Clinical trial NCT06337006: Laryngeal Mask Airway Failure in Pediatric Patients
Official title: Identification of Laryngeal Mask Airway Failure in Pediatric Patients With Objective Criteria: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Management
Keywords: Laryngeal mask airway
pediatric
surgery
Lead sponsor: Samsun University
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 66
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children using a Laryngeal mask for airway control during surgery

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the unsuccess of placement of the laryngeal mask airway
timeFrame: 15 minute
Secondary outcomes:
measure: The relationship between LMA placement failure and postoperative airway complications
timeFrame: 2 hour
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Samsun University
state: Canik
Study officials:
affiliation: Samsun University
name: OZGUR KOMURCU, 1
role: STUDY_DIRECTOR
References:
citation: Farbood A, Tayyebi G, Naderi-Boldaji V, Asmarian N. Comparison of the ease of insertion and complications of the classical method of laryngeal mask airway insertion with an alternative method. Saudi J Anaesth. 2023 Apr-Jun;17(2):182-186. doi: 10.4103/sja.sja_681_22. Epub 2023 Mar 10.
citation: Hernandez MR, Klock PA Jr, Ovassapian A. Evolution of the extraglottic airway: a review of its history, applications, and practical tips for success. Anesth Analg. 2012 Feb;114(2):349-68. doi: 10.1213/ANE.0b013e31823b6748. Epub 2011 Dec 16.
citation: Van Zundert AAJ, Gatt SP, Kumar CM, Van Zundert TCRV, Pandit JJ. 'Failed supraglottic airway': an algorithm for suboptimally placed supraglottic airway devices based on videolaryngoscopy. Br J Anaesth. 2017 May 1;118(5):645-649. doi: 10.1093/bja/aex093. No abstract available.