Comparing the Effect of LTS and Air-Q sp3G LMA Use on Gastric Insufflation Using Ultrasound

NCT07196137 | Completed

• 1 other identifier: E2-25-11500
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to evaluate gastric insufflation during the use of two different airway devices (Laringeal Tube Suction and Air Q sp3G Laryngeal Mask. The secondary objectives of the study are to assess these two airway devices in terms of perioperative complications.

Conditions

Elective Surgeries; Gastric Ultrasonography; Gastric Insufflation; Laryngeal Masks Comparison

Keywords

Laryngeal Mask; Airway Management; Ultrasonography; Child

Outcome Measures

Primary Outcomes (3)

• Gastric Antral Cross Sectional Area (T0)

  First gastric measurement: Before anesthesia induction gastric ultrasound will be done and gastric antrum cross sectional area will be recorded by blinded researcher

  Just before anesthesia induction

• Gastric Antral Cross Sectional Area (T1)

  Second gastric measurement: after anesthesia induction and before the start of surgery gastric ultrasound will be done and gastric antrum cross sectional area will be recorded by blinded researcher

  Right after the SGA is placed following anesthesia induction.

• Gastric Antral Cross Sectional Area (T2)

  Third measurement: Just before the end of anesthesia, after the surgery is completed gastric ultrasound will be done and gastric antrum cross sectional area will be recorded by blinded researcher.

  Just before the end of anesthesia, after the surgery is completed

Secondary Outcomes (10)

• LTS Cuff Pressure Measurement

  Just after inserting a Laryngeal Tube Suction

• Maximum Airway Pressure (PPeak)

  Intraoperative

• Minimum Saturation

  Intraoperative

• Spasm

  Intraoperative and/or postoperative 2 hours

• The time taken for airway device placement and failed placement

  Intraoperative

Study Arms (2)

AIRQ

After obtaining consent, patients will be asked to choose their airway device using a sealed envelope method. The patients' demographic data and ASA scores will be recorded. Gastric antrum diameters will be recorded at the beginning of the case, before induction. After the airway device is placed, the antrum diameters will be recorded. The antrum diameters will be recorded again after the surgery is complete, before the airway device is removed. Mechanical ventilator settings will be recorded. To ensure standardization, the tidal volume will be set to 7 ml per kg. No PEEP will be applied. Volume-controlled ventilation will be used. The lowest intraoperative saturation and the highest peak pressure that occurred will be recorded.The cuff pressure will be recorded after being inflated with the recommended volume. The time taken for airway device placement (the time from when it is picked up until Endtidal CO2 is observed) and any failed placements will be recorded.

LTS

After obtaining consent, patients will be asked to choose their airway device using a sealed envelope method. The patients' demographic data and ASA scores will be recorded. Gastric antrum diameters will be recorded at the beginning of the case, before induction. After the airway device is placed, the antrum diameters will be recorded. The antrum diameters will be recorded again after the surgery is complete, before the airway device is removed. Mechanical ventilator settings will be recorded. To ensure standardization, the tidal volume will be set to 7 ml per kg. No PEEP will be applied. Volume-controlled ventilation will be used. The lowest intraoperative saturation and the highest peak pressure that occurred will be recorded.The cuff pressure will be recorded after being inflated with the recommended volume. The time taken for airway device placement (the time from when it is picked up until Endtidal CO2 is observed) and any failed placements will be recorded.

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

ASA I-III class, ages between 1-12, patients who will undergo elective surgery under standard general anesthesia

You may qualify if:

• Patients with an ASA score of I-III for whom a supraglottic airway (SGA) is planned.
• Operation time less than 2 hours. Patients who have read and accepted the informed consent form. Patients between the ages of 1 and 12, or their guardians, will be included in the study.

You may not qualify if:

• Patients who do not meet perioperative fasting criteria. Patients whose stomachs are not considered empty during the initial gastric ultrasound.
• Patients with a known difficult airway. Patients with oropharyngeal or laryngeal anomalies. Patients who require the use of neuromuscular blockers. Patients with a history of a previously failed SGA placement. Patients with known reflux. Patients who do not give consent will not be included in the study.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital Department of Anesthesiology and Reanimation

Ankara, Çankaya, Turkey (Türkiye)

Location

Related Publications (5)

• Chandrakar S, Sreevastava DK, Bhasin S, Dhar M. Comparison of laryngeal tube suction II and proseal LMA in pediatric patients, undergoing elective surgery. Saudi J Anaesth. 2017 Oct-Dec;11(4):432-436. doi: 10.4103/sja.SJA_418_17.

  PMID: 29033724 BACKGROUND

• Gasteiger L, Ofner S, Stogermuller B, Ziegler B, Brimacombe J, Keller C. Randomized crossover study assessing oropharyngeal leak pressure and fiber optic positioning : Laryngeal Mask Airway Supreme versus Laryngeal Tube LTS II size 2 in non-paralyzed anesthetized children. Anaesthesist. 2016 Aug;65(8):585-9. doi: 10.1007/s00101-016-0192-1.

  PMID: 27380049 BACKGROUND

• Genzwuerker HV, Finteis T, Slabschi D, Groeschel J, Ellinger K. Assessment of the use of the laryngeal tube for cardiopulmonary resuscitation in a manikin. Resuscitation. 2001 Dec;51(3):291-6. doi: 10.1016/s0300-9572(01)00410-5.

  PMID: 11738781 BACKGROUND

• Scheller B, Schalk R, Byhahn C, Peter N, L'Allemand N, Kessler P, Meininger D. Laryngeal tube suction II for difficult airway management in neonates and small infants. Resuscitation. 2009 Jul;80(7):805-10. doi: 10.1016/j.resuscitation.2009.03.029. Epub 2009 May 2.

  PMID: 19410354 BACKGROUND

• Katzenschlager S, Mohr S, Kaltschmidt N, Peterstorfer F, Weilbacher F, Gunther P, Ries M, Weigand MA, Popp E. Laryngeal mask vs. laryngeal tube trial in paediatric patients (LaMaTuPe): a single-blinded, open-label, randomised-controlled trial. Eur J Emerg Med. 2025 Apr 1;32(2):123-130. doi: 10.1097/MEJ.0000000000001178. Epub 2024 Sep 12.

  PMID: 39264430 BACKGROUND

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: August 19, 2025
• First Posted: September 29, 2025
• Study Start: September 29, 2025
• Primary Completion: January 2, 2026
• Study Completion: January 29, 2026
• Last Updated: February 2, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)