1. Home
  2. Approved trials
  3. » فارسی

Use of azelastine and sodium chloride for prevention of sinusitis in ICU admitted patients

View the latest revision

History
# Registration date Revision Id
2 2019-05-26, 1398/03/05 95131
1 2019-04-20, 1398/01/31 87111
Changes made to previous revision

  • Help:

    Red color represents old content. It may be empty showing addition in the new version.
    Green color represents new content. It may be empty showing deletion in the new version.

    Inline Side by side
    Added new contents, deleted old contents, contents that are not changed.
    New table contents New table contents
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    Added new contents, contents that are not changed.
    Deleted old contents, contents that are not changed.
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    New table contents New table contents
    Unchanged contents Unchanged contents

  • Protocol summary

    The primary end-point of this study was to investigate the incidence of sinusitis confirmed by imaging between the two treatment groups. The secondary end-points were to compare the incidence of pneumonia, changes in Clinical Pulmonary Infection score (CPIS), white blood cell (WBC), temperature, tracheal and nasal secretions and finally, the isolated organisms from the patients’ tracheal secretions.
    The primary end-point of this study was to investigate the incidence of sinusitis confirmed by imaging between the two treatment groups.
    هدف اولیه در این مطالعه بررسی بروز سینوزیت بین دو گروه درمانی می باشد که بوسیله تصویر برداری تایید شده باشد. اهداف ثانویه شامل بررسی میزان بروز پنومونی در بیماران، روند تغییرات شاخص CPIS، روند تغییرات WBC و temperature، ترشحات تراشه و بینی در بیماران در طی مدت مطالعه و در نهایت مقایسه ارگانیسم های جدا شده از ترشحات تراشه بیماران می باشد.
    هدف اولیه در این مطالعه بررسی بروز سینوزیت بین دو گروه درمانی می باشد که بوسیله تصویر برداری تایید شده باشد.
    Randomized, parallel, and double-blind trial
    Randomized, parallel, and open label trial
    تصادفی، دو بازویی، دو سوکور
    تصادفی، دو بازویی، بدون کورسازی
    The present randomized, parallel, and double-blind trial was conducted in patients admitted to ICU at Imam Reza Hospital between September 2017 to September 2018.
    The present randomized, parallel, and open label trial was conducted in patients admitted to ICU at Imam Reza Hospital between September 2017 to September 2018.
    مطالعه حاضر با طراحی تصادفی، دو بازویی، دو سوکور در بیماران بستری در ICU مدیکال بیمارستان امام رضا در بازه زمانی سپتامبر 2017 تا سپتامبر 2018 صورت پذیرفته است.
    مطالعه حاضر با طراحی تصادفی، دو بازویی، بدون کورسازی در بیماران بستری در ICU مدیکال بیمارستان امام رضا در بازه زمانی سپتامبر 2017 تا سپتامبر 2018 صورت پذیرفته است.
    Intervention group: In the treatment group for patients, every 12 hours, a buffet of 0.15% Azlestine spray and 0.65% sodium chloride per nostril are prescribed. Control group: In the control group, routine care was performed for patients.
    Intervention group: In the treatment group for patients, every 12 hours, a puff of 0.15% Azlestine spray and 0.65% sodium chloride per nostril are prescribed. Control group: In the control group, routine care was performed for patients.

  • General information

    Double blinded
    Not blinded
    1
    1
    Patients and the attending physician did not know any of the treatment groups
    بیماران و پزشک بررسی کننده هیچ یک از گروه های درمانی اطلاع نداشته اند

