Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000373572
Ethics application status
Approved
Date submitted
13/01/2015
Date registered
23/04/2015
Date last updated
12/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of nebulized Budesonide on respiratory mechanics and oxygenation in patients with acute lung injury/acute respiratory distress syndrome: A prospective clinical study.
Scientific title
Effect of nebulized budesonide on respiratory mechanics and oxygenation in patients with acute lung injury/acute respiratory distress syndrome(ALI/ARDS).
Secondary ID [1] 285952 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute lung injury. 293879 0
Acute respiratory distress syndrome. 294668 0
Condition category
Condition code
Anaesthesiology 294180 294180 0 0
Other anaesthesiology
Respiratory 294181 294181 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
60 patients admitted to the ICU due to ALI/ARDS assigned to two groups:budesonide group(30 patients) where 1mg-2 ml budesonide suspension is nebulized through the endotracheal tube,while in the control group(30 patients) 2 ml isotonic saline is nebulized instead of budesonide.This regimen is applied twice daily for three successive days.Nebulization is performed using specific ventilator nebulized (Aeroneb pro-Aeroneb professional nebulized system Aerogen( Ireland) with an oxygen flow of 8 liters/ min. The duration of each Nebulization session is 15 minutes. before each session, recruitment manoeuvre is done by increasing peak airway so as to get a plateau pressure of 30 cm. H2o for 30 seconds.
Intervention code [1] 290923 0
Treatment: Drugs
Comparator / control treatment
Nebulized budesonide is being compared to nebulized saline in patients with ALI/ARDS
Control group
Placebo

Outcomes
Primary outcome [1] 293979 0
Pao2/fio2 ; it is calculated from the measured Pao2 ( from arterial blood gas analysis) and the inspired oxygen concentration. Fio2 is the inspired fraction of oxygen given by anesthesiologist whether pure oxygen(i.e 100% oxygen) or in combination with air(e.g. 60% oxygen in 40% air).
Timepoint [1] 293979 0
basal( before nebulization) and after termination of 6 nebulization sessions ( i.e after 72 hours) with either budesonide or isotonic saline.
Secondary outcome [1] 312271 0
Peak inspiratory pressure(PIP)- plateau pressure.
Both parameters are assessed from the screen of Binnette re spirometer.
Timepoint [1] 312271 0
basal( before nebulization) and after termination of 6 nebulization sessions( i.e after 72 hours) with either budesonide or isotonic saline.

Eligibility
Key inclusion criteria
Patients should fulfill the criteria of ALI/ARDS according to 2012 Berlin definition of ALI/ARDS
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Refusal of consent by relatives,age <18 or>65 years,chronic obstructive pulmonary disears,restrictive respiratory insufficiency,increased intracranial pressure, bronchpleural fistula,acute myocardial infarction and neuromuscular disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 6590 0
Egypt
State/province [1] 6590 0

Funding & Sponsors
Funding source category [1] 290539 0
University
Name [1] 290539 0
South valley university
Country [1] 290539 0
Egypt
Primary sponsor type
University
Name
South valley university
Address
South valley university-Qena-postal code 85823
Country
Egypt
Secondary sponsor category [1] 289231 0
Hospital
Name [1] 289231 0
Qena university hospital
Address [1] 289231 0
Qena university hospital-Qena-postal code 85823
Country [1] 289231 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294810 0
Ethics Committee of Qena university hospitals
Ethics committee address [1] 294810 0
Qena-P.O.83523
Ethics committee country [1] 294810 0
Egypt
Date submitted for ethics approval [1] 294810 0
04/12/2013
Approval date [1] 294810 0
03/01/2014
Ethics approval number [1] 294810 0
Not changed

Summary
Brief summary
We want to study the effect of nebulized budesonide on oxygenation and respiratory mechanics when used in conjunction with recruitment maneuver in patients with ALI/ARDS
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48554 0
Dr Hatem saber mohamed
Address 48554 0
Qena university hospital -Qena- postal code 85823
Country 48554 0
Egypt
Phone 48554 0
+201005257062
Fax 48554 0
Email 48554 0
[email protected]
Contact person for public queries
Name 48555 0
Dr Hatem saber mohamed
Address 48555 0
Qena university hospital-Qena-postal code 85823
Country 48555 0
Egypt
Phone 48555 0
+201005257062
Fax 48555 0
Email 48555 0
[email protected]
Contact person for scientific queries
Name 48556 0
A/Prof Salah mostafa asida
Address 48556 0
Qena university hospital-Qena-postal code 85823
Country 48556 0
Egypt
Phone 48556 0
+201005262075
Fax 48556 0
Email 48556 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of nebulized budesonide on respiratory mechanics and oxygenation in acute lung injury/acute respiratory distress syndrome: Randomized controlled study.2017https://dx.doi.org/10.4103/1658-354X.197369
N.B. These documents automatically identified may not have been verified by the study sponsor.