Laryngeal Masks ComparisonNCT07196137
Comparing the Effect of LTS and Air-Q sp3G LMA Use on Gastric Insufflation Using Ultrasound
An observational study of Laryngeal Masks Comparison and Elective Surgeries, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Laryngeal Masks Comparison, Elective Surgeries, Gastric Ultrasonography
- How many people
- 101 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Sep 2025to 29 Jan 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: ASA I-III class, ages between 1-12, patients who will undergo elective surgery under standard general anesthesia
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital Department of Anesthesiology and Reanimation
Ankara, Çankaya
About this study
Official title: Comparing the Effect of Laryngeal Tube Suction (LTS) and Air-Q sp3G Laryngeal Mask Airway (LMA) Use on Gastric Insufflation and Volume Using Ultrasound
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.
Read the detailed description
During general anesthesia, various devices are used to secure the airway. Supraglottic airway devices (SGAs) are among these and are used safely for short surgical procedures. Although SGAs are used to provide an easy and safe airway, none of them seal the trachea and ventilate only the lungs in the way that endotracheal intubation (ETT) does. Positive pressure ventilation provided at the supraglottic level cannot prevent air from escaping into the esophagus and, consequently, the stomach. Gastric distension is associated with perioperative complications such as nausea, vomiting, and aspiration, and is considered an undesirable condition by anesthesiologists.
The study aims to compare the Laryngeal Tube Suction and the Air Q sp3G Laryngeal Mask in terms of gastric insufflation. By measuring the diameters of the gastric antrum and recording their changes throughout the case, this study intend to evaluate the effectiveness and reliability of the two airway devices.
ASA (American Society of Anesthesiologist) I-III class pediatric patients between the ages of 1-12 who will undergo elective surgery under general anesthesia will be included in the study. Randomisation will be done with a sealed envelope. The blinded researcher will collect and record data without knowing which airway device was chosen. Blind researcher will do gastric ultrasound measurements with Butterfly IQ+ ultrasound. Another researcher will insert the airway device and after insertion patients head will be covered, this researcher will not involve during data collection. After the data is collected, the airway device releated data will be recorded by non-blind researcher seperately.
- Conditions
- Laryngeal Masks Comparison, Elective Surgeries, Gastric Ultrasonography, Gastric Insufflation
- Keywords
- Laryngeal Mask, Airway Management, Ultrasonography, Child
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: Just before the end of anesthesia, after the surgery is completed
Secondary outcomes (10)
LTS Cuff Pressure Measurement
If the choosen airway device is an LTS, after inserting LTS a cuff pressure measurement will be done by nonblind researcher. For masking the device that used even if a measurement is not taken, it will be treated as if it were.
Measured: Just after inserting a Laryngeal Tube Suction
Maximum Airway Pressure (PPeak)
The highest pressure measured by the mechanical ventilator will be recorded.
Measured: Intraoperative
Minimum Saturation
The lowest measured saturation value.
Measured: Intraoperative
Spasm
Incidence of spasm
Measured: Intraoperative and/or postoperative 2 hours
The time taken for airway device placement and failed placement
The time from the moment the airway device is touched until end-tidal CO2 is detected (Second)
Measured: Intraoperative
Postoperative Sore Throat
Incidence of sore throat assessed by direct questioning
Measured: Postoperative 2 hours
Postoperative Nausea and Vomitting
Incidence of post operative nausea and vomitting assessed by direct questioning
Measured: Postoperative 2 hours
Presence of blood on the supraglottic airway
Nonblinded researcher will check if there is blood contamination on the SGA after removing it.
Measured: Just after removing the SGA
Postoperative Cough
Incidence of Cough assessed by direct questioning or physical examination
Measured: Postoperative 2 hours
Need for nebulized medications or cool mist.
Need for nebulized medications or cool mist for spasm or cough
Measured: Postoperative 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start29 Sep 2025
- Primary completion2 Jan 2026
- Study completion29 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Laryngeal Masks ComparisonStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196137
- Sponsor's protocol ID
- E2-25-11500
- Status last verified
- Sep 2025
- First submitted
- 19 Aug 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29033724Gasteiger 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.
PubMed 27380049Genzwuerker 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.
PubMed 11738781Scheller 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.
PubMed 19410354Katzenschlager 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.
