Prevention of sinusitis
Phase 3
- Conditions
- Sinusitis.Acute sinusitis
- Registration Number
- IRCT20190312043037N1
- Lead Sponsor
- Artesh University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 126
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.