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Prevention of sinusitis

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190312043037N1
Enrollment
126
Registered
2019-04-20
Start date
2017-09-01
Completion date
Unknown
Last updated
2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sinusitis. Acute sinusitis

Interventions

Intervention 1: 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. Intervention 2: Control g

Sponsors

Artesh University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion 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

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 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Incidence of pneumonia. Timepoint: During the 10 days of study. Method of measurement: Evaluation by CPIS score.;Changes in CPIS score. Timepoint: During the 10 days of study. Method of measurement: Evaluation by CPIS score.;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.;Changes in patient body temperature during the study. Timepoint: During the 10 days of study. Method of measurement: Checking body temperature by digital thermometer.;Changes in tracheal and secretions of patients. Timepoint: During the 10 days of study. Method of measurement: Qualitative assessment by the doctor.;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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactEbrahim Hazrati

Artesh University of Medical Sciences

dr.hazrati.e@gmail.com+98 21 4382 2274

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026