Laryngeal Masks in ChildrenNCT01633073
A Comparison of the Laryngeal Mask Airway (LMA) Supreme and I-gel in Children
A study testing i-gel: comparison device in people with Laryngeal Masks 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 with a provision of a gastric drain tube allowing for evacuation of gastric contents, the i-gel and the LMA Supreme, in pediatric patients undergoing positive pressure ventilation. 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 Masks in Children
- What is being tested?
- i-gel: comparison device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Sep 2012
- Phase
- Interventional
- 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 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
- weight 5-50 kg
- age 3 months-11 years
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-SupremeTM With the i-gelTM in Children
The aim of this randomized prospective study is to compare two single-use laryngeal mask airways with a provision of a gastric drain tube allowing for evacuation of gastric contents, the i-gel and the LMA Supreme, in pediatric patients undergoing positive pressure ventilation. The investigators hypothesize that airway leak pressures with the i-gel will not be significantly different clinically (higher) when compared with the LMA Supreme.
Read the detailed description
The goal of this study is to compare the LMA Supreme and i-gel in children having surgery. The investigators hypothesize that airway leak pressures with the i-gel will not be significantly different clinically (higher) when compared with the LMA Supreme. 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 during positive pressure ventilation, ease of gastric tube placement, and complications (airway related, gastric insufflation, and trauma) will also be assessed.
- Conditions
- Laryngeal Masks in Children
- Being tested
- LMA Supreme: control device, i-gel: comparison device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMA Supreme: control deviceDevice
Also called laryngeal mask airway
LMA Supreme will be placed in children weighing 5-50kg based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, 2.5, or 3.0. 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.
i-gel: comparison deviceDevice
Also called laryngeal mask airway
i-gel will be placed in children weighing 5-50kg based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, 2.5, or 3.0. 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 Supreme | Active comparator | Not described Receives: Device: LMA Supreme: control device |
| i-gel | Active comparator | Not described Receives: Device: i-gel: 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 (10)
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
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
The ease of gastric placement will be timed and assessed using a subjective scale
Measured: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Feasibility of positive pressure ventilation
Peak inspiratory pressure and tidal volumes will be recorded. Maximum peak inspiratory pressure will be the airway leak pressure was determined for each patient
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 previously described scale
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
Oropharyngolaryngeal morbidity at discharge
Assessed by the subject's response or parents subjective assesment to standardized questions regarding oropharyngeal complaints such as sore throat, jaw pain, neck discomfort.
Measured: Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours
Oropharyngolaryngeal morbidity at 24 hours post-operatively
Assessed by the subject's response or parents subjective assesment 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 posted4 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Laryngeal Masks 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Narasimhan Jagannathan, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Narasimhan Jagannathan, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633073
- Sponsor's protocol ID
- SLMA vs i-gel
- Status last verified
- Oct 2012
- First submitted
- 28 Jun 2012
- Last updated
- 2 Oct 2012
- Results posted
- No
- 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 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing the Laryngeal Mask Airway-SupremeTM With the i-gelTM in Children
- ClinicalTrials.gov ID
- NCT01633073
- Acronym / sponsor ID
- SLMA vs i-gel
- Conditions
- Laryngeal Masks in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 4 Jul 2012 (estimated)
- 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 aim of this randomized prospective study is to compare two single-use laryngeal mask airways with a provision of a gastric drain tube allowing for evacuation of gastric contents, the i-gel and the LMA Supreme, in pediatric patients undergoing positive pressure ventilation. The investigators hypothesize that airway leak pressures with the i-gel will not be significantly different clinically (higher) when compared with the LMA Supreme.
Detailed description
The goal of this study is to compare the LMA Supreme and i-gel in children having surgery. The investigators hypothesize that airway leak pressures with the i-gel will not be significantly different clinically (higher) when compared with the LMA Supreme. 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 during positive pressure ventilation, ease of gastric tube placement, and complications (airway related, gastric insufflation, and trauma) will also be assessed.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LMA Supreme | Active comparator | Device: LMA Supreme: control device |
| i-gel | Active comparator | Device: i-gel: comparison device |
Who may qualify
- Ages
- 3 months to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children undergoing general anesthesia using a supraglottic airway device
- weight 5-50 kg
- age 3 months-11 years
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 Supreme: control deviceAlso: laryngeal mask airwayLMA Supreme will be placed in children weighing 5-50kg based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, 2.5, or 3.0. 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 |
| i-gel: comparison deviceAlso: laryngeal mask airwayi-gel will be placed in children weighing 5-50kg based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, 2.5, or 3.0. 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 | i-gel |
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.
10 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
Time frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Feasibility of positive pressure ventilation
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
Oropharyngolaryngeal morbidity at discharge
Time frame: Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours
Oropharyngolaryngeal morbidity at 24 hours post-operatively
Time frame: Measured at 24 hours after device placement/study initiation
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 2 Oct 2012.
- 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.
Related trials for Laryngeal Masks in Children
Not yet recruiting
Video Laryngeal Mask SaCoVLM Versus LMA Supreme and Ambu AuraGain in Children
Airway Management, Anesthesia, General
RecruitingPhase 4
The ED95 of Ciprofol for Laryngeal Mask Airway Insertion With Fentanyl in Children: A Biased-Coin Dose-Finding Trial
Pediatric, Anesthesia Induction
Recruiting
Comparing Different Startegies of Positive Pressure Ventilation in Children
Ventilation Therapy; Complications
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 i-gel: comparison device in people with Laryngeal Masks 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 3 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 2 Oct 2012. 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?
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?
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 NCT01633073, 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 2 Oct 2012.