Effect of Nebulized Budesonide on Preventing Postextubation Complications in Critically Patients

Respiratory Sounds Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01786070
• Other study ID #: 390104
• Status: Recruiting
• Phase: N/A
• First received: February 2, 2013
• Last updated: February 5, 2013
• Start date: March 2011

Study information

• Verified date: February 2013
• Source: Isfahan University of Medical Sciences
• Contact: Saeed Abbasi, Assistant Professor
• Phone: 00989131135730
• Email: s_abbasi[@]med.mui.ac.ir
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Patients' age 18-55 years old

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:

1. Any history of corticosteroid therapy in previous week

2. Nasal or throat disease / surgery

3. Pulmonary airway disease

4. Gastrointestinal bleeding

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Respiratory Sounds

Intervention

Drug:
• Budesonide

• placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Alzahra University Hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post extubation stridor	Until 48 hours after extubation we documented if there is stridor in examination	After extubation until 48 hours	Yes