Laryngeal Mask Airway in ChildrenNCT01653795
A Comparison of the Laryngeal Mask Airway (LMA) - Unique and LMA-Supreme in Children
A study testing LMA Supreme: comparison device in people with Laryngeal Mask Airway in Children, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
The aim of this randomized prospective study is to compare two single-use laryngeal mask airways the LMA Unique and the LMA Supreme, in pediatric patients. The investigators hypothesize that airway leak pressures with the LMA Supreme will be superior to the LMA Unique. Read more about this study
- Who is it for?
- Ages 3 months to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Laryngeal Mask Airway in Children
- What is being tested?
- LMA Supreme: comparison device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Nov 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 months to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children undergoing general anesthesia using a supraglottic airway device
Who cannot join
- ASA class IV, V, Emergency procedures
- active respiratory infection
- known history of difficult mask ventilation
- a diagnosis of a congenital syndrome associated with difficult airway management
- airway abnormalities (e.g., laryngomalacia, subglottic stenosis)
- active gastrointestinal reflux
- coagulopathy
- clinically significant pulmonary disease(s)
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
Official title: A Randomized Trial Comparing the Laryngeal Mask Airway-Unique and Laryngeal Mask Airway-Supreme in Children
The aim of this randomized prospective study is to compare two single-use laryngeal mask airways the LMA Unique and the LMA Supreme, in pediatric patients. The investigators hypothesize that airway leak pressures with the LMA Supreme will be superior to the LMA Unique.
Read the detailed description
The goal of this study is to compare the LMA Unique and LMA-Supreme in children undergoing anesthesia. The investigators hypothesize that airway leak pressures with the LMA Supreme will be superior when compared with the LMA Unique at two different standardized intracuff pressures (40 and 60 cm H20). Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. The ease of placement, fiberoptic grade of laryngeal view, feasibility of use, and complications will also be assessed.
- Conditions
- Laryngeal Mask Airway in Children
- Being tested
- LMA Unique: control device, LMA Supreme: comparison device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMA Unique: control deviceDevice
Also called Laryngeal Mask Airway
LMA Unique will be placed in children based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, or 2.5. The size of the airway device will be determined according to the manufacturer's guidelines that are standardized by the patient's weight in kilograms.
LMA Supreme: comparison deviceDevice
Also called Laryngeal Mask Airway
LMA Supreme will be placed in children based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, or 2.5, The size of the airway device will be determined according to the manufacturer's guidelines that are standardized by the patient's weight in kilograms.
| Study group | Role | What they receive |
|---|---|---|
| LMA Unique | Active comparator | Not described Receives: Device: LMA Unique: control device |
| LMA Supreme | Active comparator | Not described Receives: Device: LMA Supreme: comparison device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway Leak Pressure
Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached when fresh gas flow is delivered at 3L/min when the pressure limiting valve is closed.
Measured: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Secondary outcomes (8)
Time to Secure the Airway
From picking up the airway device to bilateral chest expansion and presence of ETCO2
Measured: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Number of Attempts to Place the Device
Number of attempts needed for successful placement will be recorded (maximum of 3 attempts will be considered as a failure)
Measured: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Fiberoptic Grade of Laryngeal View
The laryngeal alignment through the devices will be graded using an established scoring system.
- Grade 1, larynx only seen;
- Grade 2, larynx and epiglottis posterior surface seen;
- Grade 3, larynx and epiglottis tip of anterior surface seen, <50% visual obstruction of epiglottis to larynx;
- Grade 4, epiglottis downfolded and its anterior surface seen, >50% visual obstruction of epiglottis to larynx;
- Grade 5, epiglottis downfolded and larynx cannot be seen directly
Measured: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Gastric Insufflation
The presence of gastric insufflations will be assessed during leak pressure testing by using epigastric auscultation
Measured: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Ease of Gastric Tube Placement (Only in Patients Who Receive LMA Supreme)
The ease of gastric placement will be timed and assessed using a subjective scale. Low scale scores indicate a better outcome. The LMA Unique does not contain a gastric port so this outcome will only be assessed in patients who received the LMA Supreme device.
- 1 = Easy
- 2 = Difficult
- 3 = Unable to Pass
Measured: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Quality of the Airway
The quality of hands free anesthesia will be assessed during maintenance of anesthesia using a subjective scale. Clear indicates a positive outcome while obstruction indicates a worse outcome.
