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Comparison of Weight-based Versus External Ear-size Based Technique for Selection of Laryngeal Mask Airway in Pediatric Surgical Patients.

Last Updated: 2024-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-11

Study Completion Date

2024-06-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Laryngeal Masks Minors Child Pediatrics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

One of the investigators will record patients' weight and external ear measurements in the study proforma. Patient's medical record (MR) number will then be send to the Research assistant/ Statistician for randomization into one of the groups (Group A or Group B). On the day of surgery, research assistant will hand over patient's group allocation in a sealed opaque envelop to one of the investigators who will not be the primary anesthetist. This investigator will determine the LMA size according to the group allocation. In case the dimensions fall between the two sizes of LMA in the ear size group, the closest one will be selected. After writing LMA size in the proforma it will be handed over to the primary anesthetist who will be blinded to patient's group allocation. Primary anesthetist (who has an experience of minimum 50 LMA insertions) will use the LMA.

Study Groups

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Group A - Weight Based Method

Body Weight Based method: This is the conventional method for LMA size selection. The patient will be weighed and LMA size corresponding to their weight will be used as follows.

(LMA Size - 1 for up to 5 kg of body weight) (LMA Size - 1.5 for 5 to 10 kg of body weight) (LMA Size - 2 for 10 to 20 kg of body weight) (LMA Size - 2.5 for 20 to 30 kg of body weight) (LMA Size - 3 for 30 to 50 kg of body weight)

Group Type NO_INTERVENTION

No interventions assigned to this group

Group B - Ear Size Based Method

Ear Size Based method: External ear size will be measured by using a paper ruler and will be recorded in cm as follows:

Vertical length: will be measured from the most dependent portion of the lobule to the furthest portion of the auricle.

Horizontal length (width): from the tragus to the furthest part of the helix horizontally.

Dimension(cm2): Vertical length (L) × Horizontal length (width-W )

Based on these ear measurements, nearest smaller LMA size will be selected.

Group Type EXPERIMENTAL

Ear Size Based Method (Ambu® AuraOnce™ Laryngeal Mask Airway)

Intervention Type DEVICE

The Laryngeal Mask Airway (LMA) is one of the devices used to maintain airway during general anesthesia. Its appropriate size is selected according to patients body weight as recommended by the manufacturer.

However its appropriate size can also be selected via several other methods and one of them is patients external ear size. In this study the investigators will compare external ear size based method for LMA selection with the standard weight based method for LMA size selection.

Vertical Ear length: will be measured from the most dependent portion of the lobule to the furthest portion of the auricle.

Horizontal Ear length (width): from the tragus to the furthest part of the helix horizontally.

Dimension(cm2): Vertical length (L) × Horizontal length (width-W)

LMA Size LMA Cuff Length (cm) corresponding to vertical ear length.

LMA Cuff Width (cm) corresponding to horizontal ear width.

Interventions

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Ear Size Based Method (Ambu® AuraOnce™ Laryngeal Mask Airway)

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Muhammad Qamarul Hoda

Professor, Department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR