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

NCT03845998 | Completed

• 1 other identifier: 2017059-1
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Airway Management

Keywords

airway; anaesthesia; laryngeal mask airway; paediatric

Outcome Measures

Primary Outcomes (1)

• oropharyngeal leak pressure (OLP)

  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).

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

Secondary Outcomes (3)

• insertion time

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

• grade of fibreoptic view

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

• postoperative sore throat

  Immediately after the patient wakes up and 24 hours after surgery

Study Arms (2)

three-finger method

EXPERIMENTAL

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. That is what we call the three-finger method. The intervention is to use the three-finger method.

Procedure: use the three-finger method

weight-related method

ACTIVE COMPARATOR

The size of the laryngeal mask airway for each patient was determined by the manufacturer's weight-related guidelines. That is what we call the weight-related method. The intervention is to use the weight-related method.

Procedure: use the weight-related method

Interventions

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.

three-finger method

use the weight-related method PROCEDURE

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

weight-related method

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Jie Jia

Shanghai, 021, China

Location

Related Publications (2)

• Gallart L, Mases A, Martinez J, Montes A, Fernandez-Galinski S, Puig MM. Simple method to determine the size of the laryngeal mask airway in children. Eur J Anaesthesiol. 2003 Jul;20(7):570-4. doi: 10.1017/s0265021503000917.

  PMID: 12884992 BACKGROUND

• Kapila A, Addy EV, Verghese C, Brain AI. The intubating laryngeal mask airway: an initial assessment of performance. Br J Anaesth. 1997 Dec;79(6):710-3. doi: 10.1093/bja/79.6.710.

  PMID: 9496200 BACKGROUND

Study Officials

• Jie Jia

  Eye & ENT Hospital of Fudan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: February 16, 2019
• First Posted: February 19, 2019
• Study Start: February 25, 2019
• Primary Completion: May 1, 2019
• Study Completion: May 25, 2019
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)