Clinical trial NCT03931122: Comparison of Weight-based Versus External Ear-size Based Technique for Selection of Laryngeal Mask Airway in Pediatric Surgical Patients.
Official title: Comparison of Weight-based Versus External Ear-size Based Technique for Selection of Laryngeal Mask Airway in Pediatric Surgical Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngeal Masks
Minors
Child
Pediatrics
Keywords: Ear Size
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 136
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All Laryngeal Mask Airways (LMA) devices being used in the study will be Ambu® AuraOnce™ (Ambu® A/S Baltorpbakken 13 DK-2750 Ballerup, Denmark) LMA's.

LMA Size Selection: will be done for each patient according to group allocation:

Group A - Weight based method Group B - Ear Size Based method

Randomization technique:

Patients will be randomized according to computer-generated blocked randomization (https://www.sealedenvelope.com) with blocks size of 6, by independent statistician (Anaesthesia research cell). Allocation concealment will be ensured by enclosing assignments in sealed, opaque, sequentially numbered envelopes which will be opened by one of the investigator only upon arrival of the patient in the operation room.
Primary purpose: PREVENTION

Brief summary: Laryngeal Mask Airway (LMA) is widely used in pediatric surgical patients. The manufacturer recommends the size of LMA to be used in children should be based on actual body weight but this method has several limitations. To overcome these concerns, various alternatives have been tried by different researchers, one of them is external ear size for LMA size selection. Investigators therefore would like to know whether the external ear size based method can be used for LMA size selection in pediatric surgical patients in Pakistan.

Detailed description: OBJECTIVE:

to determine whether external ear-size is non-inferior to weight for LMA size selection in pediatric surgical patients.

INTRODUCTION:

The Laryngeal Mask Airway (LMA) is widely used in pediatric population. The manufacturer recommends the size of LMA to be used in children should be based on actual body weight. However, this method has several limitations, the range of weight for a particular size is very wide, it may not be appropriate for overweight or underweight children as it is based on actual body weight rather than ideal body weight, in emergency situations where weight of the patient is unknown the correlation between weight and size of LMA is impossible, and finally weight based recommendation may not be suitable as development of the child's oropharyngeal cavity is related to height and age rather than weight. All these factors may lead to inappropriate size selection, which may result in larger sized LMA causing trauma/injury to the airway and smaller ones causing obstruction or insufficient ventilation. To overcome these concerns various alternatives to weight based technique have been tried by different researchers in both adult and pediatric patients, one of them is external ear size. Literature revealed differences in external ear size dimensions in different ethnic population and the investigator's literature search failed to reveal any local data/study in Pakistani pediatric patients where external ear size was compared or used for size selection of the LMA. The investigators therefore would like to know whether the external ear size based method can be used for LMA size selection in pediatric surgical patients in Pakistan.

HYPOTHESIS:

External ear-size based technique is not inferior to weight based technique for LMA selection in pediatric population.

Eligibility criteria: Inclusion Criteria:

1. All children aged between 6 months to 18 years of age of either sex
2. American Society of Anesthesiologist (ASA) Classification I-II
3. Elective surgical procedures in whom an LMA will be indicated
4. Procedure lasting up to 2hrs

Exclusion Criteria:

1. Any external ear morphological abnormality
2. Previous external ear surgeries
3. Patient/Parent refusal
4. Children with oropharyngeal lesion
5. Any patient conditions (Gastroesophageal Re-flux Disease \[GERD\], hiatal hernia, incomplete NPO, bowel obstruction etc.) or procedures requiring rapid sequence induction and intubation
6. History of Upper respiratory tract infection (URTI) within the last 2 weeks

Primary outcomes:
measure: Proper Placement
timeFrame: 1 minute
measure: Adequacy of Ventilation
timeFrame: 1 minute
Secondary outcomes:
measure: Oropharyngeal Leak Pressure (OLP)
timeFrame: 30 seconds
measure: Leak fraction (LF)
timeFrame: 1 minute
measure: Incidence of mucosal injury and laryngospasm
timeFrame: 1 minute
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Muhammad Asghar Ali
state: Sindh
Study officials:
affiliation: The Aga Khan University Hospital, Karachi, Pakistan.
name: Muhammad Qamarul Hoda, FCAI
role: PRINCIPAL_INVESTIGATOR
affiliation: The Aga Khan University Hospital, Karachi, Pakistan.
name: Muhammad Asghar Ali, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: The Aga Khan University Hospital, Karachi, Pakistan.
name: Hameed Ullah, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: The Aga Khan University Hospital, Karachi, Pakistan.
name: Samie Asghar Dogar, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: The Aga Khan University Hospital, Karachi, Pakistan.
name: Muhammad Saad Yousuf, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: The Aga Khan University Hospital, Karachi, Pakistan.
name: Bushra Salim, FCPS
role: PRINCIPAL_INVESTIGATOR
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