Laryngeal Mask Airway Failure in Pediatric Patients

NCT06337006 | Completed

• 1 other identifier: SÜKAEK 2023/15/13
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Management

Keywords

Laryngeal mask airway; pediatric; surgery

Outcome Measures

Primary Outcomes (1)

• Evaluation of the unsuccess of placement of the laryngeal mask airway

  Identification of variables associated with unsuccessful LMA placement

  15 minute

Secondary Outcomes (1)

• The relationship between LMA placement failure and postoperative airway complications

  2 hour

Study Arms (2)

Group S

The LMA was successfully placed after the first attempt.

Procedure: Placement of the laryngeal mask airway

Group non-S

The LMA was not placed successfully after the first attempt.

Procedure: Placement of the laryngeal mask airway

Interventions

Placement of the laryngeal mask airway PROCEDURE

Evaluation of patients' chest movement with manual ventilation, airway leak level, airway pressures, fingertip O2 saturation percentage, and capnogram results will be recorded and the correlation between clinical observation and measured parameters will be evaluated.

Group S; Group non-S

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children using a Laryngeal mask for airway control during surgery

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsun University: lead

Study Sites (1)

Samsun University

Samsun, Samsun, 55090, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 37260649 BACKGROUND

• 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.

  PMID: 22178627 BACKGROUND

• 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.

  PMID: 28510747 BACKGROUND

Study Officials

• OZGUR KOMURCU, 1

  Samsun University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 29, 2024
• Study Start: September 15, 2023
• Primary Completion: June 25, 2024
• Study Completion: July 1, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)