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Laryngeal Mask Airway Failure in Pediatric Patients

S

Samsun University

Status

Completed

Conditions

Airway Management

Treatments

Procedure: Placement of the laryngeal mask airway

Study type

Observational

Funder types

Other

Identifiers

NCT06337006
SÜKAEK 2023/15/13

Details and patient eligibility

About

There are a significant number of studies identifying risk factors for misplacement of LMAs. However, despite objective data indicating that tracheal intubation is performed inappropriately, such as air leaks, high air pressures, insufficient lung ventilation and single lung ventilation, which are easily identified after tracheal intubation, there are no objective data to define the misplacement of LMAs.

The aim of the study was to describe unsuccessful LMA placement in pediatric patients with objective data.

Full description

Optimal use of extraglottic airways, including the laryngeal mask (LMA), has not been fully defined using real-world data. Usage patterns and the reported incidence of failure and complications in different geographic regions vary greatly. In the adult population, an observational study involving more than 15,000 cases revealed a 1.1% incidence of laryngeal mask failure, defined as intubation after laryngeal mask removal, and 62% of patients experienced significant airway complications.

Similar data are scarce in children. Pediatric laryngeal mask studies report adverse event frequencies ranging from 0% to 10%. These data are limited by the focus on specific surgical procedures or the small sample size resulting in simple univariate or inadequate multivariate analyses. Additionally, although data on adverse events are presented, laryngeal mask failure requiring endotracheal intubation has been reported infrequently.

There are a significant number of studies identifying risk factors for misplacement of LMAs. However, there are no objective data to define misplacement of LMAs.

1-2 mL of lidocaine gel was applied evenly to the classic LMA (Intavent Direct, Maidenhead, UK) capsule. The appropriate size of the LMA device (size 1.5 for 5-10 kg and size 2 for 10-20 kg) was selected according to the manufacturer's recommendation. The LMA was placed by an experienced anesthesiologist, with the patient's head in a neutral position, with a fully deflated cuff, and the patient's mouth was opened, then held parallel to the chest, and the device was advanced along the hard palate. The cuff of the device was inflated with a sufficient amount of air according to the manufacturer's instructions. After LMA placement, patients were divided into two groups as successful (Group S) or unsuccessful (Group non-S) according to bilateral equal chest movement during inspiration, square wave capnography, absence of gastric insufflation, epigastrium auscultation and adequate tidal volume delivery. Another experienced anesthesiologist recorded the set (8 mL/kg) tidal volume (VT), expiratory tidal volume, airway peak pressure, SpO2, EtCO2 measurements in three respiratory cycles. Airway leak (ΔVT); It was calculated by subtracting expiratory VT from the adjusted VT. Airway leak, airway peak pressure, SpO2 and EtCO2 measurement were determined as possible objective predictors for LMA placement failure. Postoperative airway complications; It was determined and recorded as soft tissue trauma, laryngospasm, bronchospasm, and severe cough attack.

The aim of the study was to describe unsuccessful LMA placement in pediatric patients with objective data.

Enrollment

66 patients

Sex

All

Ages

2 to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • During surgery, the upper airway is planned to be supported with LMA by the Anesthesiologist.
  • American Society of Anesthesiologists (ASA) physical status I or II

Exclusion criteria

  • Surgery duration longer than 1 hour,
  • Airway difficulty is expected,
  • Restriction in opening the mouth,
  • Airway malformation,
  • Active upper respiratory tract infections,
  • History of narrow airway,
  • Hyperthyroidism, goiter, airway mass,
  • Patients at risk of gastroesophageal reflux and aspiration of stomach contents

Trial design

66 participants in 2 patient groups

Group S
Description:
The LMA was successfully placed after the first attempt.
Treatment:
Procedure: Placement of the laryngeal mask airway
Group non-S
Description:
The LMA was not placed successfully after the first attempt.
Treatment:
Procedure: Placement of the laryngeal mask airway

Trial contacts and locations

1

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Central trial contact

Hatice SELCUK KUSDERCI, 1; OZGUR KOMURCU, 2

Data sourced from clinicaltrials.gov

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