- Clear
- Intermittent Partial Obstruction
- Intermittent Complete Obstruction
- Complete obstruction
Measured: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Incidence of Device Repositioning and/or Replacement
Intra-operative device repositioning or replacement of the device due to excessive air leak or airway obstruction, as evidenced by an obstructive pattern on the continuous end-tidal carbon dioxide monitor that leads to a decrease in oxygen saturation by pulse oximetry to less than 90%.
Measured: Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours
Postoperative Complications
Assessed by the subject's response or parents subjective assessment to standardized questions regarding oropharyngeal complaints such as sore throat, jaw pain, neck discomfort.
Measured: Measured at 24 hours after device placement/study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Laryngeal Mask Airway in ChildrenStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Narasimhan Jagannathan, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653795
- Sponsor's protocol ID
- LMA-U vs SLMA (multiple sizes)
- Status last verified
- Oct 2026
- First submitted
- 27 Jul 2012
- Last updated
- 16 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Jagannathan N, Sohn LE, Sawardekar A, Gordon J, Langen KE, Anderson K. A randomised comparison of the LMA SupremeTM and LMAProSealTM in children. Anaesthesia. 2012 Jun;67(6):632-9. doi: 10.1111/j.1365-2044.2012.07088.x. Epub 2012 Mar 15.
PubMed 22420717Jagannathan N, Sohn LE, Chang E, Sawardekar A. A cohort evaluation of the laryngeal mask airway-Supreme in children. Paediatr Anaesth. 2012 Aug;22(8):759-64. doi: 10.1111/j.1460-9592.2012.03832.x. Epub 2012 Mar 15.
PubMed 22416790Jagannathan N, Sohn LE, Sawardekar A, Chang E, Langen KE, Anderson K. A randomised trial comparing the laryngeal mask airway Supreme with the laryngeal mask airway Unique in children. Anaesthesia. 2012 Feb;67(2):139-44. doi: 10.1111/j.1365-2044.2011.06960.x. Epub 2011 Nov 9.
PubMed 22070630Lee JR, Kim MS, Kim JT, Byon HJ, Park YH, Kim HS, Kim CS. A randomised trial comparing the i-gel (TM) with the LMA Classic (TM) in children. Anaesthesia. 2012 Jun;67(6):606-11. doi: 10.1111/j.1365-2044.2012.07072.x. Epub 2012 Feb 21.
PubMed 22352745Goyal R, Shukla RN, Kumar G. Comparison of size 2 i-gel supraglottic airway with LMA-ProSeal and LMA-Classic in spontaneously breathing children undergoing elective surgery. Paediatr Anaesth. 2012 Apr;22(4):355-9. doi: 10.1111/j.1460-9592.2011.03757.x. Epub 2011 Dec 8.
PubMed 22151106Beringer RM, Kelly F, Cook TM, Nolan J, Hardy R, Simpson T, White MC. A cohort evaluation of the paediatric i-gel() airway during anaesthesia in 120 children. Anaesthesia. 2011 Dec;66(12):1121-6. doi: 10.1111/j.1365-2044.2011.06884.x. Epub 2011 Sep 1.
PubMed 21883132
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing the Laryngeal Mask Airway-Unique and Laryngeal Mask Airway-Supreme in Children
- ClinicalTrials.gov ID
- NCT01653795
- Acronym / sponsor ID
- LMA-U vs SLMA (multiple sizes)
- Conditions
- Laryngeal Mask Airway in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 31 Jul 2012 (estimated)
- Results
- Posted 16 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this randomized prospective study is to compare two single-use laryngeal mask airways the LMA Unique and the LMA Supreme, in pediatric patients. The investigators hypothesize that airway leak pressures with the LMA Supreme will be superior to the LMA Unique.
