Protocol summary
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Study aim
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The primary end-point of this study was to investigate the incidence of sinusitis confirmed by imaging between the two treatment groups.
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Design
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Randomized, parallel, and open label trial
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Main outcome variable: Incidence of sinusitis confirmed by imaging
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2019-04-20, 1398/01/31
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2017-09-01, 1396/06/10
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Expected recruitment end date
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2018-09-30, 1397/07/08
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Use of azelastine and sodium chloride for prevention of sinusitis in ICU admitted patients
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Public title
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Prevention of sinusitis
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
126
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization was performed using the simple randomization method.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-08-01, 1396/05/10
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Ethics committee reference number
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IR.AJAUMS.REC.1396.72
Health conditions studied
1
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Description of health condition studied
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Sinusitis
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ICD-10 code
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J01
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ICD-10 code description
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Acute sinusitis
Primary outcomes
1
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Description
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The percentage of patients at the end of the study in both treatment and control groups with imaging confirmed sinusitis.
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Timepoint
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During 10 days of tial
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Method of measurement
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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
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Description
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Incidence of pneumonia
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Timepoint
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During the 10 days of study
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Method of measurement
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Evaluation by CPIS score
2
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Description
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Changes in CPIS score
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Timepoint
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During the 10 days of study
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Method of measurement
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Evaluation by CPIS score
3
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Description
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White blood cell changes in patients during the study
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Timepoint
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During the 10 days of study
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Method of measurement
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Laboratory examination of white blood cells
4
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Description
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Changes in patient body temperature during the study
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Timepoint
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During the 10 days of study
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Method of measurement
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Checking body temperature by digital thermometer
5
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Description
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Changes in tracheal and secretions of patients
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Timepoint
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During the 10 days of study
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Method of measurement
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Qualitative assessment by the doctor
6
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Description
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Evaluation of isolated organisms from the patient's’ tracheal secretions
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Timepoint
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During the 10 days of study
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Method of measurement
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Microbial culture of tracheal secretion
Intervention groups
1
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Description
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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.
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Category
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Prevention
2
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Description
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Control group: In the control group, routine care was performed for patients.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Artesh University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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This information is confidential and can not be provided
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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All available data will be provided
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When the data will become available and for how long
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starting 12 months after publication
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To whom data/document is available
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Academic staff and researchers
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Under which criteria data/document could be used
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No more permission will be given
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From where data/document is obtainable
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By email researcher
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What processes are involved for a request to access data/document
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Provide an explanation in the email for the reason for requesting information from the researcher
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Comments
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