Determining the effect of multiple nursing interventions on the incidence of pneumonia -dependent stroke
Design
The randomized clinical trial with intervention and control groups was used for randomization from the randomization site.
Settings and conduct
Department of Neurology, Ali Bin Abitalib Hospital affiliated to Zahedan University of Medical Sciences
from the time of patient admission and taking into account the entry criteria in eligible patients for four consecutive days and at least twice a day
After the implementation of the mentioned care package, the symptoms including the presence or absence of fever, cough, changes in the number of white blood cells and the final diagnosis of the neurologist will be examined by the relevant tools and finally the occurrence of this complication will be announced by him.
Participants/Inclusion and exclusion criteria
Detecting confirmation of ischemic stroke by a specialist physician,
Moderate or intense dysphagia in accordance with the GUSS(Gugging Swallowing Screen) tool;Age older than 18, 24 hours after the onset of ischemic stroke symptoms, National Institutes of Health Stroke Scale(NIHSS) score above 3,Direct acceptance of the patient from the emergency department or the patient's direct referral to the doctor's office;The presence of pneumonia before hospitalization, Patients with liver and kidney failure, Allergies to chlorhexidine, Oral surgery, Patients with immune system suppression, Any malnutrition, Dissatisfaction to participate in the study
Intervention groups
In this study of two tools including GUSS for dysphagia and The International Dysphasia Diet Standardization Initiative(IDDSI) to provide a diet based on the intensity of dysphagia; And the oral care checklist will be used in the patients' patients. The control group will receive the usual sector care.
Main outcome variables
Stroke related pneumonia
General information
Reason for update
Acronym
SAP
IRCT registration information
IRCT registration number:IRCT20240212060983N1
Registration date:2024-05-23, 1403/03/03
Registration timing:registered_while_recruiting
Last update:2024-05-23, 1403/03/03
Update count:0
Registration date
2024-05-23, 1403/03/03
Registrant information
Name
Asma Rostami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 0566
Email address
nrsasma1155@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Multiple Nursing Interventions on the Incidence of Stroke Associated Pneumonia in Patients
Public title
Investigating the effect of multiple nursing interventions on ischemic stroke-related pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Detecting confirmation of ischemic stroke by a specialist physician
Moderate or intense dysphagia (in accordance with the GUSS tool score 0-14)
Age older than 18
24 hours after the onset of ischemic stroke symptoms
NIHSS score above 3
Direct acceptance of the patient from the emergency department or the patient's direct referral to the doctor's office and then referred to the department
Exclusion criteria:
Presence of pneumonia before hospitalization
Patients with liver and kidney failure
Infectious patients
Patients in need of specialized oral care and evaluation
Allergy to chlorhexidine
Oral surgery
Gum diseases
Infectious diseases of the mouth
Patients with immunosuppression
Having any malignancy
Lack of consent to participate in the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients are divided into two control and intervention groups based on the random assignment of quadruple blocks; Regarding the equal placement of the samples in the two control and intervention groups, a limited randomization method called blocking was used. This method helps this study so that in cases where intermediate analyzes are needed during the sampling process, the number of samples allocated to each of the studied groups is equal. In this study, the size of all blocks is equal. In this study, online randomization was used to generate random sequences. The decision to accept or reject participation in the study is made first and the informed consent form is completed, and then the participants are randomly assigned to each group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Joint Organizational Ethics Committee of Nursing and Midwifery Faculty and Rehabilitation Faculty of
Street address
No.4, Mazari 19, Mazari Boulevard
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817747843
Approval date
2024-01-30, 1402/11/10
Ethics committee reference number
IR.TUMS.FNM.REC.1402.197
Health conditions studied
1
Description of health condition studied
Ischemic stroke
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Stroke-related pneumonia
Timepoint
Before the implementation of the intervention and then 4 days after the end of the intervention
Method of measurement
Ischemic stroke-related pneumonia instrument
Secondary outcomes
empty
Intervention groups
1
Description
In order to collect the necessary data for the study, three tools and a checklist will be used; With the help of these tools and checklist, patients' conditions are accurately evaluated and then based on the results, appropriate nursing care is provided for each patient's condition. Tool number one (GUSS) consists of two tests; The test starts with swallowing saliva and then continues with swallowing semi-solid, liquid and solid tissues respectively. Instrument number two (IDDSI) consists of two components: food and beverage component; The nutritional strategy will be chosen by the nurse based on the severity of dysphagia, for example, in moderate dysphagia, feeding will be through a nasogastric tube and the use of pureed food, and in severe dysphagia, the patient will be given fasting and supplements through a nasogastric tube. will be. Oral care will be done using a ten-step checklist. In this study, nursing interventions to affect the occurrence of pneumonia related to ischemic stroke will include the examination of the severity of dysphagia, strategies related to diet and oral care methods in this group of patients after a detailed evaluation of the parameters of the tools and the above checklist. After the implementation of the mentioned care package, in this study, in order to evaluate stroke-related pneumonia, the developed symptoms include the presence or absence of fever, cough and white blood cells equal to and greater than 10x109 per liter or white blood cells equal to and smaller than 4 x 109 per liter and the final diagnosis of the neurologist will be examined by the stroke-related pneumonia tool and finally the occurrence of SAP will be announced by him.
Category
Prevention
2
Description
Control group: will receive routine ward care for four consecutive days.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ibn Abi Talib hospital
Full name of responsible person
Kaveh Yazdani
Street address
Ali Ibn Abitalib Hospital,Major General Mohammad Mir St., Persian Gulf Highway
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3337 2151
Email
info@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali akbari Sari
Street address
6th floor, Central Organization of Tehran University of Medical Sciences, corner of Qods St.,Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Email
rmo@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Asma Rostami
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 4, Mazari 19, Mazari Mazari Boulevard
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817747843
Phone
+98 54 3344 0566
Email
nrsasma1155@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Esmaeili
Position
Full Professor
Latest degree
Medical doctor
Other areas of specialty/work
Nursery
Street address
Dr. Mirkhani Ave. (East Nosrat), Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
mesmaeilie77@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Asma Rostami
Position
Master's Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 4, Mazari 19, Mazari Boulevard
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817747843
Phone
+98 54 3344 0566
Email
nrsasma1155@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