NCT03845998

Compare the Efficacy of Different Laryngeal Mask Size Selection Methods in General Anesthesia in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 392 (actual)
• Sponsor: Eye & ENT Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 3 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

The laryngeal mask is widely used in general anesthesia in children. Selection of an appropriately sized laryngeal mask airway (LMA) is critical to ensure safe and effective use of the device. In children, the appropriate size of the LMA to be used is usually determined by the patient's weight. Up to now, this is the gold standard method, but the weight-related technique is not always possible. The patient's weight is sometimes unknown or medical staff do not remember the relationship between weight and size. Moreover, there are no constant correlations between laryngeal airways and body indices such as height and weight, so that the standard method could cause an inappropriate size of laryngeal mask airway to be chosen. Researchers from Spain introduced a new technique to determine the size of the LMA in children by choosing the LMA that best matched the combined widths of the patient's index, middle and ring fingers, but needs to be formally evaluated in clinical application. In order to compare the application effects of two methods (weight-related and three-fingers), we designed a research plan.

Detailed description

The allocation sequence is generated by computer random number generation, and the allocation is placed in sequentially numbered opaque sealed envelopes by a non-investigator. Enrolment and data collection are performed by trained research staff who are not involved in the care of the patients. The treating clinicians are not blinded to the assignment group, but all other staff involved in both the collection and collation of data are blinded to group allocation. The primary measurement is the oropharyngeal leak pressure (OLP) at the recommended intracuff pressure. The secondary measurements included insertion time, fibreoptic view grade, insufficient ventilation, and the occurrence of complications such as postoperative sore throat. The sample size was calculated to be 390 by a statistical software based on previous research results. The continuous variables were expressed as means ± standard deviation (SD) whereas categorical variables were expressed as frequency and percentage for data description. P \<0.05 was considered statistically significant.

Conditions

• Airway Management

Interventions

Type	Name	Description
PROCEDURE	use the three-finger method	The size of the laryngeal mask airway was determined by choosing the laryngeal mask that best matched the combined widths of the patient's index, middle and ring fingers.
PROCEDURE	use the weight-related method	The size of the laryngeal mask airway was determined by the patient's weight.

Timeline

• Start date: 2019-02-25
• Primary completion: 2019-05-01
• Completion: 2019-05-25
• First posted: 2019-02-19
• Last updated: 2020-02-17

Locations

1 site across 1 country: China