Comparison of Weight-based Versus External Ear-size Based Technique for Selection of Laryngeal Mask Airway in Pediatric Surgical Patients.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Child
- Laryngeal Masks
- Minors
- Pediatrics
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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.Masking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: 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.Primary Purpose: Prevention
Participation Requirements
- Age
- Younger than 618 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT03931122
- Collaborators
- Not Provided
- Investigators
- 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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