Comparison of the effect of 0.2% chlorhexidine solution and toothbrush in the prevention of oral lesions in intubated patients hospitalized in the intensive care unit
Comparison of the effect of 0.2% chlorhexidine solution and toothbrush in preventing oral lesions of intubated patients hospitalized in the intensive care unit.
Design
The present study is a randomized clinical trial with a sample size of 108 and permutation block method with a size of 6. Then the blocks are randomly numbered and selected, and the execution method based on the permutation within the block will be done.
Settings and conduct
The research population includes all patients admitted with a tracheal tube in the special care department of ICU A, ICU B, CCU A, CCU B, CCU C, CCU F, CCU G, CCU P of Shaheed Rajaie Cardiovascular Medical and Research Center .
Participants/Inclusion and exclusion criteria
Entry: Age above 18 years
Having an oral tracheal tube for at least 3 days
No wounds and severe injuries in the mouth
Not having hepatitis B disease
Not having HIV
Not having coagulation problems, not allergic to chlorhexidine
Not having artificial teeth
Exit:
Transfer of the patient from the intensive care unit during the study period
Death of the patient during the study
Allergic reaction
Limitations in performing the technique
Risk of aspiration
Unwillingness to continue the study on the part of the legal guardians of the patients
Perform tracheostomy during the study
Endotracheal tube extubation during the study period
Intervention groups
Group A: use of 0.2% chlorhexidine solution
Group B: Using a toothbrush
Group C: combined use of toothbrush and chlorhexidine mouthwash
Main outcome variables
If the appropriate method of preventing oral lesions in intubated patients hospitalized in the intensive care unit is determined, which method can provide a more positive result for the oral hygiene of the special unit patients, we can make our proposal for the oral hygiene of the intubated special unit patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230105057051N1
Registration date:2023-07-11, 1402/04/20
Registration timing:prospective
Last update:2023-07-11, 1402/04/20
Update count:0
Registration date
2023-07-11, 1402/04/20
Registrant information
Name
mahnaz shamseh
Name of organization / entity
Shahid Rajaei Cardiovascular medical & Research Center
Country
Iran (Islamic Republic of)
Phone
+98 66 3343 5542
Email address
mashamceh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-22, 1402/04/31
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of 0.2% chlorhexidine solution and toothbrush in the prevention of oral lesions in intubated patients hospitalized in the intensive care unit
Public title
Comparison of the effect of 0.2% chlorhexidine solution and toothbrush in the prevention of oral lesions in intubated patients hospitalized in the intensive care unit
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 18 years
Having an oral tracheal tube for at least 3 days
No wounds and severe injuries in the mouth
Not having hepatitis B disease
Not having HIV
Not having coagulation problems
Insensitivity to chlorhexidine
Not having artificial teeth
Exclusion criteria:
Transfer of the patient from the intensive care unit during the study period
Death of the patient during the study
Allergic reaction
Limitations in performing the technique
Risk of aspiration
Unwillingness to continue the study on the part of the legal guardians of the patients
Perform tracheostomy during the study
Endotracheal tube extubeation during the study period
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
The research population includes all patients admitted to the special care department of ICU A, ICU B, CCU A, CCU B, CCU C, CCU F, CCU G, CCU P with a tracheal tube. The researcher will select the patients who meet the study entry criteria. For random allocation of people, permutation block method with size 6 will be used. Then the blocks are randomly numbered and selected and the execution method based on the permutation within the block will be done.
Blinding (investigator's opinion)
Single blinded
Blinding description
The research population includes all patients admitted to the special care department of ICU A, ICU B, CCU A, CCU B, CCU C, CCU F, CCU G, CCU P with a tracheal tube. The researcher will select the patients who meet the study entry criteria. For random allocation of people, permutation block method with size 6 will be used. Then the blocks are randomly numbered and selected and the execution method based on the permutation within the block will be done. The participation of the patient will be voluntary and based on the informed consent of his legal guardian. In case of non-satisfaction, the transfer of the patient from the special care department, especially during the study period, the death of the patient during the study, the occurrence of an allergic reaction, the limitation in performing the technique, and the risk of aspiration will be excluded from the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shaheed Rajaie Cardiovascular Medical and Research Center
Street address
Vali Asr St. (AJ), next to Mellat Park, Niayesh corner
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2023-07-09, 1402/04/18
Ethics committee reference number
IR.RHC.REC.1402.030
Health conditions studied
1
Description of health condition studied
Oral lesions
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Oral hygiene method
Timepoint
It is done at 7:00 and 19:00 during 3 days (6 times in total)
Method of measurement
It is checked using BOAS and MPS tools and recorded in the checklist.
Secondary outcomes
1
Description
Oral health score
Timepoint
Intervention is done before each turn and recorded in the relevant checklist.
Method of measurement
It is checked using BOAS and MPS tools and recorded in the checklist.
Intervention groups
1
Description
Control group: Mouthwash group (group A) is performed with 0.2% chlorhexidine solution according to the routine method of the department. In this way, 10 ml of chlorhexidine is poured into a sterile receiver and the balled cotton is dipped in the chlorhexidine solution with a tweezer and the oral cavity, tongue and teeth are washed with the chlorhexidine solution. This procedure is performed at 7:00 a.m. and at 7:00 p.m. during 3 days (6 times in total) and checking with the BOAS and MPS tools is done before each mouthwash and is recorded in the relevant checklist.
Category
Prevention
2
Description
Intervention group: In group B, using a soft toothbrush with half a centimeter of fluoride toothpaste on it, first all the internal and external surfaces of the teeth and gums with rotating movements, and then the surfaces of the tongue and palate with Back and forth movements are brushed. After brushing, the mouth is rinsed and cleaned with normal saline. This procedure is performed at 7 am and 7 pm during 3 days (6 times in total). Checking with BOAS and MPS tools is done before each brushing session and is recorded in the relevant checklist.
Category
Prevention
3
Description
Intervention group: In group C (combined use of toothbrush and chlorhexidine mouthwash), at 7:00 a.m. and at 7:00 p.m. during 3 days (6 times in total), using a soft toothbrush and toothpaste containing fluoride, first all internal and external surfaces of the teeth and gums It is brushed with circular movements and then the surfaces of the tongue and palate are brushed with back and forth movements. After brushing, every part of the mouth is wet with normal saline, and the mouth is rinsed and cleaned with that. Then, 10 ml of chlorhexidine is poured into a sterile receiver and the balled cotton is soaked in the chlorhexidine solution with a tweezer and the mouth cavity, tongue and teeth are washed with the chlorhexidine solution. Checking with BOAS and MPS tools is done before each intervention with toothbrush and mouthwash and is recorded in the relevant checklist.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaheed Rajaie Cardiovascular Medical & Research Center
Full name of responsible person
mahnaz shamseh
Street address
Vali Asr St. (AJ), next to Mellat Park, Niayesh corner
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
mashamceh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shaheed Rajaie Cardiovascular Medical & Research Center
Full name of responsible person
Saeideh Mazloomzadeh
Street address
Vali Asr St. (AJ), next to Mellat Park, Niayesh corner
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 3982
Email
sa.mazloom@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shaheed Rajaie Cardiovascular Medical & Research Center
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shaheed Rajaie Cardiovascular medical & Research Center