Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000100695
Ethics application status
Not yet submitted
Date submitted
17/01/2014
Date registered
28/01/2014
Date last updated
28/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
the effect of using low tidal volume during general anaesthesia while putting the patient in the lateral position on lung functions
Scientific title
Effect of low tidal volume during general anaesthesia for urological procedures on lung functions
Secondary ID [1] 283927 0
nil
Universal Trial Number (UTN)
U1111-1152-2774
Trial acronym
GALP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
the effect of using low tidal volume on lung functions during general anaesthesia while the patient laying in the lateral position 290933 0
Condition category
Condition code
Anaesthesiology 291289 291289 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
we are planning to study the effect of using tidal volume of 6 ml/kg during general anaesthesia for patients put in the left or right lateral position for more than or at least 2 hours urosurgical operations.this is to be compared with using tidal volume of 10-12 ml/kg . pre- and post-operative lung functions will be measured and compared
Intervention code [1] 288616 0
Treatment: Other
Comparator / control treatment
we will compare low tidal volume (6ml/kg)with conventional( control) tidal volume (10-12 ml/kg)
Control group
Active

Outcomes
Primary outcome [1] 291284 0
postoperative lung functions : forced vital capacity and forced expiratory volume in one second done by spirometer
Timepoint [1] 291284 0
immediate postoperative lung functions , after 12 hours and after 24 hours
Secondary outcome [1] 306421 0
postoperative pulmonary complications such as atelectasis, pulmonary oedema, pneumonia pleural effusion , hypercapnia, acute lung injury, pulmonary embolism, prolonged respiratory failure. these complications are diagnosed clinically ,and radiologically
Timepoint [1] 306421 0
within 3 days of the operation

Eligibility
Key inclusion criteria
adult patients ASA II undergoing urosurgical procedurs lasting at least 2 hours receiving general anaesthesia in the lateral position
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients with respiratory 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)
eligible patients are randomly allocated to one of the two study groups by a physician to whom concealment was done by closed envelops
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
sequence generation will be done with randome table
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
sample size calculation : 50 patients are needed .Based on previously published data using "the surveysystems website"assuming 15% difference in fvc and fev1 as a confidence interval at 95% confidence level. comparison of normally distributed variables will be performed with paired or unpaired t test as appropriate and Mann-Whitney and wilcoxon tests will be used for other variables

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/02/2014
Actual
Date of last participant enrolment
Anticipated
1/09/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 5753 0
Egypt
State/province [1] 5753 0

Funding & Sponsors
Funding source category [1] 288568 0
University
Name [1] 288568 0
south valley university
Country [1] 288568 0
Egypt
Funding source category [2] 288569 0
Hospital
Name [2] 288569 0
qena university hospital
Country [2] 288569 0
Egypt
Primary sponsor type
University
Name
south valley university
Address
qena p.o. 83523
Country
Egypt
Secondary sponsor category [1] 287280 0
Hospital
Name [1] 287280 0
qena university hospital
Address [1] 287280 0
qena - P.O. 83523
Country [1] 287280 0
Egypt

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290429 0
ethics committee of qena faculty of medicine
Ethics committee address [1] 290429 0
qena faculty of medicine -Qena - P.O. 83523- Qena -Egypt
Ethics committee country [1] 290429 0
Egypt
Date submitted for ethics approval [1] 290429 0
18/01/2014
Approval date [1] 290429 0
Ethics approval number [1] 290429 0

Summary
Brief summary
we intend to study the effect of low tidal volume during general anaesthesia as a lung protective method on the postoperative lung functions and postoperative pulmonary complications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45662 0
A/Prof salah mostafa asida
Address 45662 0
anesthesia department- qena university hospital- Qena - P.O. 83523 Qena
Country 45662 0
Egypt
Phone 45662 0
+2 0100 5262075
Fax 45662 0
Email 45662 0
[email protected]
Contact person for public queries
Name 45663 0
A/Prof salah mostafa asida
Address 45663 0
qena university hospital - Qena P.O. 83523 Qena
Country 45663 0
Egypt
Phone 45663 0
+2 01005262075
Fax 45663 0
Email 45663 0
[email protected]
Contact person for scientific queries
Name 45664 0
A/Prof salah mostafa asida
Address 45664 0
qena university hospital- Qena P.O. 83523. Qena
Country 45664 0
Egypt
Phone 45664 0
+2 0100 5262075
Fax 45664 0
Email 45664 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 low tidal volume during general anesthesia for urological procedures on lung fun ctions.2015https://dx.doi.org/10.1016/j.egja.2015.02.001
N.B. These documents automatically identified may not have been verified by the study sponsor.