Supraglottic AirwayNCT02380768
A Comparison of the Ambu AuraGain Versus LMA Supreme in Children
A study testing Ambu AuraGain (size 1.5 or size 2.0) and LMA Supreme (size 1.5 or size 2.0) in people with Supraglottic Airway, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to determine whether there is a clinically relevant difference in airway leak pressures between the Ambu AuraGain and the Laryngeal Mask Airway (LMA) Supreme. Read more about this study
- Who is it for?
- Ages 3 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Supraglottic Airway
- What is being tested?
- Ambu AuraGain (size 1.5 or size 2.0) and LMA Supreme (size 1.5 or size 2.0)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jun 2015
- 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 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Scheduled for surgery utilizing a supraglottic airway device
- ASA (American Society of Anesthesiologists) I-III classification
- Weighing between 5 - 20 kilograms
Who cannot join
- Active respiratory infection
- History of difficult mask ventilation
- Diagnosis of congenital syndrome with difficult airway management
- Active gastrointestinal reflux
- Coagulopathy
- Significant Pulmonary disease
- Emergent surgery
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 Comparison of the Ambu AuraGain™ and LMA Supreme™ in Infants and Children
The purpose of this study is to determine whether there is a clinically relevant difference in airway leak pressures between the Ambu AuraGain and the Laryngeal Mask Airway (LMA) Supreme.
Read the detailed description
The goal of this prospective randomized study is to compare whether there is a clinically relevant difference in airway leak pressures between the Ambu AuraGain (sizes 1.5 and 2) and the Laryngeal Mask Airway (LMA) Supreme. Parameters of clinical relevance such as insertion success rates, fiberoptic view of the glottic opening, ease and speed of gastric tube placement, airway stability, and peri-operative complications will also be assessed.
- Conditions
- Supraglottic Airway
- Being tested
- Ambu AuraGain (size 1.5 or size 2.0), LMA Supreme (size 1.5 or size 2.0)
- Keywords
- Supraglottic airway, Laryngeal mask airway, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambu AuraGain (size 1.5 or size 2.0)Device
Also called Ambu AuraGain
The device will be inserted and timed. A leak pressure test will be performed after successful insertion and after 10 minutes. The larynx will be visualized by placing a fiberoptic bronchoscope through the device. A gastric tube will be inserted through the device and timed.
LMA Supreme (size 1.5 or size 2.0)Device
Also called LMA Supreme
The device will be inserted and timed. A leak pressure test will be performed after successful insertion and after 10 minutes. The larynx will be visualized by placing a fiberoptic bronchoscope through the device. A gastric tube will be inserted through the device and timed.
| Study group | Role | What they receive |
|---|---|---|
| Ambu AuraGain | Experimental | Subjects will receive the Ambu AuraGain size 1.5 or 2.0 based on manufacturer guidelines Receives: Device: Ambu AuraGain (size 1.5 or size 2.0) |
| LMA Supreme | Active comparator | Subjects will receive the Ambu AuraGain size 1.5 or 2.0 based on manufacturer guidelines Receives: Device: LMA Supreme (size 1.5 or size 2.0) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal (airway) leak pressure - Initial
The airway pressure at which an airway leak is observed after successful placement of the supraglottic airway
Measured: Assessed intraoperatively at the time of confirmed device placement
Oropharyngeal (airway) leak pressure - 10 Minutes
The airway pressure at which an airway leak is observed 10 minutes after successful placement of the supraglottic airway
Measured: Assessed intraoperatively, 10 minutes after the initial confirmed placement of the device
Secondary outcomes (8)
Time for Successful Placement of the Supraglottic Airway
Time for successful placement of supraglottic device will be recorded
Measured: Assessed intraoperatively at the time of confirmed device placement
Number of attempts to placement of Supraglottic Airway
Number of attempts and insertion techniques will be recorded (maximum of 3 attempts)
Measured: Assessed intraoperatively at the time of confirmed device placement
Fiberoptic Grade of Laryngeal View through Supraglottic Airway
Fiberoptic Grade of Laryngeal View through either device will be graded using a previously published grading system
Measured: Assessed intraoperatively at the time of confirmed device placement
Gastric Tube Insertion Ease of Placement
The ease of placement, based on a 1-4 scale, will be recorded following placement and confirmation of the gastric tube.
