Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000066684
Ethics application status
Approved
Date submitted
17/12/2013
Date registered
21/01/2014
Date last updated
21/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Association between Thenar Eminence and I-gel Dimensions in Paediatric Patients
Scientific title
The Association between Thenar Eminence and I-gel Dimensions Regarding Width and Length for Paediatric Patients Scheduled for Elective Surgery
Secondary ID [1] 283787 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Describe an anatomic landmark to find the appropriate size of the I-gel for use in paediatric patients 290765 0
Condition category
Condition code
Anaesthesiology 291128 291128 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
The duration of the procedure
Target follow-up type
Description of intervention(s) / exposure
After obtaining local research ethical committee approval, two hundred and seventy ASA Class I or II patients between 0 to 12 years old, who were scheduled for elective surgery under general anaesthesia not requiring tracheal intubation were recruited to the study. Written informed consent was taken from the parents. Children with risk factors for difficult airway or regurgitation and syndrome or disorders influencing bone or soft tissue growth were excluded. Patients in the operating room were monitored for standard electrocardiography (ECG), blood pressure non invasively and peripheral oxygen saturation (SpO2). After preoxygenation, anaesthesia induction was performed with 8% sevoflurane in 50% nitrous oxide and oxygen, followed by intravenous access and administration of fentanyl 1 micro.kg-1. No muscle relaxants were used. Adequate anaesthetic depth was confirmed by lack of a motor response to jaw thrust. The i-gel is a novel supraglottic airway management device, made of a medical grade thermoplastic elastomer, which is soft, gel-like and transparent. Its non-inflatable cuff fits snugly onto the perilaryngeal framework. The size of the I-gel selected was based on the patient’s body weight according to the manufacturer recommendation . (size 1: 2-5 kg, size 1.5: 5-12 kg, size 2: 10-25 kg, size 2.5: 25-35 kg). Size 1.5 i-gel was inserted in children weighing 10-12 kg, and if there was an audible leak it was decided to change the size 1.5 to size 2. The device was inserted with “sniffing the morning air” position, and depending upon the airway manipulations (like neck flexion, head extension, jaw thrust, or deep rotation) required to insert the device. Correct insertion was judged by symmetric chest expansion, square wave of the capnograph trace, and absence of audible leak. The number of insertion attempts was noted, and it was considered a failure if the insertion was not successful in three attempts. In this case, patient was intubated, and excluded from the study. After successful insertion of the I-gel, thenar eminence dimensions were determined from left hand while fingers were placed in neutral position. Measurements were performed with a ruler in approximately 15 seconds. Long axis (Th-l) was measured from joining point of thumb to hand crease and short axis (Th-w) constitutes the largest portion of the thenar eminence from lateral end of the thumb to the first vital crease. Width (Ig-w) and length (Ig-l) of the I-gel’s (size 1-1.5-2-2.5) soft non-inflatable cuff was measured. The manufacturer's dimensions of the I-gel which was inserted into the patients were compared with the measurements obtained from thenar eminence.
Intervention code [1] 288473 0
Not applicable
Comparator / control treatment
There was no control treatment.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291114 0
To investigate the association between thenar eminence and i-gel dimensions regarding for width and length in paediatric patients.
Timepoint [1] 291114 0
Thenar eminence and I-gel dimensions were measured immediately after I-gel was successfully inserted into the participant.
Secondary outcome [1] 306016 0
The secondary outcome was the number of the patients which the i-gel was placed successfully at the first attempt. Correct insertion was judged by symmetric chest expansion, square wave of the capnograph trace, and absence of audible leak. This outcome was assessed and documented by the anaesthesiologist.
Timepoint [1] 306016 0
Immediately after correct insertion was confirmed by the anaesthesiologist the number of insertion attempts was noted.

Eligibility
Key inclusion criteria
ASA Class I or II patients between 0 to 12 years old, who were scheduled for elective surgery under general anaesthesia not requiring tracheal intubation
Minimum age
3 Days
Maximum age
144 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with risk factors for difficult airway or regurgitation and syndrome or disorders influencing bone or soft tissue growth were excluded.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A total sample size of 258 was required to detect at least 0.20 correlations between thenar eminence and i-gel’s cuff measurements with a power of 90% at the 5% significance level. Sample size estimation was performed by using NCSS and PASS 2000 (Hintze J. 2001. NCSS and PASS. Number Cruncher Statistical Systems. Kaysville, Utah.) software. This study was designed to enroll 270 patients to allow for potential dropout of subjects.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2013
Actual
1/05/2013
Date of last participant enrolment
Anticipated
Actual
27/09/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
258
Accrual to date
Final
Recruitment outside Australia
Country [1] 5686 0
Turkey
State/province [1] 5686 0

Funding & Sponsors
Funding source category [1] 288446 0
Self funded/Unfunded
Name [1] 288446 0
Country [1] 288446 0
Primary sponsor type
Individual
Name
Ozgun CUVAS APAN
Address
Giresun University Medical Faculty, Department of Anaesthesiology and Intensive Care Medicine, Nizamiye Yerleskesi, Orhan Yilmaz Cad. Mumcular Sokak No:1 Postal Code: 28200, Merkez, Giresun.
Country
Turkey
Secondary sponsor category [1] 287149 0
None
Name [1] 287149 0
Address [1] 287149 0
Country [1] 287149 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290320 0
Kirikkale University Ethics Committee
Ethics committee address [1] 290320 0
Ethics committee country [1] 290320 0
Turkey
Date submitted for ethics approval [1] 290320 0
Approval date [1] 290320 0
15/04/2013
Ethics approval number [1] 290320 0

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

Contacts
Principal investigator
Name 45066 0
A/Prof Ozgun CUVAS APAN
Address 45066 0
Giresun University Medical Faculty, Department of Anaesthesiology and Intensive Care Medicine, Nizamiye Yerleskesi, Orhan Yilmaz Cad. Mumcular Sokak No:1 Postal Code: 28200, Merkez, Giresun.
Country 45066 0
Turkey
Phone 45066 0
+90454 310 16 00
Fax 45066 0
Email 45066 0
[email protected]
Contact person for public queries
Name 45067 0
Ozgun CUVAS APAN
Address 45067 0
Giresun University Medical Faculty, Department of Anaesthesiology and Intensive Care Medicine, Nizamiye Yerleskesi, Orhan Yilmaz Cad. Mumcular Sokak No:1 Postal Code: 28200, Merkez, Giresun.
Country 45067 0
Turkey
Phone 45067 0
+90454 310 16 00
Fax 45067 0
Email 45067 0
[email protected]
Contact person for scientific queries
Name 45068 0
Ozgun CUVAS APAN
Address 45068 0
Giresun University Medical Faculty, Department of Anaesthesiology and Intensive Care Medicine, Nizamiye Yerleskesi, Orhan Yilmaz Cad. Mumcular Sokak No:1 Postal Code: 28200, Merkez, Giresun.
Country 45068 0
Turkey
Phone 45068 0
+90454 310 16 00
Fax 45068 0
Email 45068 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.