Tracheal Intubation in ChildrenNCT02189590
Assessment of the I-gel and Air-Q Supraglottic Airways as Conduits for Tracheal Intubation in Children
A study testing i-gel and air-Q in people with Tracheal Intubation in Children, 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 if there is a difference in time for successful fiberoptic guided tracheal intubation through the i-gel or air-Q supraglottic airway. Read more about this study
- Who is it for?
- Ages 1 month to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Tracheal Intubation in Children
- What is being tested?
- i-gel and air-Q
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Sep 2014
- 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 1 month to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children undergoing general anesthesia requiring tracheal intubation
- Age one month to six years
Who cannot join
- ASA class IV, V
- Children receiving emergent surgery
- History or high suspicion of a difficult airway
- Active upper respiratory tract infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Anne & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
Official title: A Randomized Comparison of the I-gel and Air-Q as Conduits for Fiberoptic-guided Tracheal Intubation in Children
The purpose of this study is to determine if there is a difference in time for successful fiberoptic guided tracheal intubation through the i-gel or air-Q supraglottic airway.
Read the detailed description
The goal of this randomized study is to evaluate the efficacy of the i-gel as a conduit for fiberoptic tracheal intubation when compared to the air-Q in children. Intubations will be performed by residents in training. The primary outcome is of time for successful tracheal intubation. The investigators hypothesize that residents will intubate the trachea faster when using the air-Q as compared to the i-gel. The ease of placement of the supraglottic airway device, fiberoptic grade of laryngeal view, time for device removal after intubation, and peri-operative complications will also be assessed.
- Conditions
- Tracheal Intubation in Children
- Being tested
- i-gel, air-Q
- Keywords
- supraglottic airway, children, fiberoptic guided tracheal intubation, air-Q, i-gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-gelDevice
Patients randomized to this intervention will have the i-gel placed following induction of general anesthesia. Subsequent tracheal intubation will be performed using the device as a conduit for fiberoptic-guided intubation. Following successful tracheal intubation, the device will be removed.
air-QDevice
Patients randomized to this intervention will have the air-Q placed following induction of general anesthesia. Subsequent tracheal intubation will be performed using the device as a conduit for fiberoptic-guided intubation. Following successful tracheal intubation, the device will be removed.
| Study group | Role | What they receive |
|---|---|---|
| air-Q | Experimental | Patients will receive the air-Q with size based on manufacturer recommendations of body weight Receives: Device: air-Q |
| i-gel | Experimental | Patients will receive the i-gel with size based on manufacturer recommendations of body weight Receives: Device: i-gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Successful Tracheal Intubation
Time to successful tracheal intubation when using fiberoptic bronchoscopy to intubate through the i-gel or air-Q ILA. Three separate times will be measured by an independent observer: 1) Time to first glottic view: defined as the duration of time ending with the first view of the glottic opening. 2) Time to carinal view: defined as the duration of time ending with visualization of the carina. 3) Time to successful tracheal intubation: defined as the duration of time ending with the observation of a square wave end-tidal capnogram after successful tracheal intubation
Measured: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Secondary outcomes (8)
Ease of Placement of Supraglottic Airway
Ease of placement of supraglottic 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
Number of Attempts to Place the Supraglottic Device
Number of attempts will be limited to 3
Measured: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Supraglottic Airway Leak Pressure
The airway pressure at which an airway leak is observed after placement of the supraglottic airway
Measured: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Fiberoptic Grade of Laryngeal View
Fiberoptic Grade of Laryngeal View through either the air Q or i-gel will be graded using a previously published grading system
Measured: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Airway Maneuvers
The number and type of airway maneuvers performed during tracheal intubation 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 the airway, such as sore throat or hoarseness.
Measured: Participants will be followed for the duration of anesthesia and 24 hours postoperatively
Time to Placement of Supraglottic Airway
Time to placement of supraglottic device will be measured.
