Ignite Creation Date:
2024-05-06 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05039593
Status:
COMPLETED
Last Update Posted:
2022-07-20
First Post:
2021-07-02
Brief Title:
Oral Care Frequency in Mechanically Ventilated Patients
Sponsor:
Aydin Adnan Menderes University
Organization:
Aydin Adnan Menderes University
Study Overview
Official Title:
The Effect of Oral Care Frequency on Oral Mucosa Membrane Integrity in Patients With Mechanical Ventilation Support
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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 wellInadequate oral care can negatively affect all these as well as cause problems such as dry mouth dental caries periodontal diseases bad breath and stomatitisTherefore 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 importantThe 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 patientsHowever 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 01062021 and 01062022 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 01062021 and 01062022 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 012 chlorhexidine solution will be used
The concentration of 012 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 012 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
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 importantThe 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 patientsHowever 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 01062021 and 01062022 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 01062021 and 01062022 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 012 chlorhexidine solution will be used
The concentration of 012 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 012 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None