Skip to main content
OpenTrials
Completed

NCT Number: NCT03845998

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Airway Management

Age range

3 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jie Jia

Shanghai, 021, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • children aged from 3 to 14yr, underwent elective ophthalmic surgery, had an American Society of Anesthesiologists physical status rating of I or II

Exclusion criteria

  • Patients with lung disease, known airway problems, upper respiratory tract symptoms or any condition that may increase the risk of gastro-oesophageal regurgitation, or any anatomical abnormalities, especially those related to the head, neck or limbs.

Treatment and study plan

use the three-finger method

Procedure

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.

use the weight-related method

Procedure

The size of the laryngeal mask airway was determined by the patient's weight.

Primary outcomes

  1. oropharyngeal leak pressure (OLP)

    Time frame: The OLP was measured after the laryngeal mask was successfully inserted and fixed, and the cuff was inflated.

    With the child's head in a neutral position, OLP was measured by closing the expiratory valve of the circle system at a fixed gas flow of 3 l/minute, recording the airway pressure at which equilibrium was reached. Gas leakage was evaluated at the mouth (by detecting an audible sound) and stomach (by epigastric auscultation).

Secondary outcomes

  1. insertion time

    Time frame: The time to successful insertion was measured from the time of facemask removal until the time at which bilateral chest expansion was observed.

    The time to successful insertion was measured from the time of facemask removal until the time at which bilateral chest expansion was observed.

  2. grade of fibreoptic view

    Time frame: The grade of fibreoptic view was measured after the laryngeal mask was successfully inserted and fixed, and the cuff was inflated.

    The grade of fibreoptic view was assessed by fibreoptic bronchoscopy through the LMA and graded as follows: 1, full view of vocal cords; 2, partial view of vocal cords, including arytenoids; 3, epiglottis only; 4, other (e.g. LMA cuff, pharynx).

  3. postoperative sore throat

    Time frame: Immediately after the patient wakes up and 24 hours after surgery

    The patient said that he had sore throat after surgery

Sponsors and collaborators

Lead sponsor

Eye & ENT Hospital of Fudan University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 19, 2019
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.