Oral Care Frequency in Mechanically Ventilated Patients

NCT05039593 | Completed DMC

• 1 other identifier: Oral Care Frequency
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Complications

Keywords

Oral care; Chlorhexidine; Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

first group

EXPERIMENTAL

The patients in the first group will be given oral care with 0.12% chlorhexidine twice a day.

Other: chlorhexidine

second group

EXPERIMENTAL

The patients in the second group will be given oral care with 0.12% chlorhexidine 3 times a day.

Other: chlorhexidine

third group

EXPERIMENTAL

The patients in the third group will be given oral care with 0.12% chlorhexidine 4 times a day.

Other: chlorhexidine

Interventions

chlorhexidine OTHER

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.

first group; second group; third group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydın Adnan Menderes University

Aydin, Efeler, 09100, Turkey (Türkiye)

Location

Related Publications (13)

• La Combe B, Maherault 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.

  PMID: 30247201 BACKGROUND

• 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.

  PMID: 27507174 BACKGROUND

• 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.

  PMID: 29744564 BACKGROUND

• Kocacal Guler E, Turk 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.

  PMID: 29907077 BACKGROUND

• 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.

  PMID: 27499527 BACKGROUND

• 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.

  PMID: 12425407 BACKGROUND

• Lee S, Lighvan NL, McCredie V, Pechlivanoglou P, Krahn M, Quinonez 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.

  PMID: 30850551 BACKGROUND

• 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.

  PMID: 30325851 BACKGROUND

• Ory J, Raybaud E, Chabanne R, Cosserant B, Faure JS, Guerin 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.

  PMID: 28341071 BACKGROUND

• 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.

  PMID: 25349099 BACKGROUND

• Turk G, Kocacal Guler 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.

  PMID: 22845634 BACKGROUND

• 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.

  PMID: 28320561 BACKGROUND

• 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. 2011 Sep;(106):92-8. French.

  PMID: 21972580 RESULT

MeSH Terms

Interventions

Chlorhexidine

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Gülengün Türk, Prof.Dr

  Aydın Adnan Menderes University, Faculty of Nursing, Department of Nursing Fundamentals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Model Details: 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.

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: September 9, 2021
• Study Start: July 5, 2021
• Primary Completion: June 1, 2022
• Study Completion: July 1, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)