcare-associated infection

    Time frame: one month

    Healthcare-associated infection (HAI) incidence was measured.

Secondary outcomes

  1. Oral cavity assessment

    Time frame: one month

    Using The Beck Oral Assessment Scale (BOAS)

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital in Krakow

Other

Registry information

Official study title

Impact of Teeth Brushing on Bacterial Microbiota and Healthcare-associated Infections in Ventilated COVID-19 Patients

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 12, 2022
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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