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 Tracheal Tube
Number of attempts to place the tracheal tube via fiberoptic bronchoscopy through supraglottic device will be limited to 3
Measured: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Tracheal Intubation 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 96 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 / Stanley Manne Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189590
- Sponsor's protocol ID
- I-gel versus air-Q
- Status last verified
- Oct 2014
- First submitted
- 9 Jul 2014
- Last updated
- 24 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Timmermann A. Supraglottic airways in difficult airway management: successes, failures, use and misuse. Anaesthesia. 2011 Dec;66 Suppl 2:45-56. doi: 10.1111/j.1365-2044.2011.06934.x.
PubMed 22074079Sohn LE, Jagannathan N, Sequera-Ramos L, Sawardekar A, Schaldenbrand K, De Oliveira GS. A randomised comparison of free-handed vs air-Q assisted fibreoptic-guided tracheal intubation in children < 2 years of age. Anaesthesia. 2014 Jul;69(7):723-8. doi: 10.1111/anae.12667. Epub 2014 May 2.
PubMed 24797607Mathis 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 24126262Abukawa Y, Hiroki K, Ozaki M. Initial experience of the i-gel supraglottic airway by the residents in pediatric patients. J Anesth. 2012 Jun;26(3):357-61. doi: 10.1007/s00540-011-1322-1. Epub 2012 Feb 7.
PubMed 22310833Foucher-Lezla A, Lehousse T, Monrigal JP, Granry JC, Beydon L. Fibreoptic assessment of laryngeal positioning of the paediatric supraglottic airway device I-Gel. Eur J Anaesthesiol. 2013 Jul;30(7):441-2. doi: 10.1097/EJA.0b013e32835f9969. No abstract available.
PubMed 23571478Hughes C, Place K, Berg S, Mason D. A clinical evaluation of the I-gel supraglottic airway device in children. Paediatr Anaesth. 2012 Aug;22(8):765-71. doi: 10.1111/j.1460-9592.2012.03893.x. Epub 2012 Jun 1.
PubMed 22672411Jagannathan N, Sommers K, Sohn LE, Sawardekar A, Shah RD, Mukherji II, Miller S, Voronov P, Seraphin S. A randomized equivalence trial comparing the i-gel and laryngeal mask airway Supreme in children. Paediatr Anaesth. 2013 Feb;23(2):127-33. doi: 10.1111/pan.12078. Epub 2012 Nov 27.
PubMed 23189931Emmerich M, Tiesmeier J. The I-gel supraglottic airway: a useful tool in case of difficult fiberoptic intubation. Minerva Anestesiol. 2012 Oct;78(10):1169-70. No abstract available.
PubMed 23059523Kim YL, Seo DM, Shim KS, Kim EJ, Lee JH, Lee SG, Ban JS. Successful tracheal intubation using fiberoptic bronchoscope via an I-gel supraglottic airway in a pediatric patient with Goldenhar syndrome -A case report-. Korean J Anesthesiol. 2013 Jul;65(1):61-5. doi: 10.4097/kjae.2013.65.1.61. Epub 2013 Jul 19.
PubMed 23904941Kim MS, Oh JT, Min JY, Lee KH, Lee JR. A randomised comparison of the i-gel and the Laryngeal Mask Airway Classic in infants. Anaesthesia. 2014 Apr;69(4):362-7. doi: 10.1111/anae.12592.
PubMed 24641642Jagannathan N, Sohn LE, Sawardekar A, Gordon J, Shah RD, Mukherji II, Roth AG, Suresh S. A randomized trial comparing the Ambu (R) Aura-i with the air-Q intubating laryngeal airway as conduits for tracheal intubation in children. Paediatr Anaesth. 2012 Dec;22(12):1197-204. doi: 10.1111/pan.12024. Epub 2012 Sep 13.
PubMed 22971118Park C, Bahk JH, Ahn WS, Do SH, Lee KH. The laryngeal mask airway in infants and children. Can J Anaesth. 2001 Apr;48(4):413-7. doi: 10.1007/BF03014975.