Detailed description
The goal of this study is to compare the LMA Unique and LMA-Supreme in children undergoing anesthesia. The investigators hypothesize that airway leak pressures with the LMA Supreme will be superior when compared with the LMA Unique at two different standardized intracuff pressures (40 and 60 cm H20). Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. The ease of placement, fiberoptic grade of laryngeal view, feasibility of use, and complications will also be assessed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LMA Unique | Active comparator | Device: LMA Unique: control device |
| LMA Supreme | Active comparator | Device: LMA Supreme: comparison device |
Who may qualify
- Ages
- 3 months to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children undergoing general anesthesia using a supraglottic airway device
Key exclusion criteria (8 listed)
- ASA class IV, V, Emergency procedures
- active respiratory infection
- known history of difficult mask ventilation
- a diagnosis of a congenital syndrome associated with difficult airway management
- airway abnormalities (e.g., laryngomalacia, subglottic stenosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LMA Unique: control deviceAlso: Laryngeal Mask AirwayLMA Unique will be placed in children based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, or 2.5. The size of the airway device will be determined according to the manufacturer's guidelines that are standardized by the patient's weight in kilograms. | Device | LMA Unique |
| LMA Supreme: comparison deviceAlso: Laryngeal Mask AirwayLMA Supreme will be placed in children based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, or 2.5, The size of the airway device will be determined according to the manufacturer's guidelines that are standardized by the patient's weight in kilograms. | Device | LMA Supreme |
Primary outcome
Airway Leak Pressure
Time frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached when fresh gas flow is delivered at 3L/min when the pressure limiting valve is closed.
8 secondary outcomes
Time to Secure the Airway
Time frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Number of Attempts to Place the Device
Time frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Fiberoptic Grade of Laryngeal View
Time frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Gastric Insufflation
Time frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Ease of Gastric Tube Placement (Only in Patients Who Receive LMA Supreme)
Time frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Quality of the Airway
Time frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Incidence of Device Repositioning and/or Replacement
Time frame: Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours
Postoperative Complications
Time frame: Measured at 24 hours after device placement/study initiation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22420717Jagannathan N, Sohn LE, Sawardekar A, Gordon J, Langen KE, Anderson K. A randomised comparison of the LMA SupremeTM and LMAProSealTM in children. Anaesthesia. 2012 Jun;67(6):632-9. doi: 10.1111/j.1365-2044.2012.07088.x. Epub 2012 Mar 15.
- Background: PubMed 22416790Jagannathan N, Sohn LE, Chang E, Sawardekar A. A cohort evaluation of the laryngeal mask airway-Supreme in children. Paediatr Anaesth. 2012 Aug;22(8):759-64. doi: 10.1111/j.1460-9592.2012.03832.x. Epub 2012 Mar 15.
- Background: PubMed 22070630Jagannathan N, Sohn LE, Sawardekar A, Chang E, Langen KE, Anderson K. A randomised trial comparing the laryngeal mask airway Supreme with the laryngeal mask airway Unique in children. Anaesthesia. 2012 Feb;67(2):139-44. doi: 10.1111/j.1365-2044.2011.06960.x. Epub 2011 Nov 9.
- Background: PubMed 22352745Lee JR, Kim MS, Kim JT, Byon HJ, Park YH, Kim HS, Kim CS. A randomised trial comparing the i-gel (TM) with the LMA Classic (TM) in children. Anaesthesia. 2012 Jun;67(6):606-11. doi: 10.1111/j.1365-2044.2012.07072.x. Epub 2012 Feb 21.
- Background: PubMed 22151106Goyal R, Shukla RN, Kumar G. Comparison of size 2 i-gel supraglottic airway with LMA-ProSeal and LMA-Classic in spontaneously breathing children undergoing elective surgery. Paediatr Anaesth. 2012 Apr;22(4):355-9. doi: 10.1111/j.1460-9592.2011.03757.x. Epub 2011 Dec 8.
- Background: PubMed 21883132Beringer RM, Kelly F, Cook TM, Nolan J, Hardy R, Simpson T, White MC. A cohort evaluation of the paediatric i-gel() airway during anaesthesia in 120 children. Anaesthesia. 2011 Dec;66(12):1121-6. doi: 10.1111/j.1365-2044.2011.06884.x. Epub 2011 Sep 1.
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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.
Narasimhan Jagannathan, MD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LMA Supreme: comparison device in people with Laryngeal Mask Airway in Children, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
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 1 inclusion and 8 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 16 Oct 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 United States. 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?
Yes. Results are posted in the registry (first posted 16 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Airway Leak Pressure (time frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours). 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 NCT01653795, which also lists 6 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 16 Oct 2026.