Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000836730
Ethics application status
Approved
Date submitted
21/07/2013
Date registered
30/07/2013
Date last updated
30/07/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Albuterol for Acute Lung Injury
Scientific title
lung recruitment maneuver with and without nebulized albuterol for acute lung injury, randomized controlled study
Secondary ID [1] 282872 0
NIL
Universal Trial Number (UTN)
U1111-1145-8590
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
we will study the effect of adding aerosolized albuterol to lung recruitment maneuver during the managment of ALI due to surgical and non-surgical causes e.g acute lung injury following aspiration pneumonia , abdominal sepsis, pancreatitis, chest trauma , lobectomy,and so on 289690 0
Condition category
Condition code
Anaesthesiology 290009 290009 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
we will test the value of adding aerosolized albuterol sulphate 5mg dissolved in 10 ml sterile saline and nebulised by connecting the nebulizer to the endotracheal tube during mechanical ventilation of patients with acute lung injury (ALI) together with lung recruitment maneuver which is done in the form of increasing the positive end expiratory pressure (PEEP) 10 cm H2O above the lower infliction point for 15 minutes or 10 cmH2O above the pre-recruitment PEEP to be repeated every four hours for five to seven successive days in a trial to improve alveolar fluid clearance and improve oxygenation in these patients
Intervention code [1] 287574 0
Treatment: Drugs
Comparator / control treatment
the control treatment is Placebo (Saline) 10ml nebulised by connecting the nebulizer to the endotracheal tube during mechanical ventilation of patients with ALI together with lung recruitment maneuver).
Control group
Placebo

Outcomes
Primary outcome [1] 290056 0
aveolar fluid clearance measured by protein concentration in alveolar fluid lavage in broncho-alveolar samples will be collected just before RM. and ,1 and 4 hours after RM using A 14 –French 51 cm catheter passed through the endotracheal tube and wedged into the distal airway with contentious suction was applied to it (-400 cm) to obtain edema fluid at least 1 ml which was collected in a sterile Eppendorf tube for immediate analysis ( Eppendorf SA, Hamburg , Germany) in the clinical pathology Lab.
Timepoint [1] 290056 0
alveolar fluid samples will be withdrawn before recruitment maneuver , one hour after recruitment maneuver and four hours after recruitment maneuver and sent to the lab for protein concentration measurement
Secondary outcome [1] 303846 0
mean arterial oxygen tension will be measured by arterial blood sample from the radial artery
Timepoint [1] 303846 0
arterial blood gas (ABG) sample analysis is done just before lung recruitment maneuver , one and four hours after lung recruitment maneuver

Eligibility
Key inclusion criteria
patients with acute lung injury due to surgical and non surgical causes
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
hemodynamic instability , patients on b-blockers therapy

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)
enrolling according to computer generated table. allocating the treatment by closed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
generating sequence of randomsation according to graphpad software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
sample size was put according to assumption based on previously published data as a 10% change of protein concentration in alveolar fluid lavage samples will be considered 80% suffecient power this study

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/07/2013
Actual
20/07/2013
Date of last participant enrolment
Anticipated
20/12/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 5235 0
Egypt
State/province [1] 5235 0
Qena

Funding & Sponsors
Funding source category [1] 287654 0
University
Name [1] 287654 0
south valley university
Country [1] 287654 0
Egypt
Funding source category [2] 287657 0
Hospital
Name [2] 287657 0
Qena university hospital
Country [2] 287657 0
Egypt
Primary sponsor type
University
Name
south valley university
Address
South Valley University. P.O. 83523. Qena.
Country
Egypt
Secondary sponsor category [1] 286395 0
Hospital
Name [1] 286395 0
Anaesthesia Department. Qena University Hospital. p.o. 83523. Qena.
Address [1] 286395 0
Qena
Country [1] 286395 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289621 0
Qena faculty of medicine ethics committee
Ethics committee address [1] 289621 0
South valley university - Qena faculty of medicine , Qena .PO 83523
Ethics committee country [1] 289621 0
Egypt
Date submitted for ethics approval [1] 289621 0
05/07/2013
Approval date [1] 289621 0
20/07/2013
Ethics approval number [1] 289621 0

Summary
Brief summary
the study will test the value of adding aerosolized albuterol to lung recruitment during mechanical ventilation of patients with ALI to improve alveolar fluid clearance and oxygenation
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41610 0
A/Prof salah mostafa asida
Address 41610 0
anaethesia department , Qena university hospital , PO 83523 Qena.
Country 41610 0
Egypt
Phone 41610 0
+201005262075
Fax 41610 0
Email 41610 0
[email protected]
Contact person for public queries
Name 41611 0
A/Prof salah mostafa asida
Address 41611 0
anaesthesia department - Qena university hospital PO 83523 Qena
Country 41611 0
Egypt
Phone 41611 0
+201005262075
Fax 41611 0
Email 41611 0
[email protected]
Contact person for scientific queries
Name 41612 0
A/Prof salah mostafa asida
Address 41612 0
anaesthesia department -Qena university hospital- P.O. 83523 Qena
Country 41612 0
Egypt
Phone 41612 0
+2 01005262075
Fax 41612 0
Email 41612 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
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