Hyomental Distance Measured Ultrasonography Versus Weight-based Criteria for Laryngeal Mask Size Selection in Children

NCT05832944 | Unknown

• 1 other identifier: MKSU 51-2-18
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

• In pediatric surgery and emergencies, LMA represents a useful airway management device for routine and difficult airway management.
• Inserting an improper LMA size may result in malposition, displacement within the hypopharynx, and failed ventilation that needs repositioning.
• Selection of the size of LMA represents a major challenge for anesthesiologists, especially in children.
• The ultrasonographic measured hyomental distance showed a correlation with the length of the pharyngeal cavity.
• Optimization of the size of the inserted LMA can be confirmed either clinically, ultrasonographic or through the fiberoptic laryngoscope.
• The ultrasonographic measured hyomental distance confirmed the optimization of LMA with results comparable to that of the clinical methods and better than those of the fiberoptic laryngoscope.

Conditions

Laryngeal Mask Airway

Keywords

hyomental distance; children

Outcome Measures

Primary Outcomes (1)

• correct size selection of LMA

  * A five-point scale will be used to evaluate the ease of LMA insertion from 1 to 5, considering that 1 corresponds to (inserted without resistance) and 5 corresponds to (impossible to insert).

  During LMA insertion (5 minutes duration)

Secondary Outcomes (3)

• Values of oropharyngeal leak pressure (OLP) after airway management

  During 30 minutes after LMA insertion

• postoperative oral injury

  After removal of LMA for 5 minutes

• many insertion attempts

  During LMA insertion attempts for 5 minutes

Study Arms (2)

Group HMD (30 patients)

EXPERIMENTAL

where the size of LMA will be according to measured hyomental distance by ultrasound as follows: * If Less than 2 cm: LMA size 2 will be used. * If 2-3 cm: LMA size 2.5 will be used. * If more than 3 cm: LMA size 3 will be used.

Device: ultrasound guided hyomental distance

Group CONTROL (30 patients)

NO INTERVENTION

where size selection will be based on the weight guide

Interventions

ultrasound guided hyomental distance DEVICE

measuring the hyomental distance by ultrasound guidance

Group HMD (30 patients)

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parents' acceptance
• Age: between 5-14 years
• Physical Status: American Society of Anesthesiologists (ASA) I \& II)

You may not qualify if:

• Developmental Delay (mental and physical growth retardation).
• Hypersensitivity to any type of used drugs.
• Patient with a difficult airway ( according to thyromental height and the Mallampati test)
• Patients with a history of neck surgery
• Airway malformation.
• Upper respiratory tract infection.
• Surgeries that will take up to more than forty-five minutes.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

kafrelsheikh university, Faculty of Medicine

Cairo, 00000, Egypt

RECRUITING

Study Officials

• AHMED A SHAMA, MD

  Assistant professor of anesthesia in Tanta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AHMED A SHAMA, MD

CONTACT

0580925443; ahmed.shama@med.tanta.edu.eg

SHERIF K ARAFA, MD

CONTACT

0580925443; sherifhafez1980@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blinded
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: April 16, 2023
• First Posted: April 27, 2023
• Study Start: June 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: January 1, 2024
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)