PubMed 39264430
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effect of Laryngeal Tube Suction (LTS) and Air-Q sp3G Laryngeal Mask Airway (LMA) Use on Gastric Insufflation and Volume Using Ultrasound
- ClinicalTrials.gov ID
- NCT07196137
- Acronym / sponsor ID
- E2-25-11500
- Conditions
- Laryngeal Masks Comparison, Elective Surgeries, Gastric Ultrasonography, Gastric Insufflation
- Keywords
- Laryngeal Mask, Airway Management, Ultrasonography, Child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 2 Jan 2026 (actual)
- Study completion
- 29 Jan 2026 (actual)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
During general anesthesia, various devices are used to secure the airway. Supraglottic airway devices (SGAs) are among these and are used safely for short surgical procedures. Although SGAs are used to provide an easy and safe airway, none of them seal the trachea and ventilate only the lungs in the way that endotracheal intubation (ETT) does. Positive pressure ventilation provided at the supraglottic level cannot prevent air from escaping into the esophagus and, consequently, the stomach. Gastric distension is associated with perioperative complications such as nausea, vomiting, and aspiration, and is considered an undesirable condition by anesthesiologists.
The study aims to compare the Laryngeal Tube Suction and the Air Q sp3G Laryngeal Mask in terms of gastric insufflation. By measuring the diameters of the gastric antrum and recording their changes throughout the case, this study intend to evaluate the effectiveness and reliability of the two airway devices.
ASA (American Society of Anesthesiologist) I-III class pediatric patients between the ages of 1-12 who will undergo elective surgery under general anesthesia will be included in the study. Randomisation will be done with a sealed envelope. The blinded researcher will collect and record data without knowing which airway device was chosen. Blind researcher will do gastric ultrasound measurements with Butterfly IQ+ ultrasound. Another researcher will insert the airway device and after insertion patients head will be covered, this researcher will not involve during data collection. After the data is collected, the airway device releated data will be recorded by non-blind researcher seperately.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- ASA I-III class, ages between 1-12, patients who will undergo elective surgery under standard general anesthesia
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gastric Antral Cross Sectional Area (T0)
Time frame: Just before anesthesia induction
First gastric measurement: Before anesthesia induction gastric ultrasound will be done and gastric antrum cross sectional area will be recorded by blinded researcher
Gastric Antral Cross Sectional Area (T1)
Time frame: Right after the SGA is placed following anesthesia induction.
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
Gastric Antral Cross Sectional Area (T2)
Time frame: Just before the end of anesthesia, after the surgery is completed
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.
10 secondary outcomes
LTS Cuff Pressure Measurement
Time frame: Just after inserting a Laryngeal Tube Suction
Maximum Airway Pressure (PPeak)
Time frame: Intraoperative
Minimum Saturation
Time frame: Intraoperative
Spasm
Time frame: Intraoperative and/or postoperative 2 hours
The time taken for airway device placement and failed placement
Time frame: Intraoperative
Postoperative Sore Throat
Time frame: Postoperative 2 hours
Postoperative Nausea and Vomitting
Time frame: Postoperative 2 hours
Presence of blood on the supraglottic airway
Time frame: Just after removing the SGA
Postoperative Cough
Time frame: Postoperative 2 hours
Need for nebulized medications or cool mist.
Time frame: Postoperative 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Background: PubMed 29033724Chandrakar 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.
- Background: PubMed 27380049Gasteiger 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.
- Background: PubMed 11738781Genzwuerker 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.
- Background: PubMed 19410354Scheller 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.
- Background: PubMed 39264430Katzenschlager 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.
- Individual participant dataSharing planned: No
Related trials for Laryngeal Masks Comparison
Not yet recruiting
Comparison of Second- and Third-Generation Laryngeal Mask Airway in Pediatric Patients
Airway Management, Anesthesia, General
RecruitingPhase 4
Propofol-Ketamine Versus Sevoflurane for Laryngeal Mask Anesthesia in Pediatric Cardiac Catheterization
Propofol, Ketamine
Not yet recruiting
Video Laryngeal Mask SaCoVLM Versus LMA Supreme and Ambu AuraGain in Children
Airway Management, Anesthesia, General
Not yet recruiting
SafeLM Versus LMA Classic for Airway Management During Fibroadenoma Excision
Airway Management
Not yet recruitingObservational study
Comparison of I-gel and SaCoVLM in Laparoscopic Cholecystectomy
Hemodynamic Monitoring, Laryngeal Mask Success Rate
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laryngeal Masks Comparison and Elective Surgeries, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric Antral Cross Sectional Area (T0) (time frame: Just before anesthesia induction). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07196137, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.