  • Secondary outcomes

    #1
    empty
    Incidence of pneumonia
    empty
    میزان بروز پنومونی در طی مطالعه
    empty
    During the 10 days of study
    empty
    در طی 10 روز مطالعه
    empty
    Evaluation by CPIS score
    empty
    ارزیابی توسط محاسبه شاخص CPIS
    #2
    empty
    Changes in CPIS score
    empty
    تغییرات شاخص CPIS
    empty
    During the 10 days of study
    empty
    در طی 10 روز مطالعه
    empty
    Evaluation by CPIS score
    empty
    بررسی توسط شاخص CPIS
    #3
    empty
    White blood cell changes in patients during the study
    empty
    تغییر گلبول های سفید بیماران در طی مطالعه
    empty
    During the 10 days of study
    empty
    در طول 10 روز مطالعه
    empty
    Laboratory examination of white blood cells
    empty
    بررسی آزمایشگاهی گلبول های سفید
    #4
    empty
    Changes in patient body temperature during the study
    empty
    تغییر دمای بدن بیماران در طی مطالعه
    empty
    During the 10 days of study
    empty
    در طول 10 روز مطالعه
    empty
    Checking body temperature by digital thermometer
    empty
    بررسی دمای بدن توسط دماسنج دیجیتال
    #5
    empty
    Changes in tracheal and secretions of patients
    empty
    بررسی تغییرات ترشحات تراشه و بینی بیماران
    empty
    During the 10 days of study
    empty
    در طول 10 روز مطالعه
    empty
    Qualitative assessment by the doctor
    empty
    ارزیابی کیفی توسط پزشک
    #6
    empty
    Evaluation of isolated organisms from the patient's’ tracheal secretions
    empty
    ارزیابی ارگانیزم های جدا شده از ترشحات تراشه بیمار
    empty
    During the 10 days of study
    empty
    در طول 10 روز مطالعه
    empty
    Microbial culture of tracheal secretion
    empty
    کشت میکروبی ترشحات تراشه

  • Intervention groups

    #1
    Intervention group: In the treatment group for patients, every 12 hours, a buffet of 0.15% Azlestine spray and 0.65% sodium chloride per nostril are prescribed.
    Intervention group: In the treatment group for patients, every 12 hours, a puff of 0.15% Azlestine spray and 0.65% sodium chloride per nostril are prescribed.

  • Recruitment centers

    #1
    Name of recruitment center - English: imam reza hospital
    Name of recruitment center - Persian: بیمارستان امام رضا
    Full name of responsible person - English: Ebrahim Hazrati
    Full name of responsible person - Persian: ابراهیم حضرتی
    Street address - English: AJA university of medical science, Etemad zadeh street, Fatemi street
    Street address - Persian: دانشگاه علوم پزشکی ارتش، خیابان فاطمی، خیابان اعتماد زاده
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1411718541
    Phone: +98 21 4382 2274
    Fax:
    Email: dr.hazrati.e@gmail.com
    Web page address:
    Name of recruitment center - English: Imam Reza hospital
    Name of recruitment center - Persian: بیمارستان امام رضا
    Full name of responsible person - English: Ebrahim Hazrati
    Full name of responsible person - Persian: ابراهیم حضرتی
    Street address - English: Artesh University of Medical Sciences, Etemadzadeh street, Fatemi street
    Street address - Persian: دانشگاه علوم پزشکی ارتش، خیابان فاطمی، خیابان اعتماد زاده
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1411718541
    Phone: +98 21 4382 2274
    Fax:
    Email: dr.hazrati.e@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Ebrahim Hazrati
    Full name of responsible person - Persian: ابراهیم حضرتی
    Street address - English: Etemad zadeh street, Fatemi street
    Street address - Persian: خیابات فاطمی، خیابان اعتماد زاده
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1411718541
    Phone: +98 21 4382 2274
    Fax:
    Email: dr.hazrati.e@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mostafa Shahrezayee
    Full name of responsible person - Persian: مصطفی شاهرضایی
    Street address - English: Etemadzadeh street, Fatemi street
    Street address - Persian: خیابان فاطمی، خیابان اعتماد زاده
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1411718541
    Phone: +98 21 4382 2274
    Fax:
    Email: moshahrezayee@yahoo.com
    Web page address:

Protocol summary

Study aim
The primary end-point of this study was to investigate the incidence of sinusitis confirmed by imaging between the two treatment groups.
Design
Randomized, parallel, and open label trial
Settings and conduct
The present randomized, parallel, and open label trial was conducted in patients admitted to ICU at Imam Reza Hospital between September 2017 to September 2018.
Participants/Inclusion and exclusion criteria
Patients aged more than 18 years during the first 24 hours after Nasogasteric (NG) tube insertion were randomized into either the treatment or control group. Patients with the following criteria were excluded from the study: trauma to the head and face or anatomical abnormalities preventing NG tube placement; history of sinusitis in the last three months; leukopenia (WBC <3500 / ml); coagulation disorders (Platelet<100000 / ml, International Normalized Ratio> 1.5 or Prothrombin time test more than two times higher than normal); the presence of a tumor in the patient's head and neck.
Intervention groups
Intervention group: In the treatment group for patients, every 12 hours, a puff of 0.15% Azlestine spray and 0.65% sodium chloride per nostril are prescribed. Control group: In the control group, routine care was performed for patients.
Main outcome variables
Main outcome variable: Incidence of sinusitis confirmed by imaging

