Effect of Nebulized Budesonide on Preventing Postextubation Complications in Critically Patients
Primary Purpose
Respiratory Sounds
Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Budesonide
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Sounds
Eligibility Criteria
Inclusion Criteria:
- Patients' age 18-55 years old
- Intubated for more than 48 hours after surgery
- 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:
- Any history of corticosteroid therapy in previous week
- Nasal or throat disease / surgery
- Pulmonary airway disease
- Gastrointestinal bleeding
Sites / Locations
- Alzahra University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Budesonide
Placebo
Arm Description
Budesonide : 1 mg/4ml every 12 hrs for 48 hrs
Normal saline at an equivalent volume (4 ml every 12 hrs for 48 hrs)
Outcomes
Primary Outcome Measures
post extubation stridor
Until 48 hours after extubation we documented if there is stridor in examination
Secondary Outcome Measures
Full Information
NCT ID
NCT01786070
First Posted
February 2, 2013
Last Updated
February 5, 2013
Sponsor
Isfahan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01786070
Brief Title
Effect of Nebulized Budesonide on Preventing Postextubation Complications in Critically Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences
4. Oversight
5. Study Description
Brief Summary
The aim of this study is evaluation of the effect of administration nebulized budesonide after extubation. The specific objectives of our study are to determine whether multiple doses of nebulized budesonide are effective to reduce or prevent postextubation edema.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Sounds
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Budesonide
Arm Type
Active Comparator
Arm Description
Budesonide : 1 mg/4ml every 12 hrs for 48 hrs
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline at an equivalent volume (4 ml every 12 hrs for 48 hrs)
Intervention Type
Drug
Intervention Name(s)
Budesonide
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
post extubation stridor
Description
Until 48 hours after extubation we documented if there is stridor in examination
Time Frame
After extubation until 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients' age 18-55 years old
Intubated for more than 48 hours after surgery
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:
Any history of corticosteroid therapy in previous week
Nasal or throat disease / surgery
Pulmonary airway disease
Gastrointestinal bleeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Saeed Abbasi, Assistant Professor
Phone
00989131135730
Email
s_abbasi@med.mui.ac.ir
Facility Information:
Facility Name
Alzahra University Hospital
City
Isfahan
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saeed Abbasi, Assistant Professor
Phone
00989131135730
Email
s_abbasi@med.mui.ac.ir
12. IPD Sharing Statement
Learn more about this trial
Effect of Nebulized Budesonide on Preventing Postextubation Complications in Critically Patients
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