Measured: Assessed intraoperatively at the time of confirmed gastric tube placement
Gastric Tube Insertion Time
The elapsed time from beginning insertion of the gastric tube to confirmation, will be recorded. Confirmation of gastric tube placement will be determined by injection of air with auscultation (listening for sounds) over the stomach with a stethoscope.
Measured: Assessed intraoperatively at the time of confirmed gastric tube placement
Gastric Tube Insertion Attempts
Number of insertion attempts of the gastric tube through the SGA will be recorded. Confirmation of gastric tube placement will be determined by injection of air with auscultation (listening for sounds) over the stomach with a stethoscope.
Measured: Assessed intraoperatively at the time of confirmed gastric tube placement
Postoperative Complications
Patient will be evaluated for sore throat, cough, dysphonia, stridor, or other airway related complications during the post-operative period.
Measured: Participants will be followed for the duration of hospital stay. Outcome measure will be assessed postoperatively in recovery unit.
Intraoperative Complications
Complications such as reflex activation of the airway (coughing, breath holding, laryngospasm, bronchospasm), oxygen desaturation will be recorded, if they occur.
Measured: Assessed intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Supraglottic AirwayStudies 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
- None (open label)
- Enrolment
- 100 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, M.D., Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380768
- Sponsor's protocol ID
- IRB 2015-252
- Status last verified
- Jul 2015
- First submitted
- 26 Feb 2015
- Last updated
- 20 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
White MC, Cook TM, Stoddart PA. A critique of elective pediatric supraglottic airway devices. Paediatr Anaesth. 2009 Jul;19 Suppl 1:55-65. doi: 10.1111/j.1460-9592.2009.02997.x.
PubMed 19572845Jagannathan N, Ramsey MA, White MC, Sohn L. An update on newer pediatric supraglottic airways with recommendations for clinical use. Paediatr Anaesth. 2015 Apr;25(4):334-45. doi: 10.1111/pan.12614. Epub 2015 Jan 13.
PubMed 25585975Jagannathan 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 L, Sommers K, Belvis D, Shah RD, Sawardekar A, Eidem J, Dagraca J, Mukherji I. A randomized comparison of the laryngeal mask airway supreme and laryngeal mask airway unique in infants and children: does cuff pressure influence leak pressure? Paediatr Anaesth. 2013 Oct;23(10):927-33. doi: 10.1111/pan.12145. Epub 2013 Mar 23.
PubMed 23521105
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of the Ambu AuraGain™ and LMA Supreme™ in Infants and Children
- ClinicalTrials.gov ID
- NCT02380768
- Acronym / sponsor ID
- IRB 2015-252
- Conditions
- Supraglottic Airway
- Keywords
- Supraglottic airway, Laryngeal mask airway, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 5 Mar 2015 (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 purpose of this study is to determine whether there is a clinically relevant difference in airway leak pressures between the Ambu AuraGain and the Laryngeal Mask Airway (LMA) Supreme.
