Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000994684
Ethics application status
Approved
Date submitted
2/09/2014
Date registered
16/09/2014
Date last updated
16/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Ease of laryngeal mask airway insertion in children undergoing surgery
Scientific title
ease of the insertion of laryngeal mask airway in pediatric surgical patients : predictors of failure and outcome
Secondary ID [1] 285282 0
nil
Universal Trial Number (UTN)
U1111-1161-1129
Trial acronym
none
Linked study record

Health condition
Health condition(s) or problem(s) studied:
laryngeal mask airway (LMA) insertion in paediatric surgical patients 292945 0
Condition category
Condition code
Anaesthesiology 293241 293241 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
the ease of LMA insertion from the first attempt in children at induction of general anesthesia together with any problems that would accompany the procedure during operative time and immediate post-operative will be recorded
Intervention code [1] 290175 0
Not applicable
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293092 0
success of LMA insertion from the first attempt in children assessed by the free respiration transmitted to the anesthesia circuit bag and normal Spo2
Timepoint [1] 293092 0
immediately after induction of anesthesia
Secondary outcome [1] 310319 0
incidence of complications associated with the LMA insertion such as bucking ,gaging, vomiting desaturation, respiratory obstruction
Timepoint [1] 310319 0
after induction of anesthesia and immediately postoperatively

Eligibility
Key inclusion criteria
pediatric surgical patients admitted for any short term surgery
Minimum age
6 Months
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
abnrmality of the airway , any sure indication for endotracheal tube placement

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
data well be collected using a standardized collection sheet and analyzed using microsoft excel sheet and PASW statistics 18 (SPSS Inc.,Chicago,IL, USA)
Sample size estimation was performed to define the limits
of data analysis. Based on LMA failure rates as great as
5%, a sample size of 5,00 patients would allow evaluation of at least 12 covariates in a logistic regression model with minimal risk of over-fitting.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/10/2014
Actual
Date of last participant enrolment
Anticipated
15/04/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment outside Australia
Country [1] 6333 0
Egypt
State/province [1] 6333 0
qena

Funding & Sponsors
Funding source category [1] 289901 0
University
Name [1] 289901 0
south valley university
Country [1] 289901 0
Egypt
Primary sponsor type
University
Name
south valley university
Address
south valley university -Qena -p.o. 83523 egypt
Country
Egypt
Secondary sponsor category [1] 288590 0
Hospital
Name [1] 288590 0
Qena university hospital
Address [1] 288590 0
Qena P.O. 83523
Country [1] 288590 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291623 0
ethics comm. of Qena faculty of medicine
Ethics committee address [1] 291623 0
Ethics committee country [1] 291623 0
Egypt
Date submitted for ethics approval [1] 291623 0
Approval date [1] 291623 0
20/08/2014
Ethics approval number [1] 291623 0

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

Contacts
Principal investigator
Name 51202 0
A/Prof salah asida
Address 51202 0
Qena university hospital p.o. 83523 Qena
Country 51202 0
Egypt
Phone 51202 0
+2 0100 5262075
Fax 51202 0
Email 51202 0
[email protected]
Contact person for public queries
Name 51203 0
salah asida
Address 51203 0
Qena university hospital p.o. 83523 Qena
Country 51203 0
Egypt
Phone 51203 0
+2 0100 52 62 075
Fax 51203 0
Email 51203 0
[email protected]
Contact person for scientific queries
Name 51204 0
salah asida
Address 51204 0
Qena university hospital p.o. 83523 Qena
Country 51204 0
Egypt
Phone 51204 0
+2 0100 52 62 075
Fax 51204 0
Email 51204 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
EmbaseEase of insertion of the laryngeal mask airway in pediatric surgical patients: Predictors of failure and outcome.2016https://dx.doi.org/10.4103/1658-354X.174898
N.B. These documents automatically identified may not have been verified by the study sponsor.