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

Child Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03931122
• Other study ID #: 2019-0246-3299
• Status: Recruiting
• Phase: N/A
• Start date: December 11, 2019
• Est. completion date: July 30, 2024

Study information

• Verified date: January 2023
• Source: Aga Khan University
• Contact: Dr. Muhammad Qamarul Hoda, FCAI
• Phone: 0092-21-3486-4631
• Email: qamar.hoda[@]aku.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: July 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Child
• Laryngeal Masks
• Minors
• Pediatrics

Intervention

Device:
• Ear Size Based Method (Ambu® AuraOnce™ Laryngeal Mask Airway)
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.

Locations

Country	Name	City	State
Pakistan	Dr. Muhammad Qamarul Hoda	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proper Placement	Proper LMA placement will be assessed by chest expansion on positive pressure ventilation, absence of audible leak and a square wave capnograph waveform.	1 minute
Primary	Adequacy of Ventilation	Adequacy of ventilation: will be judged by an oxygen saturation of greater than or equal to 95% at a Fractional Inspired Oxygen concentration (FiO2) less than 0.5 and an end-tidal carbon dioxide (ETCO2) of 35-45 mmHg at a tidal volume of 6- 8 ml/kg Actual Body Weight (ABW) at peak airway pressure less than the oropharyngeal leak pressure (OLP), and by adjusting the respiratory rate (RR).	1 minute
Secondary	Oropharyngeal Leak Pressure (OLP)	Oropharyngeal Leak Pressure (OLP): will be determined at LMA intra-cuff pressure of 60 cmH2O by closing the Adjustable Pressure Limiting (APL) valve of the circle system at a fixed gas flow of 3 Liters per minute and by noting the circuit pressure at which an equilibrium will be reached and then releasing it completely.	30 seconds
Secondary	Leak fraction (LF)	Leak fraction (LF): will be determined by comparing the difference between inspired and expired tidal volumes and dividing them by the inspired tidal volume at a tidal volume (TV) of 8 ml/kg actual body weight (ABW) with an I:E ratio of 1:2 and respiratory rate (RR) of 20 breaths per minute.	1 minute
Secondary	Incidence of mucosal injury and laryngospasm	Incidence of mucosal injury in the two groups will be assessed by trauma or minor injury to the airway seen as blood on the device after removal.; Incidence of laryngospasm will also be noted.	1 minute