Oral Care Frequency in Mechanically Ventilated Patients

July 18, 2022 updated by: Aslıhan Tahtali Turgut, Aydin Adnan Menderes University

The Effect of Oral Care Frequency on Oral Mucosa Membrane Integrity in Patients With Mechanical Ventilation Support

Many problems may develop in patients due to mechanical ventilation in intensive care units. These include ventilator-associated pneumonia, decreased cerebral perfusion, venous air embolism, sinus and eye infections, neuromuscular dysfunctions and skin sores may be seen in intensive care patients undergoing mechanical ventilation. If adequate oral hygiene is not provided in patients on mechanical ventilation support, dry mouth, halitosis, disruption of tissue integrity in and around the mouth, intraoral infections and periodontal diseases may occur. Most importantly, ventilator-associated pneumonia (VIP) may develop in patients dependent on mechanical ventilation due to deficient oral care.

Chlorhexidine solution is widely used in oral care. However, there is a need for evidence about the frequency of oral care with which chlorhexidine solution on oral mucous membrane integrity in patients under mechanical ventilation support. Oral care frequency was not examined in these existing studies. Therefore, this study was planned to determine the effect of three different oral care frequencies on the integrity of the oral mucous membrane in patients connected to mechanical ventilators.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Oral hygiene is one of the applications where the individual needs the most hygienic care. Providing oral care and maintaining oral hygiene improves the comfort and quality of life by ensuring that the individual eats healthy and feels well.Inadequate oral care can negatively affect all these, as well as cause problems such as dry mouth, dental caries, periodontal diseases, bad breath and stomatitis.Therefore, in order to maintain oral health, individuals must perform oral care effectively.

Nurses need to have adequate oral intake to maintain the integrity of the oral mucosa, especially in patients who cannot be fed orally, with fluid restriction, administered nasogastric tube, mouth breathing, receiving oxygen therapy, undergoing oral and maxillofacial surgery, undergoing radiation therapy, chemotherapy, in the terminal period, in coma, and in patients dependent on mechanical ventilator. care must be provided.

Defense mechanisms in intensive care patients are affected by their disease and multiple interventions that circumvent natural host defenses. Treatments applied in intensive care units, lack of fluid intake of the patient, and some materials used for treatment and care cause changes in the oral mucous membrane. Inadequate protective mechanisms in patients can lead to both local and systemic complications such as caries, periodontal disease, oral mucosal infections, and ventilator-associated pneumonia.

Bacterial oropharyngeal colonization progressively changes to tracheal colonization leading to ventilator-associated pneumonia.

Especially in patients connected to mechanical ventilators, the entry of bacteria into the respiratory tract is facilitated and increased due to the endotracheal tube, causing the coughing reflex and mucociliar activity to be impaired and secretion to increase. In this case, gram-positive bacteria that make up the normal flora in the oral mucosa are replaced by gram-negative bacteria, causing changes in the oral flora and plaque formation on the teeth. Therefore, oral care becomes much more important.The solution and frequency to be used gain importance for oral care to be effective on the integrity of the oral mucous membrane.

In the literature, it is recommended to use chlorhexidine gluconate solution in oral care to prevent the development of ventilator-associated pneumonia in mechanically ventilated patients.However, there is no evidence on how often oral care should be performed.

When the literature is reviewed, further studies with conclusive evidence to show how often chlorhexidine gluconate is effective are needed. For this reason, this study was planned to determine the effect of three different oral care frequencies on the integrity of the oral mucous membrane in patients dependent on mechanical ventilators.

The research is planned to be carried out between 01.06.2021 and 01.06.2022 in the internal medicine intensive care unit of Aydın Adnan Menderes University Practice and Research Hospital.

The population of the research is the patients hospitalized in the Internal Medicine intensive care unit of Aydın Adnan Menderes University Practice and Research Hospital between 01.06.2021 and 01.06.2022, and the sample is; Patients who are older than 18 years of age, who are in the first 24 hours of mechanical ventilation, who are 18 years of age and older, and whose relatives have consented. The sample of the research; Patients with thrombocytopenia, leukopenia and oral aphthae, stomatitis, candiasis, gingivitis who have had an oral surgical procedure will not be accepted.

Before starting the practice in this study, the purpose of the research will be explained to all nurses working in the unit by the researchers and an information meeting about oral care will be held. After the operability of the guide in the intensive care unit is ensured, the data collection phase will begin. Randomization of patients will be done by the nurse in charge of the service.

The frequency of oral care of the patients will be in three groups. Oral care will be done twice a day for the patients in the first group, 3 times a day for the patients in the second group, and 4 times a day for the patients in the third group. Oral care of the patients will be applied according to the guide used in the training given to the nurses. In oral care, 0.12% chlorhexidine solution will be used.

The concentration of 0.12% of the chlorhexidine gluconate solution planned to be used in the research is the most frequently used form compared to the other concentrations of the solution. And no side effects were noted in the studies.

For this reason, 0.12% chlorhexidine solution was preferred. When the literature is examined, this density was preferred because it is the most frequently used solution in the oral care of patients under mechanical ventilation support.

The oral mucosa of the patients will be evaluated with the Oral Evaluation Scale by the researcher before the first oral care application every morning for four days. According to the score obtained from the scale, the researcher will evaluate the patients as normal oral mucosa, mild dysfunction, moderate dysfunction and severe dysfunction.

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Efeler
      • Aydın, Efeler, Turkey, 09100
        • Aydın Adnan Menderes University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • who are over 18 years old,
  • In the first 24 hours of mechanical ventilation,
  • It will consist of patients with consent from their relatives.

Exclusion Criteria:

  • Surgery for the mouth,
  • Patients with oral aphthae, stomatitis, candiasis, gingivitis will not be taken.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: first group
The patients in the first group will be given oral care with 0.12% chlorhexidine twice a day.
Other: chlorhexidine
The population of the research is the patients hospitalized in the Internal Medicine intensive care unit of Aydın Adnan Menderes University Practice and Research Hospital between 01.06.2021 and 01.06.2022, and the sample is; Patients who are older than 18 years of age, who are in the first 24 hours of mechanical ventilation, who are 18 years of age and older, and whose relatives have consented.Oral care of the patients will be done with 0.12% chlorhexidine solution, and the frequency of oral care will be in three groups. Oral care will be done twice a day for the patients in the first group, 3 times a day for the patients in the second group, and 4 times a day for the patients in the third group. Oral care of the patients will be applied according to the guide used in the training given to the nurses.
Experimental: second group
The patients in the second group will be given oral care with 0.12% chlorhexidine 3 times a day.
Other: chlorhexidine
The population of the research is the patients hospitalized in the Internal Medicine intensive care unit of Aydın Adnan Menderes University Practice and Research Hospital between 01.06.2021 and 01.06.2022, and the sample is; Patients who are older than 18 years of age, who are in the first 24 hours of mechanical ventilation, who are 18 years of age and older, and whose relatives have consented.Oral care of the patients will be done with 0.12% chlorhexidine solution, and the frequency of oral care will be in three groups. Oral care will be done twice a day for the patients in the first group, 3 times a day for the patients in the second group, and 4 times a day for the patients in the third group. Oral care of the patients will be applied according to the guide used in the training given to the nurses.
Experimental: third group
The patients in the third group will be given oral care with 0.12% chlorhexidine 4 times a day.
Other: chlorhexidine
The population of the research is the patients hospitalized in the Internal Medicine intensive care unit of Aydın Adnan Menderes University Practice and Research Hospital between 01.06.2021 and 01.06.2022, and the sample is; Patients who are older than 18 years of age, who are in the first 24 hours of mechanical ventilation, who are 18 years of age and older, and whose relatives have consented.Oral care of the patients will be done with 0.12% chlorhexidine solution, and the frequency of oral care will be in three groups. Oral care will be done twice a day for the patients in the first group, 3 times a day for the patients in the second group, and 4 times a day for the patients in the third group. Oral care of the patients will be applied according to the guide used in the training given to the nurses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral mucosal evaluation of patients.
Time Frame: Oral care is given to patient groups 2 times a day, 3 times a day, 4 times a day for 4 days. Evaluation will be done at the beginning of the study and every day for 4 days.
The oral mucosa of the patients will be evaluated with the Eilers Mouth Rating Scale.
Oral care is given to patient groups 2 times a day, 3 times a day, 4 times a day for 4 days. Evaluation will be done at the beginning of the study and every day for 4 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aydin Adnan Menderes University

Investigators

  • Study Director: Gülengün Türk, Prof.Dr, Aydın Adnan Menderes University, Faculty of Nursing, Department of Nursing Fundamentals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2021

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

July 2, 2021

First Submitted That Met QC Criteria

September 8, 2021

First Posted (Actual)

September 9, 2021

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Oral Care Frequency

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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