Supraglottic Airway Use in ChildrenNCT02202174
The Safety and Efficacy of Supraglottic Airway Use in Children
An observational study of Supraglottic Airway Use in Children, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
This purpose of this study is to determine the effectiveness, risk factors, and complications associated with use of supraglottic airway devices for primary airway maintenance during routine anesthesia in children. Read more about this study
- Who is it for?
- Ages 1 day to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Supraglottic Airway Use in Children
- What is being tested?
- Supraglottic Airway Device
- Type of treatment
- Medical device
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Oct 2015
- 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 day to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Pediatric patients undergoing anesthesia with use of a supraglottic airway device as primary means of oxygenation and ventilation.
Who may be able to join
- Children undergoing anesthesia with use of a supraglottic airway device as a primary means of oxygenation \& ventilation
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Narasimhan Jagannathan, MD, simjag2000@yahoo.com
Narasimhan Jagannathan, MD
About this study
This purpose of this study is to determine the effectiveness, risk factors, and complications associated with use of supraglottic airway devices for primary airway maintenance during routine anesthesia in children.
Read the detailed description
This study aims to understand the efficacy of supraglottic airway (SGA) use in children in a tertiary care Children's Hospital.
Observational data regarding the type of SGA, experience level of practitioner, placement technique, number of placement attempts or placement failure, device failure, and cause of any related peri-operative complications will be prospectively collected.
The data collected in this study will allow the investigators to assess the overall safety and efficacy of SGA use in various medical and surgical procedures performed under general anesthesia in children.
- Conditions
- Supraglottic Airway Use in Children
- Being tested
- Supraglottic Airway Device
- Keywords
- supraglottic airway, children, safety, efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supraglottic Airway DeviceDevice
Also called LMA Unique, LMA ProSeal, LMA Supreme, LMA Flexible
| Study group | Role | What they receive |
|---|---|---|
| Supraglottic Airway Device | Patients will receive a supraglottic airway device as a primary means of ventilation. The following devices may be used: LMA Unique, LMA ProSeal, LMA Supreme, LMA Flexible, Ambu Aura-I, Ambu Aura Once, Air-Q, I-Gel, or other supraglottic airway device. Choice of the device will be clinician dependent and based on the patients body weight per manufacturer guidelines Receives: Device: Supraglottic Airway Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Supraglottic Airway Device Failure
Occurrence and reason for supraglottic airway device failure (ie inadequate ventilation, laryngospasm, bronchospasm, etc) will be recorded in addition to conversion to tracheal intubation
Measured: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Secondary outcomes (6)
Ease of Placement of Supraglottic Airway Device
Ease of placement of supraglottic airway device ranging from 1 (easy) to 4 (difficult)
Measured: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Multiple Attempts to Place Supraglottic Airway Device
change in device, placement method, and provider will be recorded
Measured: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Airway Maneuvers/interventions
the number and type of airway maneuvers performed after device placement and during maintenance will be recorded
Measured: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Occurrence of Inadequate Ventilation
cause and solution for inadequate ventilation will be recorded
Measured: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Intraoperative Complications
Time period of complication (ie during device placement, maintenance, or removal) and cause of complication (ie. dental injury, light anesthesia, regurgitation, laryngospasm, bronchospasm, aspiration, etc.) will be recorded
Measured: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Postoperative Complications
Complications noted postoperatively relating to reflex activation of the airway, sore throat, or hoarseness
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 posted28 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
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 Supraglottic Airway Use 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
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 / Stanley Manne Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202174
- Sponsor's protocol ID
- 2014-15832
- Other IDs
- 2014
- Status last verified
- Jul 2015
- First submitted
- 25 Jul 2014
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Jagannathan N, Sequera-Ramos L, Sohn L, Wallis B, Shertzer A, Schaldenbrand K. Elective use of supraglottic airway devices for primary airway management in children with difficult airways. Br J Anaesth. 2014 Apr;112(4):742-8. doi: 10.1093/bja/aet411. Epub 2013 Dec 8.
PubMed 24322570Asai T. Is it safe to use supraglottic airway in children with difficult airways? Br J Anaesth. 2014 Apr;112(4):620-2. doi: 10.1093/bja/aeu005. Epub 2014 Feb 20. No abstract available.
PubMed 24561643Lopez-Gil M, Brimacombe J, Alvarez M. Safety and efficacy of the laryngeal mask airway. A prospective survey of 1400 children. Anaesthesia. 1996 Oct;51(10):969-72. doi: 10.1111/j.1365-2044.1996.tb14968.x.
PubMed 8984875Bordet F, Allaouchiche B, Lansiaux S, Combet S, Pouyau A, Taylor P, Bonnard C, Chassard D. Risk factors for airway complications during general anaesthesia in paediatric patients. Paediatr Anaesth. 2002 Nov;12(9):762-9. doi: 10.1046/j.1460-9592.2002.00987.x.
PubMed 12519134Lalwani K, Richins S, Aliason I, Milczuk H, Fu R. The laryngeal mask airway for pediatric adenotonsillectomy: predictors of failure and complications. Int J Pediatr Otorhinolaryngol. 2013 Jan;77(1):25-8. doi: 10.1016/j.ijporl.2012.09.021. Epub 2012 Oct 11.
