Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000835549
Ethics application status
Approved
Date submitted
28/05/2015
Date registered
11/08/2015
Date last updated
11/08/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Radial versus Dorsalis pedis artery for Invasive Blood Pressure monitoring in Pediatric laparoscopic abdominal surgery
Scientific title
a comparison between Radial artery and Dorsalis pedis artery for Invasive Blood Pressure monitoring in Pediatric laparoscopic abdominal surgery as regards the difference in blood pressure values and complications
Secondary ID [1] 286825 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
blood pressure monitoring during pediatric laparoscopic abdominal surgery 295205 0
Condition category
Condition code
Anaesthesiology 295455 295455 0 0
Other anaesthesiology
Surgery 295760 295760 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
a 35 pediatric patients who were scheduled to have a laparoscopic abdominal surgery, received cannulation of both radial artery and dorsalis pedis artery for invasive blood pressure monitoring from induction of anaesthesia until completion of surgery.
Intervention code [1] 291984 0
Treatment: Devices
Intervention code [2] 292370 0
Diagnosis / Prognosis
Intervention code [3] 292371 0
Early detection / Screening
Comparator / control treatment
Radial artery cannulation and blood pressure measurement
Control group
Active

Outcomes
Primary outcome [1] 295184 0
difference between radial artery and dorsalis pedis artery for measurement of invasive blood pressure
Timepoint [1] 295184 0
point 1 (before abdominal inflation):
point 2 (immediately after abdominal inflation)
point 3 (10 minutes after abdominal inflation)
point 4 (20 minutes after abdominal inflation)
point 5 (30 minutes after abdominal inflation)
point 6 (after abdominal deflation)
Secondary outcome [1] 314976 0
effect of abdominal inflation on invasive blood pressure by measuring blood pressure by direct invasive pressure monitor
Timepoint [1] 314976 0
point 1 (before abdominal inflation):
point 2 (immediately after abdominal inflation)
point 3 (10 minutes after abdominal inflation)
point 4 (20 minutes after abdominal inflation)
point 5 (30 minutes after abdominal inflation)
point 6 (after abdominal deflation)

Eligibility
Key inclusion criteria
- ASA physical status I-II
- age:1- 6 years
- scheduled for laparoscopic abdominal surgery
- had general anesthesia
Minimum age
1 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- conversion to open surgery
- age less than 1 year or more than 6 years
- contraindication to arterial cannulation e.g. site infection

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised 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
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Data of age, weight and height were analyzed as Mean+/-SD. Sex of patients and types of operations were presented as number and percentage. Blood pressures in both radial artery and dorsalis pedis artery were compared by Paired T test. Pearson and concordance correlation were used to analyze the relation between blood pressure in radial artery and blood
pressure in dorsalis pedis artery.
One way repeated measures anova with Bonferroni’s correction was used for serial blood pressure measurements. Multivariate anova with repeated measures and covariates was used for interactions by other risk factors.
Sample Size estimated as follow: Assuming a error = 0.05 (two-tailed) and Beta error = 0.1, a sample size of 32 patients was targeted but the actual sample size was 35 patients, allocated into one group, will have a power of 90% to detect an assumed clinically significant difference of 5% (effect size d = 0.6) or more between the blood pressure measurements at radial and dorsalis pedis arteries. t test for matched pairs was used to estimate the sample size.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2014
Actual
1/12/2014
Date of last participant enrolment
Anticipated
30/04/2015
Actual
30/04/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
35
Recruitment outside Australia
Country [1] 6908 0
Egypt
State/province [1] 6908 0
Beni Suef

Funding & Sponsors
Funding source category [1] 291371 0
Hospital
Name [1] 291371 0
Beni Suef University hospital
Country [1] 291371 0
Egypt
Primary sponsor type
Hospital
Name
Beni Suef University hospital
Address
Egypt, Beni Suef city, Mokbl street, P.O. 62511
Country
Egypt
Secondary sponsor category [1] 290050 0
None
Name [1] 290050 0
Address [1] 290050 0
Country [1] 290050 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57670 0
Dr Ahmed Abdelaal Ahmed Mahmoud
Address 57670 0
work address:
Beni Suef University Hospital, hassan mohamed street, Alshamla district, Beni Suef city, Beni Suef Governorate, Egypt. P.O. 62511.
Country 57670 0
Egypt
Phone 57670 0
+201113308866
Fax 57670 0
Email 57670 0
[email protected]
Contact person for public queries
Name 57671 0
mohamed mohamed abdelhaq
Address 57671 0
department of anesthesia, faculty of medicine, cairo university,Almanial street, Cairo, Egypt. P.O. 11965
Country 57671 0
Egypt
Phone 57671 0
+201000053764
Fax 57671 0
Email 57671 0
[email protected]
Contact person for scientific queries
Name 57672 0
Ahmed Mostafa Alsharawy
Address 57672 0
department of anesthesia, faculty of medicine, beni suef university,mokbl street, beni suef, Egypt. P.O. 62511
Country 57672 0
Egypt
Phone 57672 0
+201141015584
Fax 57672 0
Email 57672 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
No additional documents have been identified.