Detailed description
The goal of this prospective randomized study is to compare whether there is a clinically relevant difference in airway leak pressures between the Ambu AuraGain (sizes 1.5 and 2) and the Laryngeal Mask Airway (LMA) Supreme. Parameters of clinical relevance such as insertion success rates, fiberoptic view of the glottic opening, ease and speed of gastric tube placement, airway stability, and peri-operative complications will also be assessed.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambu AuraGain | Experimental | Device: Ambu AuraGain (size 1.5 or size 2.0)Subjects will receive the Ambu AuraGain size 1.5 or 2.0 based on manufacturer guidelines |
| LMA Supreme | Active comparator | Device: LMA Supreme (size 1.5 or size 2.0)Subjects will receive the Ambu AuraGain size 1.5 or 2.0 based on manufacturer guidelines |
Who may qualify
- Ages
- 3 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Scheduled for surgery utilizing a supraglottic airway device
- ASA (American Society of Anesthesiologists) I-III classification
- Weighing between 5 - 20 kilograms
Key exclusion criteria (7 listed)
- Active respiratory infection
- History of difficult mask ventilation
- Diagnosis of congenital syndrome with difficult airway management
- Active gastrointestinal reflux
- Coagulopathy
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 |
|---|---|---|
| Ambu AuraGain (size 1.5 or size 2.0)Also: Ambu AuraGainThe device will be inserted and timed. A leak pressure test will be performed after successful insertion and after 10 minutes. The larynx will be visualized by placing a fiberoptic bronchoscope through the device. A gastric tube will be inserted through the device and timed. | Device | Ambu AuraGain |
| LMA Supreme (size 1.5 or size 2.0)Also: LMA SupremeThe device will be inserted and timed. A leak pressure test will be performed after successful insertion and after 10 minutes. The larynx will be visualized by placing a fiberoptic bronchoscope through the device. A gastric tube will be inserted through the device and timed. | Device | LMA Supreme |
Primary outcome
Oropharyngeal (airway) leak pressure - Initial
Time frame: Assessed intraoperatively at the time of confirmed device placement
The airway pressure at which an airway leak is observed after successful placement of the supraglottic airway
Oropharyngeal (airway) leak pressure - 10 Minutes
Time frame: Assessed intraoperatively, 10 minutes after the initial confirmed placement of the device
The airway pressure at which an airway leak is observed 10 minutes after successful placement of the supraglottic airway
8 secondary outcomes
Time for Successful Placement of the Supraglottic Airway
Time frame: Assessed intraoperatively at the time of confirmed device placement
Number of attempts to placement of Supraglottic Airway
Time frame: Assessed intraoperatively at the time of confirmed device placement
Fiberoptic Grade of Laryngeal View through Supraglottic Airway
Time frame: Assessed intraoperatively at the time of confirmed device placement
Gastric Tube Insertion Ease of Placement
Time frame: Assessed intraoperatively at the time of confirmed gastric tube placement
Gastric Tube Insertion Time
Time frame: Assessed intraoperatively at the time of confirmed gastric tube placement
Gastric Tube Insertion Attempts
Time frame: Assessed intraoperatively at the time of confirmed gastric tube placement
Postoperative Complications
Time frame: Participants will be followed for the duration of hospital stay. Outcome measure will be assessed postoperatively in recovery unit.
Intraoperative Complications
Time frame: Assessed intraoperatively
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 20 Jul 2015.
- Background: PubMed 19572845White MC, Cook TM, Stoddart PA. A critique of elective pediatric supraglottic airway devices. Paediatr Anaesth. 2009 Jul;19 Suppl 1:55-65. doi: 10.1111/j.1460-9592.2009.02997.x.
- Background: PubMed 25585975Jagannathan N, Ramsey MA, White MC, Sohn L. An update on newer pediatric supraglottic airways with recommendations for clinical use. Paediatr Anaesth. 2015 Apr;25(4):334-45. doi: 10.1111/pan.12614. Epub 2015 Jan 13.
- 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 23521105Jagannathan N, Sohn L, Sommers K, Belvis D, Shah RD, Sawardekar A, Eidem J, Dagraca J, Mukherji I. A randomized comparison of the laryngeal mask airway supreme and laryngeal mask airway unique in infants and children: does cuff pressure influence leak pressure? Paediatr Anaesth. 2013 Oct;23(10):927-33. doi: 10.1111/pan.12145. Epub 2013 Mar 23.
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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, M.D. 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 Ambu AuraGain (size 1.5 or size 2.0) and LMA Supreme (size 1.5 or size 2.0) in people with Supraglottic Airway, 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 7 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 20 Jul 2015. 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?
Oropharyngeal (airway) leak pressure - Initial (time frame: Assessed intraoperatively at the time of confirmed device placement). The study lists 2 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 NCT02380768, which also lists 4 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 20 Jul 2015.