Oral Care Frequency in Mechanically Ventilated Patients

Oral Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05039593
• Other study ID #: Oral Care Frequency
• Status: Completed
• Phase: N/A
• Start date: July 5, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: July 2022
• Source: Aydin Adnan Menderes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: July 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Oral Complications

Intervention

Other:
• chlorhexidine
The population of the research is the patients hospitalized in the Internal Medicine intensive care unit of Aydin 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.

Locations

Country	Name	City	State
Turkey	Aydin Adnan Menderes University	Aydin	Efeler

Sponsors (1)

Lead Sponsor	Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

References & Publications (13)

Bordenave C. [Evaluation of the effectiveness of a protocol of intensification of mouth care (teeth brushing and chlorhexidine 0.12%) on the colonisation of tracheal aspirations in intubated and ventilated patients in intensive care]. Rech Soins Infirm. 2 — View Citation

Deschepper M, Waegeman W, Eeckloo K, Vogelaers D, Blot S. Effects of chlorhexidine gluconate oral care on hospital mortality: a hospital-wide, observational cohort study. Intensive Care Med. 2018 Jul;44(7):1017-1026. doi: 10.1007/s00134-018-5171-3. Epub 2018 May 9. — View Citation

Haghighi A, Shafipour V, Bagheri-Nesami M, Gholipour Baradari A, Yazdani Charati J. The impact of oral care on oral health status and prevention of ventilator-associated pneumonia in critically ill patients. Aust Crit Care. 2017 Mar;30(2):69-73. doi: 10.1016/j.aucc.2016.07.002. Epub 2016 Aug 4. — View Citation

Houston S, Hougland P, Anderson JJ, LaRocco M, Kennedy V, Gentry LO. Effectiveness of 0.12% chlorhexidine gluconate oral rinse in reducing prevalence of nosocomial pneumonia in patients undergoing heart surgery. Am J Crit Care. 2002 Nov;11(6):567-70. — View Citation

Kocaçal Güler E, Türk G. Oral Chlorhexidine Against Ventilator-Associated Pneumonia and Microbial Colonization in Intensive Care Patients. West J Nurs Res. 2019 Jun;41(6):901-919. doi: 10.1177/0193945918781531. Epub 2018 Jun 15. — View Citation

La Combe B, Mahérault AC, Messika J, Billard-Pomares T, Branger C, Landraud L, Dreyfuss D, Dib F, Massias L, Ricard JD. Oropharyngeal Bacterial Colonization after Chlorhexidine Mouthwash in Mechanically Ventilated Critically Ill Patients. Anesthesiology. 2018 Dec;129(6):1140-1148. doi: 10.1097/ALN.0000000000002451. — View Citation

Lee S, Lighvan NL, McCredie V, Pechlivanoglou P, Krahn M, Quiñonez C, Azarpazhooh A. Chlorhexidine-Related Mortality Rate in Critically Ill Subjects in Intensive Care Units: A Systematic Review and Meta-Analysis. Respir Care. 2019 Mar;64(3):337-349. doi: 10.4187/respcare.06434. — View Citation

McCue MK, Palmer GA. Use of Chlorhexidine to Prevent Ventilator-Associated Pneumonia in a Long-term Care Setting: A Retrospective Medical Record Review. J Nurs Care Qual. 2019 Jul/Sep;34(3):263-268. doi: 10.1097/NCQ.0000000000000367. Review. — View Citation

Ory J, Raybaud E, Chabanne R, Cosserant B, Faure JS, Guérin R, Calvet L, Pereira B, Mourgues C, Guelon D, Traore O. Comparative study of 2 oral care protocols in intensive care units. Am J Infect Control. 2017 Mar 1;45(3):245-250. doi: 10.1016/j.ajic.2016.09.006. Epub 2016 Oct 27. — View Citation

Saddki N, Mohamad Sani FE, Tin-Oo MM. Oral care for intubated patients: a survey of intensive care unit nurses. Nurs Crit Care. 2017 Mar;22(2):89-98. doi: 10.1111/nicc.12119. Epub 2014 Oct 28. — View Citation

Türk G, Kocaçal Güler E, Eser I, Khorshid L. Oral care practices of intensive care nurses: a descriptive study. Int J Nurs Pract. 2012 Aug;18(4):347-53. doi: 10.1111/j.1440-172X.2012.02045.x. — View Citation

Villar CC, Pannuti CM, Nery DM, Morillo CM, Carmona MJ, Romito GA. Effectiveness of Intraoral Chlorhexidine Protocols in the Prevention of Ventilator-Associated Pneumonia: Meta-Analysis and Systematic Review. Respir Care. 2016 Sep;61(9):1245-59. doi: 10.4187/respcare.04610. Epub 2016 Aug 9. — View Citation

Zand F, Zahed L, Mansouri P, Dehghanrad F, Bahrani M, Ghorbani M. The effects of oral rinse with 0.2% and 2% chlorhexidine on oropharyngeal colonization and ventilator associated pneumonia in adults' intensive care units. J Crit Care. 2017 Aug;40:318-322. doi: 10.1016/j.jcrc.2017.02.029. Epub 2017 Mar 1. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral mucosal evaluation of patients.	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.