PubMed 11339788Jagannathan N, Sohn L, Ramsey M, Huang A, Sawardekar A, Sequera-Ramos L, Kromrey L, De Oliveira GS. A randomized comparison between the i-gel and the air-Q supraglottic airways when used by anesthesiology trainees as conduits for tracheal intubation in children. Can J Anaesth. 2015 Jun;62(6):587-94. doi: 10.1007/s12630-014-0304-9. Epub 2014 Dec 24.
PubMed 25537736
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of the I-gel and Air-Q as Conduits for Fiberoptic-guided Tracheal Intubation in Children
- ClinicalTrials.gov ID
- NCT02189590
- Acronym / sponsor ID
- I-gel versus air-Q
- Conditions
- Tracheal Intubation in Children
- Keywords
- supraglottic airway, children, fiberoptic guided tracheal intubation, air-Q, i-gel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 14 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.
The purpose of this study is to determine if there is a difference in time for successful fiberoptic guided tracheal intubation through the i-gel or air-Q supraglottic airway.
Detailed description
The goal of this randomized study is to evaluate the efficacy of the i-gel as a conduit for fiberoptic tracheal intubation when compared to the air-Q in children. Intubations will be performed by residents in training. The primary outcome is of time for successful tracheal intubation. The investigators hypothesize that residents will intubate the trachea faster when using the air-Q as compared to the i-gel. The ease of placement of the supraglottic airway device, fiberoptic grade of laryngeal view, time for device removal after intubation, and peri-operative complications will also be assessed.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| air-Q | Experimental | Device: air-QPatients will receive the air-Q with size based on manufacturer recommendations of body weight |
| i-gel | Experimental | Device: i-gelPatients will receive the i-gel with size based on manufacturer recommendations of body weight |
Who may qualify
- Ages
- 1 month to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children undergoing general anesthesia requiring tracheal intubation
- Age one month to six years
Key exclusion criteria (4 listed)
- ASA class IV, V
- Children receiving emergent surgery
- History or high suspicion of a difficult airway
- 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 |
|---|---|---|
| i-gelPatients randomized to this intervention will have the i-gel placed following induction of general anesthesia. Subsequent tracheal intubation will be performed using the device as a conduit for fiberoptic-guided intubation. Following successful tracheal intubation, the device will be removed. | Device | i-gel |
| air-QPatients randomized to this intervention will have the air-Q placed following induction of general anesthesia. Subsequent tracheal intubation will be performed using the device as a conduit for fiberoptic-guided intubation. Following successful tracheal intubation, the device will be removed. | Device | air-Q |
Primary outcome
Time to Successful Tracheal Intubation
Time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Time to successful tracheal intubation when using fiberoptic bronchoscopy to intubate through the i-gel or air-Q ILA. Three separate times will be measured by an independent observer: 1) Time to first glottic view: defined as the duration of time ending with the first view of the glottic opening. 2) Time to carinal view: defined as the duration of time ending with visualization of the carina. 3) Time to successful tracheal intubation: defined as the duration of time ending with the observation of a square wave end-tidal capnogram after successful tracheal intubation
8 secondary outcomes
Ease of Placement of Supraglottic 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 Supraglottic Device
Time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Supraglottic Airway Leak Pressure
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
Airway Maneuvers
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
Time to Placement of Supraglottic 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 Tracheal Tube
Time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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 24 Oct 2014.
- Background: PubMed 22074079Timmermann A. Supraglottic airways in difficult airway management: successes, failures, use and misuse. Anaesthesia. 2011 Dec;66 Suppl 2:45-56. doi: 10.1111/j.1365-2044.2011.06934.x.
- Background: PubMed 24797607Sohn LE, Jagannathan N, Sequera-Ramos L, Sawardekar A, Schaldenbrand K, De Oliveira GS. A randomised comparison of free-handed vs air-Q assisted fibreoptic-guided tracheal intubation in children < 2 years of age. Anaesthesia. 2014 Jul;69(7):723-8. doi: 10.1111/anae.12667. Epub 2014 May 2.
