Effect of Nebulized Budesonide on Preventing Postextubation Complications in Critically Patients
NCT ID: NCT01786070
Last Updated: 2013-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
70 participants
INTERVENTIONAL
2011-03-31
Brief Summary
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In this double-blind randomized clinical trial study, 70 patients (age between 18 to 65) who are intubated (at least for 48 hours) and now are ready for extubation will be enrolled in the study after obtaining a written informed consent from their parents or guardians.
The investigators divide our patients randomly into two equal groups.
-Patients who are in budesonide group will receive nebulized budesonide (1 mg-every 12 hours; n=35) and patients in placebo group receive placebo (normal saline; n=35) until 48 hours after extubation. If patient have extubation criteria the investigators will extubate him and for 24 hours after, another anesthesiologist who is unaware about kind of medication, will evaluate the patients for severity of stridor. We will record the vital sings and grade of stridor every 6 hour. Respiratory rate (RR), heart rate (HR), blood pressure (BP) and oxygen saturation (SPO2) were recorded for each patient immediately before aerosol administration (time 0) and at 30 and 60 min; and 2,4,8,12,24,36 and 48 hrs. After extubation then the presence of stridor (heard with the aid of stethoscope) was recorded within 48 hr of extubation.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Budesonide
Budesonide : 1 mg/4ml every 12 hrs for 48 hrs
Budesonide
Placebo
Normal saline at an equivalent volume (4 ml every 12 hrs for 48 hrs)
placebo
Interventions
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Budesonide
placebo
Eligibility Criteria
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Inclusion Criteria
2. Intubated for more than 48 hours after surgery
3. Met the weaning criteria defined as respiratory rate \< 30 breaths / min, negative tidal volume \> 5 ml/kg ideal body weight, and shallow index (respiratory rate/tidal volume) \< 105 breaths / min/L
Exclusion Criteria
2. Nasal or throat disease / surgery
3. Pulmonary airway disease
4. Gastrointestinal bleeding
18 Years
65 Years
ALL
No
Sponsors
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Isfahan University of Medical Sciences
OTHER
Responsible Party
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Saeed Abbasi
Assistant Professor in Anesthesiology
Locations
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Alzahra University Hospital
Isfahan, Isfahan, Iran
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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390104
Identifier Type: -
Identifier Source: org_study_id
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