Effect of Nebulized Budesonide on Preventing Postextubation Complications in Critically Patients

NCT01786070 | Unknown

• 1 other identifier: 390104
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Sounds

Outcome Measures

Primary Outcomes (1)

• post extubation stridor

  Until 48 hours after extubation we documented if there is stridor in examination

  After extubation until 48 hours

Study Arms (2)

Budesonide

ACTIVE COMPARATOR

Budesonide : 1 mg/4ml every 12 hrs for 48 hrs

Drug: Budesonide

Placebo

PLACEBO COMPARATOR

Normal saline at an equivalent volume (4 ml every 12 hrs for 48 hrs)

Drug: placebo

Interventions

Budesonide DRUG

Budesonide

placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any history of corticosteroid therapy in previous week
• Nasal or throat disease / surgery
• Pulmonary airway disease
• Gastrointestinal bleeding

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Alzahra University Hospital

Isfahan, Isfahan, Iran

RECRUITING

MeSH Terms

Conditions

Respiratory Sounds

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Saeed Abbasi, Assistant Professor

CONTACT

00989131135730; s_abbasi@med.mui.ac.ir

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Anesthesiology

Study Record Dates

• First Submitted: February 2, 2013
• First Posted: February 7, 2013
• Study Start: March 1, 2011
• Primary Completion: March 1, 2014
• Last Updated: February 7, 2013

Record last verified: 2013-02

Locations

IR (1)