ChildrenNCT01449656
A Comparison of the Laryngeal Mask Airway (LMA) Proseal and LMA Supreme in Children
An observational study of 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 laryngeal mask airways with a provision for evacuation of gastric contents, the LMA Proseal and The investigators hypothesize that airway leak pressures with the LMA Proseal will be significantly different (higher) when compared with the LMA Supreme. Read more about this study
- Who is it for?
- Ages 6 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Children
- What is being tested?
- LMA Supreme: comparison device
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Nov 2011
- 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 6 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children weighing 10 to 20 kg undergoing surgical or medical procedures under anesthesia requiring a supraglottic airway device
Who may be able to join
- Children undergoing general anesthesia using a supraglottic airway device
- weight 10-20 kg
- age 6 months-6 years
Who cannot join
- ASA class IV, V Emergency procedures
- History of a difficult airway
- Active gastrointestinal reflux
- Active upper respiratory tract infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Childrens Memorial Hospital
Chicago, Illinois, 60614
About this study
Official title: A Randomized Trial Comparing the Laryngeal Mask Airway-SupremeTM With the Laryngeal Mask Airway-ProsealTM in Children
The aim of this randomized prospective study is to compare two laryngeal mask airways with a provision for evacuation of gastric contents, the LMA Proseal and The investigators hypothesize that airway leak pressures with the LMA Proseal will be significantly different (higher) when compared with the LMA Supreme.
Read the detailed description
The goal of this study is to compare the LMA Proseal and LMA Supreme in children having surgery. The investigators hypothesize that the airway leak pressures with the LMA Proseal will be superior to the LMA Supreme. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. The ease of placement of the device and gastric tube, fiberoptic grade of laryngeal view, feasibility of use during positive pressure ventilation, and complications (airway related, gastric insufflation, trauma) will also be assessed.
- Conditions
- Children
- Being tested
- LMA Proseal: 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 Proseal: control deviceDevice
Also called laryngeal mask airway
LMA Proseal will be placed in children weighing 10-20kg based on a computer generated randomization
LMA Supreme: comparison deviceDevice
Also called laryngeal mask airway
LMA Supreme will be placed in children weighing 10-20kg based on a computer generated randomization
| Study group | Role | What they receive |
|---|---|---|
| LMA proseal | Not described Receives: Device: LMA Proseal: control device | |
| LMA Supreme | 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 completely.
Measured: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Secondary outcomes (9)
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
Fiberoptic view through the gastric tube
The view through the gastric drain tube of the LMA supreme will be assessed and 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
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
Adverse effects
complications such as oxygen desaturations, mucosal trauma, reflex activation of the airway, sore throat, dysphonia will be recorded
Measured: Participants will be followed for the duration of anesthesia and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 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, Childrens Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449656
- Sponsor's protocol ID
- PLMA vs SLMA
- Status last verified
- Dec 2011
- First submitted
- 4 Oct 2011
- Last updated
- 12 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Trevisanuto D, Parotto M, Doglioni N, Ori C, Zanardo V, Micaglio M. The Supreme Laryngeal Mask Airway (LMA): a new neonatal supraglottic device: comparison with Classic and ProSeal LMA in a manikin. Resuscitation. 2012 Jan;83(1):97-100. doi: 10.1016/j.resuscitation.2011.07.032. Epub 2011 Aug 11.
PubMed 21839703Seet E, Rajeev S, Firoz T, Yousaf F, Wong J, Wong DT, Chung F. Safety and efficacy of laryngeal mask airway Supreme versus laryngeal mask airway ProSeal: a randomized controlled trial. Eur J Anaesthesiol. 2010 Jul;27(7):602-7. doi: 10.1097/eja.0b013e32833679e3.
PubMed 20540172White 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 19572845
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2011. 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 Laryngeal Mask Airway-ProsealTM in Children
- ClinicalTrials.gov ID
- NCT01449656
- Acronym / sponsor ID
- PLMA vs SLMA
- Conditions
- Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 10 Oct 2011 (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 laryngeal mask airways with a provision for evacuation of gastric contents, the LMA Proseal and The investigators hypothesize that airway leak pressures with the LMA Proseal will be significantly different (higher) when compared with the LMA Supreme.
Detailed description
The goal of this study is to compare the LMA Proseal and LMA Supreme in children having surgery. The investigators hypothesize that the airway leak pressures with the LMA Proseal will be superior to the LMA Supreme. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. The ease of placement of the device and gastric tube, fiberoptic grade of laryngeal view, feasibility of use during positive pressure ventilation, and complications (airway related, gastric insufflation, trauma) will also be assessed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LMA proseal | – | Device: LMA Proseal: control device |
| LMA Supreme | – | Device: LMA Supreme: comparison device |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children weighing 10 to 20 kg undergoing surgical or medical procedures under anesthesia requiring a supraglottic airway device
Key inclusion criteria (3 listed)
- Children undergoing general anesthesia using a supraglottic airway device
- weight 10-20 kg
- age 6 months-6 years
Key exclusion criteria (4 listed)
- ASA class IV, V Emergency procedures
- History of a difficult airway
- Active gastrointestinal reflux
- Active upper respiratory tract infection
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 Proseal: control deviceAlso: laryngeal mask airwayLMA Proseal will be placed in children weighing 10-20kg based on a computer generated randomization | Device | LMA proseal |
| LMA Supreme: comparison deviceAlso: laryngeal mask airwayLMA Supreme will be placed in children weighing 10-20kg based on a computer generated randomization | 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 completely.
9 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
Fiberoptic view through the gastric tube
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
Adverse effects
Time frame: Participants will be followed for the duration of anesthesia and 24 hours postoperatively
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 12 Dec 2011.
- Background: PubMed 21839703Trevisanuto D, Parotto M, Doglioni N, Ori C, Zanardo V, Micaglio M. The Supreme Laryngeal Mask Airway (LMA): a new neonatal supraglottic device: comparison with Classic and ProSeal LMA in a manikin. Resuscitation. 2012 Jan;83(1):97-100. doi: 10.1016/j.resuscitation.2011.07.032. Epub 2011 Aug 11.
- Background: PubMed 20540172Seet E, Rajeev S, Firoz T, Yousaf F, Wong J, Wong DT, Chung F. Safety and efficacy of laryngeal mask airway Supreme versus laryngeal mask airway ProSeal: a randomized controlled trial. Eur J Anaesthesiol. 2010 Jul;27(7):602-7. doi: 10.1097/eja.0b013e32833679e3.
- 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.
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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
Childrens Memorial Hospital
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 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 4 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 12 Dec 2011. 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 NCT01449656, which also lists 3 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 12 Dec 2011.