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190312043037N1
Registration date: 2019-04-20, 1398/01/31
Registration timing: retrospective

Last update: 2019-06-30, 1398/04/09
Update count: 1
Registration date
2019-04-20, 1398/01/31
Registrant information
Name
amirebrahim miroliaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4347 3700
Email address
aam_thunderbird@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-01, 1396/06/10
Expected recruitment end date
2018-09-30, 1397/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Use of azelastine and sodium chloride for prevention of sinusitis in ICU admitted patients
Public title
Prevention of sinusitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged more than 18 years during the first 24 hours after Nasogasteric tube insertion were randomized into either the treatment or control group.
Exclusion criteria:
Trauma to the head and face or anatomical abnormalities preventing Nasogasteric tube placement. History of sinusitis in the last three months. Leukopenia (white blood cell<3500 / ml) Coagulation disorders (platelet<100000 / ml, International Normalized Ratio (INR)> 1.5 or Prothrombin time test (PTT) more than two times higher than normal) Presence of a tumor in the patient's head and neck
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 126
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was performed using the simple randomization method.
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
Ethics committee of Artesh University of Medical Sciences
Street address
Artesh University of Medical Sciences, Etemadzadeh street, Fatemi street
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2017-08-01, 1396/05/10
Ethics committee reference number
IR.AJAUMS.REC.1396.72

Health conditions studied

1

Description of health condition studied
Sinusitis
ICD-10 code
J01
ICD-10 code description
Acute sinusitis

Primary outcomes

1

Description
The percentage of patients at the end of the study in both treatment and control groups with imaging confirmed sinusitis.
Timepoint
During 10 days of tial
Method of measurement
Body temperature test using digital thermometer, laboratory test for white blood cell count, examination of throat secretions by the physician, and confirmation of diagnosis by Computed Tomography scan

Secondary outcomes

1

Description
Incidence of pneumonia
Timepoint
During the 10 days of study
Method of measurement
Evaluation by CPIS score

2

Description
Changes in CPIS score
Timepoint
During the 10 days of study
Method of measurement
Evaluation by CPIS score

3

Description
White blood cell changes in patients during the study
Timepoint
During the 10 days of study
Method of measurement
Laboratory examination of white blood cells

4

Description
Changes in patient body temperature during the study
Timepoint
During the 10 days of study
Method of measurement
Checking body temperature by digital thermometer

5

Description
Changes in tracheal and secretions of patients
Timepoint
During the 10 days of study
Method of measurement
Qualitative assessment by the doctor

6

Description
Evaluation of isolated organisms from the patient's’ tracheal secretions
Timepoint
During the 10 days of study
Method of measurement
Microbial culture of tracheal secretion

Intervention groups

1

Description
Intervention group: In the treatment group for patients, every 12 hours, a puff of 0.15% Azlestine spray and 0.65% sodium chloride per nostril are prescribed.
Category
Prevention

2

Description
Control group: In the control group, routine care was performed for patients.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Ebrahim Hazrati
Street address
Artesh University of Medical Sciences, Etemadzadeh street, Fatemi street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 4382 2274
Email
dr.hazrati.e@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mostafa Shahrezayee
Street address
Etemadzadeh street, Fatemi street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 4382 2274
Email
moshahrezayee@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Ebrahim Hazrati
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Etemadzadeh street, Fatemi street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 4382 2274
Email
dr.hazrati.e@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Ebrahim Hazrati
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Etemadzadeh street, Fatemi street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 4382 2274
Email
dr.hazrati.e@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Ebrahim Hazrati
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Etemadzadeh street, Fatemi Street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 4382 2274
Email
dr.hazrati.e@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
This information is confidential and can not be provided
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
All available data will be provided
When the data will become available and for how long
starting 12 months after publication
To whom data/document is available
Academic staff and researchers
Under which criteria data/document could be used
No more permission will be given
From where data/document is obtainable
By email researcher
What processes are involved for a request to access data/document
Provide an explanation in the email for the reason for requesting information from the researcher
Comments
Loading...