The effect of oral care using Artificial saliva to control dry mouth in patients with COVID-19 under non-invasive mechanical ventilation: A quasi-experimental study
The effect of oral care using Artificial saliva to control dry mouth in patients with COVID-19 under non-invasive mechanical ventilation
Design
Clinical trial with control group, parallel groups, without blinding, non-randomised, phase 3 on 80 patients.
Settings and conduct
In Labbafinejad Hospital, the sampler will be present in the intensive care unit of COVID- 19 patients. In addition to routine care, this hospital also uses artificial saliva 3 times a day. The other person will be present at Modares Hospital at the same time. In both hospitals, on the first day of patients' use of non-invasive mechanical ventilation, demographic information and the results of the initial assessment of patients' mouths will be recorded, then each patient will be examined daily for three days.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients admitted to the intensive care unit with COVID-19 (having a CT scan or positive PCR test), age over 18 years.
Criteria for not entering: Patients taking salivary-lowering drugs or those with systemic glandular disease Saliva, patients with obvious oral lesions, pests.
Intervention groups
In both hospitals, on the first day of patients' use of non-invasive mechanical ventilation, demographic information and the results of the initial oral assessment of patients will be recorded, then each patient for Three days will be examined daily and the oral condition of patients in both hospitals will be evaluated. Examination and evaluation of patients's mouth, in 4 stages including (day zero: before the start of non-invasive mechanical ventilation, first day: one day after the use of non-invasive mechanical ventilation until the third day (3 days after the use of non-invasive mechanical ventilation) Will be done.
Main outcome variables
Dry mouth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220223054107N1
Registration date:2022-02-25, 1400/12/06
Registration timing:prospective
Last update:2022-02-25, 1400/12/06
Update count:0
Registration date
2022-02-25, 1400/12/06
Registrant information
Name
sorour khari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8879 2453
Email address
sorour.khari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-01, 1400/12/10
Expected recruitment end date
2022-08-21, 1401/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral care using Artificial saliva to control dry mouth in patients with COVID-19 under non-invasive mechanical ventilation: A quasi-experimental study
Public title
The effect of oral care using Artificial saliva to control dry mouth in patients with COVID-19 under non-invasive mechanical ventilation: A quasi-experimental study
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients admitted to the intensive care unit with COVID- 19 (having a CT scan or positive PCR test) under non-invasive mechanical ventilation
age over 18 years
Patients with similar mechanical ventilation settings
Exclusion criteria:
Patients taking drugs associated with decreased salivary function.
Patients with obvious oral lesions, pest
Pregnant patients
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-Chancellor in Research Affairs - Shahid Beheshti University of Medical Sciences
Examination and evaluation of patients' mouths in 4 stages including (day zero: before the start of non-invasive mechanical ventilation, first day: one day after the use of non-invasive mechanical ventilation until the third day (3 days after the use of non-invasive mechanical ventilation) .
Method of measurement
Beck Oral Assessment Scale (BOAS) Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: This group receives only routine care (Chlorhexidine mouthwash 0.2% and normal saline) .
Category
Prevention
2
Description
Intervention group: In this group, in addition to routine care (Chlorhexidine mouthwash 0.2% and normal saline), mucosamin synthetic saliva spray is also used 3 times a day for 3 days. Initially, on the first day of patients with COVID-19 use of non-invasive mechanical ventilation, demographic information and the results of the initial oral assessment of patients will be recorded, then the patient's oral condition will be examined daily for three days. Examination and evaluation of patients's mouth, in 4 stages including (day zero: before the start of non-invasive mechanical ventilation, first day: one day after the use of non-invasive mechanical ventilation until the third day (3 days after the use of non-invasive mechanical ventilation) Will be done by the Oral Dryness Scale (BOAS).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Labbafinezhad Hospital
Full name of responsible person
Dr. Mohammad Hossein Soltani
Street address
Tehran, 9th Boostan St.
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 23601
Email
labafinejad.hos@tamin.ir
2
Recruitment center
Name of recruitment center
Modarres Hospital
Full name of responsible person
Dr. Saeed Alipour Parsa
Street address
Kaj Sq., Sadat Abad St., Tehran
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
modarres@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Yaman St, Parvaneh St., Next to Taleghani Hospital, Chamran High Way, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sorour Khari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr St., Niayesh Highway Intersection, School of Midwifery Nursing Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
sorourkhari71@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ladan Sedighi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Valiasr St., Niayesh Highway Intersection, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
l.sedighie@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sorour Khari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr St., Niayesh Highway Intersection, School of Midwifery Nursing Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
Email
sorourkhari71@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available