Ignite Creation Date:
2024-05-06 @ 1:20 AM
Last Modification Date:
2024-10-26 @ 11:02 AM
Study NCT ID:
NCT01786070
Status:
UNKNOWN
Last Update Posted:
2013-02-07
First Post:
2013-02-02
Brief Title:
Effect of Nebulized Budesonide on Preventing Postextubation Complications in Critically Patients
Sponsor:
Isfahan University of Medical Sciences
Organization:
Isfahan University of Medical Sciences
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2013-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n35 and patients in placebo group receive placebo normal saline n35 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 248122436 and 48 hrs After extubation then the presence of stridor heard with the aid of stethoscope was recorded within 48 hr of extubation
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 n35 and patients in placebo group receive placebo normal saline n35 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 248122436 and 48 hrs After extubation then the presence of stridor heard with the aid of stethoscope was recorded within 48 hr of extubation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None