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Trial registered on ANZCTR


Registration number
ACTRN12614000477628
Ethics application status
Approved
Date submitted
2/05/2014
Date registered
8/05/2014
Date last updated
8/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Laryngeal Mask Airway (LMA) versus Endotracheal Tube (ETT) on incidence, of perioperative adverse respiratory events, in obese children with recent cold undergoing upper airways surgery.
Scientific title
the effect of insertion of LMA and ETT in intubating obese children with recent cold on adverse respiratory events(complications).
Secondary ID [1] 284527 0
nill
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthesiology for obese pediatric patients with recent cold in upper airway surgeries. 291783 0
Condition category
Condition code
Anaesthesiology 292149 292149 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
(Group I) : LMA group, 32 obese children with recent cold use LMA for intubation in upper airway surgeries.

(Group II): ETT group, 32 obese children with recent cold use ETT for intubation in upper airway surgeries.

Intervention code [1] 289289 0
Treatment: Devices
Comparator / control treatment
use of ETT for intubation of obese children with recent cold in upper airway surgeries.

active control.

Control group
Active

Outcomes
Primary outcome [1] 292027 0
compare between LMA and ETT effects on incidence of adverse perioperatively respiratory events, in obese children with uncomplicated recent cold (primary outcome) e.g breath holding, coughing, laryngospasm, bronchospasm, and oxygen desaturation.
Timepoint [1] 292027 0
on each stage of anesthesia:
at Induction, Insertion of LMA or ETT, Maintenance, Emergence of anesthesia and Postoperative period (until discharge from the post anesthesia care unit)
Secondary outcome [1] 308024 0
early detection and management of complications e.g. aspiration, postoperative nausea and vomiting, bleeding, dysrhythmia (secondary outcome).
Timepoint [1] 308024 0
during operations and postoperative period until discharge from hospitals.

Eligibility
Key inclusion criteria
children age 2-8 years with recent uncomplicated cold (without symptomatic wheezing, purulent secretion and fever),

ASA I and II

BMI > 95% of child age and sex. Weight and height were used to measure BMI (weight/height2)
Minimum age
2 Years
Maximum age
8 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
children BMI <95% of child age and sex,

symptoms of fever, purulent secretion and wheeze was any of them present,

ASA physical status >II

refusal of parents.

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)
sealed opaque envelops
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
patients were randomized into two equal groups of patients via a table of random numbers using a computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Due to the procedures are impossible to be blind to the type of tube being used, all observations are recorded by qualified anesthetists who are not enrolled in the study.
Phase
Type of endpoint(s)
Statistical methods / analysis
Data are presented as mean +/- (SD) for normally distributed data. Baseline characteristics and outcomes across the groups were compared using the Student's t-test for continuous variables and chi-square analysis for nominal data. All analysis has been calculated using SPSS V.16. A P-value of <0.05 was considered to indicate statistical significance.

In deciding sample size we assumed that respiratory complications in obese children with recent cold will be greater than asymptomatic obese children at least by fivefold, if we assumed that complication in asymptomatic obese children will be 5% so we expected incidence of 25% complications in obese children with recent cold, from previous frequencies, based on a previous study on obese children without cold in our hospital a sample size of 29 children in each group will be convenient(a = 0.05 and a power of 0.8 with 95% confidence interval).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6027 0
Egypt
State/province [1] 6027 0
Tanta / Gharbia

Funding & Sponsors
Funding source category [1] 289162 0
Self funded/Unfunded
Name [1] 289162 0
Rehab S. EL Kalla
Address [1] 289162 0
Department of Anesthesia and surgical Intensive care, Faculty of Medicine, Tanta University.
EL Geish st.
Tanta / Gharbia
31257
Egypt.
Country [1] 289162 0
Egypt
Primary sponsor type
Individual
Name
Rehab S. EL Kalla
Address
Department of Anesthesia and surgical Intensive care, Faculty of Medicine, Tanta University.
EL Geish st.
Tanta / Gharbia
31257
Egypt.
Country
Egypt
Secondary sponsor category [1] 287827 0
Individual
Name [1] 287827 0
Mohamad G. Ayaad
Address [1] 287827 0
Department of Anesthesia and surgical Intensive care, Faculty of Medicine, Tanta University.
EL Geish st.
Tanta / Gharbia
31257
Egypt.
Country [1] 287827 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290934 0
Institutional Ethics Committee of the Faculty of Medicine, Tanta University
Ethics committee address [1] 290934 0
Faculty of Medicine, Tanta University.
EL Geish st.
Tanta / Gharbia
31257
Egypt.
Ethics committee country [1] 290934 0
Egypt
Date submitted for ethics approval [1] 290934 0
Approval date [1] 290934 0
25/08/2012
Ethics approval number [1] 290934 0

Summary
Brief summary
Overweight and obesity in children become a wide problem facing anesthetists' every day. Furthermore, cold is a viral origin infection that commonly occurs in children, there is always debate for years whether to proceed in anesthetizing with general anesthesia or not for children with recent cold because risk of increase incidence of perioperative respiratory adverse events.

this is a prospective randomly unblinded study in 64 obese children (BMI>95% of child age and sex) with recent cold aged 2- 8 years undergoing elective upper airways surgery to compare the incidence of perioperative respiratory adverse events in manipulation of airways either by LMA or ETT (primary outcome), early detection and optimizing the anesthetic management of complications may occur (secondary outcome).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48050 0
Dr Rehab S. EL Kalla
Address 48050 0
Lecturer of Anesthesiology and surgical Intensive care Department of Anesthesia and surgical Intensive care, Faculty of Medicine, Tanta University
EL Geish st.
Tanta / Gharbia
31257
Egypt.


Country 48050 0
Egypt
Phone 48050 0
+201285700765
Fax 48050 0
Email 48050 0
rehouba10@hotmail.com
Contact person for public queries
Name 48051 0
Dr Mohamad G. Ayaad
Address 48051 0
Lecturer of Anesthesiology and surgical Intensive care Department of Anesthesia and surgical Intensive care, Faculty of Medicine, Tanta University
EL Geish st.
Tanta / Gharbia
31257
Egypt.
Country 48051 0
Egypt
Phone 48051 0
+201128396916
Fax 48051 0
Email 48051 0
drmohamadayaad@gmail.com
Contact person for scientific queries
Name 48052 0
Prof Abd EL Rahim Dowidar
Address 48052 0
professor of Anesthesiology and surgical Intensive care Department of Anesthesia and surgical Intensive care, Faculty of Medicine, Tanta University
EL Geish st.
Tanta / Gharbia
31257
Egypt.
Country 48052 0
Egypt
Phone 48052 0
+201223195015
Fax 48052 0
Email 48052 0
dr.dowidar47@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary