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Clinicaltrials.gov identifier NCT03931122
Recruitment Status Recruiting
First Posted April 30, 2019
Last update posted January 2, 2020
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.
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.
|Experimental: 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.
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.
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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
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
Contact: Dr. Muhammad Qamarul Hoda, FCAI 0092-21-3486-4631 ext 4631 firstname.lastname@example.org
Contact: Dr. Hameed Ullah, FCPS 0092-21-3486-2898 ext 2898 email@example.com
Dr. Muhammad Qamarul Hoda
Aga Khan University
Principal Investigator: Dr. Muhammad Qamarul Hoda, FCAI The Aga Khan University Hospital, Karachi, Pakistan.
Principal Investigator: Dr. Ali Asghar, FCPS The Aga Khan University Hospital, Karachi, Pakistan.
Principal Investigator: Dr. Hameed Ullah, FCPS The Aga Khan University Hospital, Karachi, Pakistan.
Principal Investigator: Dr. Samie Asghar Dogar, FCPS The Aga Khan University Hospital, Karachi, Pakistan.
Principal Investigator: Dr. Muhammad Saad Yousuf, FCPS The Aga Khan University Hospital, Karachi, Pakistan.
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