Investigating the Impact of Applying Ipratropium Bromide Inhalation on Cough Following Bronchoscopy in Children
Design
the collection of data is known as the field and the questionnaire and interview are used. That way, 60 qualified children are tested using the permutation blocks to two testing and control groups, 30 in the test group and 30 in the control group.
Settings and conduct
This study is a clinical trial without blindness. The study is conducted on the children of the educational and therapeutic center of namazi affiliated to the Shiraz University of Medical Sciences. The population studied by the children referred to the Shiraz namazi Hospital under the auspices of Bronchoscopy
Participants/Inclusion and exclusion criteria
The inclusion criteria include the age between 2 and 12 years and under Bronchoscopy .
The exit criteria include the use of inhalation and oral corticosteroids, heart disease, drug sensitivity, and the existence of smoking and smoking in the family
Intervention groups
The control group is placed under standard care and medication before and after treatment, and in addition to the standard care group, 2 for 3 minutes for the 3 dose of inhalation bromide by damyar, the control group will be carried out by damyar an hour before and the control group is interviewed in terms of the extent of the coughing.
Main outcome variables
number and severity of cough, respiratory rate, heart rate and blood pressure, need for suction during surgery and after entering recovery
General information
Reason for update
Acronym
SIIBCS
IRCT registration information
IRCT registration number:IRCT20211028052894N1
Registration date:2022-06-13, 1401/03/23
Registration timing:registered_while_recruiting
Last update:2022-06-13, 1401/03/23
Update count:0
Registration date
2022-06-13, 1401/03/23
Registrant information
Name
Mohamad amin Tavazo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3632 1496
Email address
ehsantavazo@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-26, 1400/12/07
Expected recruitment end date
2022-07-29, 1401/05/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Impact of Applying Ipratropium Bromide Inhalation on Cough Following Bronchoscopy in Children
Public title
Investigating the Impact of Applying Ipratropium Bromide Inhalation on Cough Following Bronchoscopy in Children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The inclusion criteria include the age between 2 and 12 years
The inclusion under Bronchoscopy
Exclusion criteria:
The exit criteria include the use of Inhalation and oral corticosteroids, heart disease, drug sensitivity,
and the existence of smoking and smoking in
Age
From 2 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
the data collection method is a field and questionnaire and interview is used. In this study, children in this study will be divided into two testing and control groups, 30 in the test group and 30 in the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
according to the limited society and lack of similar study, the pilot sampling method is used to determine sample size, as it is intended for the control group of 30 and for the test group of 30.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
west sheykhi
City
shiraz
Province
Fars
Postal code
7185998181
Approval date
2021-10-20, 1400/07/28
Ethics committee reference number
IR.SUMS.MED.REC.1400.380
Health conditions studied
1
Description of health condition studied
Investigating the Impact of Applying Ipratropium Bromide Inhalation on Reducing Cough Following Bronchoscopy in Children
ICD-10 code
0BJ08ZZ
ICD-10 code description
Inspection of Tracheobronchial Tree, Via Natural or Artificial Opening Endoscopic
Primary outcomes
1
Description
number cough
Timepoint
The recovery and immediately after the patient " s arrival at the recovery, then every 30 minutes will be assessed number of coughs .
Method of measurement
count number of coughs by nurse
Secondary outcomes
1
Description
Respiratory rate
Timepoint
During and immediately after finishing the work and entering the patient to the recovery is remembered every 30 minutes
Method of measurement
Measures and notes at the specified times by the nurse
2
Description
Heart rate
Timepoint
During and immediately after finishing the work and entering the patient to the recovery is remembered every 30 minutes
Method of measurement
Measures and notes at the specified times by the nurse
3
Description
Blood pressure
Timepoint
During and immediately after finishing the work and entering the patient to the recovery is remembered every 30 minutes
Method of measurement
Measures and notes at the specified times by the nurse
4
Description
The need for suctioning
Timepoint
During and immediately after finishing the work and entering the patient to the recovery is remembered every 30 minutes
Method of measurement
Measures and notes at the specified times by the nurse
Intervention groups
1
Description
Intervention group: First, 30 eligible kindergartens will be selected as the intervention group using permutation blocks. In addition to standard care, 2 puffs will be performed every 20 minutes for 3 ipratropyum bromide inhaled by Demiar one hour before surgery and will be interviewed and observed in terms of coughing rate.For this purpose, a nurse colleague without knowing the prescription of the drug is requested to remember the severity and number of coughs, the number of breathing, heart rate and blood pressure of the patient at the specified times during and immediately after the completion of the work and the patient's entry into the recovery every 30 minutes. Also, the need for suctioning during surgery and after the patient's arrival to recovery at similar times should be remembered.
Category
Treatment - Drugs
2
Description
Control group: 30 eligible kindergartens will be selected as the control group using permutation blocks, the control group will be treated with standard care and medications before, during and after bronchoscopy and will be interviewed and observed in terms of cough rate. For this purpose, a nurse colleague is requested without the knowledge of the prescription of the drug.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Mohammad Ashkan Moslehi
Street address
West Zand; Namazi Hospital
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Fax
+98 71 3647 4326
Email
namazee_inf@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamid Mohammdi
Street address
West Zand ; West Felestin ;organization central shiraz univercity
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Amin Tavazo
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
West Shykhi 4 Alley
City
Shiraz
Province
Fars
Postal code
7185998181
Phone
+98 71 3632 1496
Email
mohammad.amin.tavazo.1990@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Amin Tavazo
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
West Sheykhi 4alley
City
Shiraz
Province
Fars
Postal code
7185998171
Phone
+98 71 3632 1496
Email
mohammad.amin.tavazo.1990@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohamm Amin Tavazo
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
West Sheykhi 4alley
City
Shiraz
Province
Fars
Postal code
7185998181
Phone
+98 71 3632 1496
Email
mohammad.amin.tavazo.1990@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
no data
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
no data
When the data will become available and for how long
no data
To whom data/document is available
no data
Under which criteria data/document could be used
no data
From where data/document is obtainable
no data
What processes are involved for a request to access data/document