PubMed 23063385Mathis MR, Haydar B, Taylor EL, Morris M, Malviya SV, Christensen RE, Ramachandran SK, Kheterpal S. Failure of the Laryngeal Mask Airway Unique and Classic in the pediatric surgical patient: a study of clinical predictors and outcomes. Anesthesiology. 2013 Dec;119(6):1284-95. doi: 10.1097/ALN.0000000000000015.
PubMed 24126262
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Supraglottic Airway Use in Children
- ClinicalTrials.gov ID
- NCT02202174
- Acronym / sponsor ID
- 2014-15832
- Conditions
- Supraglottic Airway Use in Children
- Keywords
- supraglottic airway, children, safety, efficacy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 28 Jul 2014 (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.
This purpose of this study is to determine the effectiveness, risk factors, and complications associated with use of supraglottic airway devices for primary airway maintenance during routine anesthesia in children.
Detailed description
This study aims to understand the efficacy of supraglottic airway (SGA) use in children in a tertiary care Children's Hospital.
Observational data regarding the type of SGA, experience level of practitioner, placement technique, number of placement attempts or placement failure, device failure, and cause of any related peri-operative complications will be prospectively collected.
The data collected in this study will allow the investigators to assess the overall safety and efficacy of SGA use in various medical and surgical procedures performed under general anesthesia in children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supraglottic Airway Device | – | Device: Supraglottic Airway DevicePatients will receive a supraglottic airway device as a primary means of ventilation. The following devices may be used: LMA Unique, LMA ProSeal, LMA Supreme, LMA Flexible, Ambu Aura-I, Ambu Aura Once, Air-Q, I-Gel, or other supraglottic airway device. Choice of the device will be clinician dependent and based on the patients body weight per manufacturer guidelines |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients undergoing anesthesia with use of a supraglottic airway device as primary means of oxygenation and ventilation.
Key inclusion criteria (1 listed)
- Children undergoing anesthesia with use of a supraglottic airway device as a primary means of oxygenation \& ventilation
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Supraglottic Airway DeviceAlso: LMA Unique, LMA ProSeal, LMA Supreme, LMA Flexible | Device | Supraglottic Airway Device |
Primary outcome
Supraglottic Airway Device Failure
Time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Occurrence and reason for supraglottic airway device failure (ie inadequate ventilation, laryngospasm, bronchospasm, etc) will be recorded in addition to conversion to tracheal intubation
6 secondary outcomes
Ease of Placement of Supraglottic Airway Device
Time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Multiple Attempts to Place Supraglottic Airway Device
Time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Airway Maneuvers/interventions
Time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Occurrence of Inadequate Ventilation
Time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Intraoperative Complications
Time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Postoperative Complications
Time frame: participants will be followed for the duration of anesthesia and 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
- Background: PubMed 24322570Jagannathan N, Sequera-Ramos L, Sohn L, Wallis B, Shertzer A, Schaldenbrand K. Elective use of supraglottic airway devices for primary airway management in children with difficult airways. Br J Anaesth. 2014 Apr;112(4):742-8. doi: 10.1093/bja/aet411. Epub 2013 Dec 8.
- Background: PubMed 24561643Asai T. Is it safe to use supraglottic airway in children with difficult airways? Br J Anaesth. 2014 Apr;112(4):620-2. doi: 10.1093/bja/aeu005. Epub 2014 Feb 20. No abstract available.
- Background: PubMed 8984875Lopez-Gil M, Brimacombe J, Alvarez M. Safety and efficacy of the laryngeal mask airway. A prospective survey of 1400 children. Anaesthesia. 1996 Oct;51(10):969-72. doi: 10.1111/j.1365-2044.1996.tb14968.x.
- Background: PubMed 12519134Bordet F, Allaouchiche B, Lansiaux S, Combet S, Pouyau A, Taylor P, Bonnard C, Chassard D. Risk factors for airway complications during general anaesthesia in paediatric patients. Paediatr Anaesth. 2002 Nov;12(9):762-9. doi: 10.1046/j.1460-9592.2002.00987.x.
- Background: PubMed 23063385Lalwani K, Richins S, Aliason I, Milczuk H, Fu R. The laryngeal mask airway for pediatric adenotonsillectomy: predictors of failure and complications. Int J Pediatr Otorhinolaryngol. 2013 Jan;77(1):25-8. doi: 10.1016/j.ijporl.2012.09.021. Epub 2012 Oct 11.
- Background: PubMed 24126262Mathis MR, Haydar B, Taylor EL, Morris M, Malviya SV, Christensen RE, Ramachandran SK, Kheterpal S. Failure of the Laryngeal Mask Airway Unique and Classic in the pediatric surgical patient: a study of clinical predictors and outcomes. Anesthesiology. 2013 Dec;119(6):1284-95. doi: 10.1097/ALN.0000000000000015.
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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 / Stanley Manne Research Institute
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 Supraglottic Airway Use 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 1 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: status not confirmed, as of the sponsor's last update on 29 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Narasimhan Jagannathan, MD (3122275170, njagannathan@luriechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Supraglottic Airway Device Failure (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 NCT02202174, 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 29 Jul 2015.