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.
Design
Randomized, parallel, and double-blind trial
Settings and conduct
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.
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 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.
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:2019-04-20, 1398/01/31
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
Participant
Investigator
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)
Double blinded
Blinding description
Patients and the attending physician did not know any of the treatment groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Aja University of Medical Sciences
Street address
AJA university of medical science, Etemad zadeh 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
empty
Intervention groups
1
Description
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.
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
AJA university of medical science, Etemad zadeh 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
Ebrahim Hazrati
Street address
Etemad zadeh street, Fatemi street
City
tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 4382 2274
Email
dr.hazrati.e@gmail.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