- 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.
- Background: PubMed 22310833Abukawa Y, Hiroki K, Ozaki M. Initial experience of the i-gel supraglottic airway by the residents in pediatric patients. J Anesth. 2012 Jun;26(3):357-61. doi: 10.1007/s00540-011-1322-1. Epub 2012 Feb 7.
- Background: PubMed 23571478Foucher-Lezla A, Lehousse T, Monrigal JP, Granry JC, Beydon L. Fibreoptic assessment of laryngeal positioning of the paediatric supraglottic airway device I-Gel. Eur J Anaesthesiol. 2013 Jul;30(7):441-2. doi: 10.1097/EJA.0b013e32835f9969. No abstract available.
- Background: PubMed 22672411Hughes C, Place K, Berg S, Mason D. A clinical evaluation of the I-gel supraglottic airway device in children. Paediatr Anaesth. 2012 Aug;22(8):765-71. doi: 10.1111/j.1460-9592.2012.03893.x. Epub 2012 Jun 1.
- Background: PubMed 23189931Jagannathan N, Sommers K, Sohn LE, Sawardekar A, Shah RD, Mukherji II, Miller S, Voronov P, Seraphin S. A randomized equivalence trial comparing the i-gel and laryngeal mask airway Supreme in children. Paediatr Anaesth. 2013 Feb;23(2):127-33. doi: 10.1111/pan.12078. Epub 2012 Nov 27.
- Background: PubMed 23059523Emmerich M, Tiesmeier J. The I-gel supraglottic airway: a useful tool in case of difficult fiberoptic intubation. Minerva Anestesiol. 2012 Oct;78(10):1169-70. No abstract available.
- Background: PubMed 23904941Kim YL, Seo DM, Shim KS, Kim EJ, Lee JH, Lee SG, Ban JS. Successful tracheal intubation using fiberoptic bronchoscope via an I-gel supraglottic airway in a pediatric patient with Goldenhar syndrome -A case report-. Korean J Anesthesiol. 2013 Jul;65(1):61-5. doi: 10.4097/kjae.2013.65.1.61. Epub 2013 Jul 19.
- Background: PubMed 24641642Kim MS, Oh JT, Min JY, Lee KH, Lee JR. A randomised comparison of the i-gel and the Laryngeal Mask Airway Classic in infants. Anaesthesia. 2014 Apr;69(4):362-7. doi: 10.1111/anae.12592.
- Background: PubMed 22971118Jagannathan N, Sohn LE, Sawardekar A, Gordon J, Shah RD, Mukherji II, Roth AG, Suresh S. A randomized trial comparing the Ambu (R) Aura-i with the air-Q intubating laryngeal airway as conduits for tracheal intubation in children. Paediatr Anaesth. 2012 Dec;22(12):1197-204. doi: 10.1111/pan.12024. Epub 2012 Sep 13.
- Background: PubMed 11339788Park C, Bahk JH, Ahn WS, Do SH, Lee KH. The laryngeal mask airway in infants and children. Can J Anaesth. 2001 Apr;48(4):413-7. doi: 10.1007/BF03014975.
Related trials for Tracheal Intubation in Children
Not yet recruitingObservational study
AI-assisted Tracheal Intubation in Children
Intubation
RecruitingObservational study
CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation
Intubation Complication, Adverse Events
Recruiting
MAsk VEntilation With Paratracheal Pressure In Children. Para Tracheal Compression to Prevent Gastric Insufflation in Children
Surgery, Anesthesia Intubation Complication
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?
A study testing i-gel and air-Q in people with Tracheal Intubation 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 2 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 24 Oct 2014. 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?
Time to Successful Tracheal Intubation (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 NCT02189590, which also lists 13 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 24 Oct 2014.