Fiberoptic Intubation in ChildrenNCT01876940
Comparison of Fiberoptic Intubation With Fiberoptic Intubation Through an Air-Q Intubating Laryngeal Airway in Infants and Small Children
A study testing air-Q, followed by fiberoptic intubation and Free-hand Fiberoptic Intubation in people with Fiberoptic Intubation in Children, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
The goal of this prospective randomized study is to compare the effect of operator experience on the ability to use fiberoptic-guided intubation in children less than two years old, with and without the use of an air-Q as a conduit. Read more about this study
- Who is it for?
- Ages 1 day to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Fiberoptic Intubation in Children
- What is being tested?
- air-Q, followed by fiberoptic intubation and Free-hand Fiberoptic Intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jul 2013
- 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 day to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy (ASA I to III) children who will be intubated as part of their general anesthesia plan for their scheduled surgeries
- Age 1 month - 2 years
- Weight 1-20 Kg
Who cannot join
- Children with active respiratory infection
- Known history of difficult mask ventilation
- Diagnosis of a congenital syndrome associated with difficult airway management
- Airway abnormalities (e.g., laryngomalacia, subglottic stenosis).
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 Free-handed Fiberoptic Intubation Compared With Fiberoptic Intubation Through an Air-QTM Intubating Laryngeal Airway in Children Less Than Two Years of Age: Does Operator Experience Affect Time to Successful Tracheal Intubation?
The goal of this prospective randomized study is to compare the effect of operator experience on the ability to use fiberoptic-guided intubation in children less than two years old, with and without the use of an air-Q as a conduit. The question the investigators are trying to answer is: Does the operator experience make a significant difference in the time for successful fiberoptic guided tracheal intubation with and without the use of an air-Q intubating laryngeal airway?
Read the detailed description
The aim of this study is to compare the effect of operator experience on the ability to use fiberoptic-guided intubation in children less than two years old, with and without the use of an air-Q as a conduit. The ease and time for placement of the air-Q, fiberoptic grade of laryngeal view, time for fiberoptic tracheal intubation, and peri-operative complications will also be assessed.
- Conditions
- Fiberoptic Intubation in Children
- Being tested
- air-Q, followed by fiberoptic intubation, Free-hand Fiberoptic Intubation
- Keywords
- supraglottic airway, children, tracheal intubation, fiberoptic bronchoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
air-Q, followed by fiberoptic intubationDevice
Also called Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed
Free-hand Fiberoptic IntubationDevice
Fiberoptic tracheal intubation will be performed without use of the air-Q and timed. Laryngeal grade of view will also be assessed
| Study group | Role | What they receive |
|---|---|---|
| Fiberoptic Intubation performed by an expert | Active comparator | Tracheal intubation will be performed by an expert anesthesia attending with and without use of the air-Q Receives: Device: air-Q, followed by fiberoptic intubation; Device: Free-hand Fiberoptic Intubation |
| Fiberoptic Intubation performed by a novice | Experimental | Tracheal intubation will be performed by an anesthesia trainee with and without use of the air-Q Receives: Device: air-Q, followed by fiberoptic intubation; Device: Free-hand Fiberoptic Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for successful fiberoptic tracheal intubation
The time for successful intubation will be from removal of the face mask or disconnection of the circuit from the air-Q until evidence of end-tidal CO2 is confirmed.
Measured: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Secondary outcomes (7)
Time to successful placement of the Air-Q
Successful placement of the air-Q will start with the removal of the facemask until presence of end-tidal CO2 is confirmed.
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 Air-Q
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
Ease for placement of the air-Q
The ease for Air-Q placement will be 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 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
Peri-operative complications
Includes: Complications during the placement of the Air-Q (Laryngospasm, Bronchospasm, Desaturation, etc. Oropharyngolaryngeal morbidity at discharge, participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours. Oropharyngolaryngeal morbidity at 24 hours post-operatively, measured at 24 hours after device placement/study initiation. These will be 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
Number of attempts for fiberoptic tracheal intubation
Number of attempts needed for successful fiberoptic tracheal intubation 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
Ease for fiberoptic tracheal intubation
The ease for fiberoptic tracheal intubation will be assessed using a subjective scale
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 posted13 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2013
- Study completionJul 2013
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 Fiberoptic 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
- None (open label)
- Enrolment
- 80 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 ChicagoLisa Sohn, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876940
- Sponsor's protocol ID
- IRB#2013-15391
- Status last verified
- Jul 2013
- First submitted
- 11 Jun 2013
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hodzovic I, Janakiraman C, Sudhir G, Goodwin N, Wilkes AR, Latto IP. Fibreoptic intubation through the laryngeal mask airway: effect of operator experience*. Anaesthesia. 2009 Oct;64(10):1066-71. doi: 10.1111/j.1365-2044.2009.06030.x.
PubMed 19735396Hodzovic I, Petterson J, Wilkes AR, Latto IP. Fibreoptic intubation using three airway conduits in a manikin: the effect of operator experience. Anaesthesia. 2007 Jun;62(6):591-7. doi: 10.1111/j.1365-2044.2007.05054.x.
PubMed 17506738Erb T, Marsch SC, Hampl KF, Frei FJ. Teaching the use of fiberoptic intubation for children older than two years of age. Anesth Analg. 1997 Nov;85(5):1037-41. doi: 10.1097/00000539-199711000-00013.
PubMed 9356095Jagannathan N, Kozlowski RJ, Sohn LE, Langen KE, Roth AG, Mukherji II, Kho MF, Suresh S. A clinical evaluation of the intubating laryngeal airway as a conduit for tracheal intubation in children. Anesth Analg. 2011 Jan;112(1):176-82. doi: 10.1213/ANE.0b013e3181fe0408. Epub 2010 Nov 16.
PubMed 21081777
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Free-handed Fiberoptic Intubation Compared With Fiberoptic Intubation Through an Air-QTM Intubating Laryngeal Airway in Children Less Than Two Years of Age: Does Operator Experience Affect Time to Successful Tracheal Intubation?
- ClinicalTrials.gov ID
- NCT01876940
- Acronym / sponsor ID
- IRB#2013-15391
- Conditions
- Fiberoptic Intubation in Children
- Keywords
- supraglottic airway, children, tracheal intubation, fiberoptic bronchoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 13 Jun 2013 (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 goal of this prospective randomized study is to compare the effect of operator experience on the ability to use fiberoptic-guided intubation in children less than two years old, with and without the use of an air-Q as a conduit. The question the investigators are trying to answer is: Does the operator experience make a significant difference in the time for successful fiberoptic guided tracheal intubation with and without the use of an air-Q intubating laryngeal airway?
Detailed description
The aim of this study is to compare the effect of operator experience on the ability to use fiberoptic-guided intubation in children less than two years old, with and without the use of an air-Q as a conduit. The ease and time for placement of the air-Q, fiberoptic grade of laryngeal view, time for fiberoptic tracheal intubation, 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 |
|---|---|---|
| Fiberoptic Intubation performed by an expert | Active comparator | Device: air-Q, followed by fiberoptic intubation, Device: Free-hand Fiberoptic IntubationTracheal intubation will be performed by an expert anesthesia attending with and without use of the air-Q |
| Fiberoptic Intubation performed by a novice | Experimental | Device: air-Q, followed by fiberoptic intubation, Device: Free-hand Fiberoptic IntubationTracheal intubation will be performed by an anesthesia trainee with and without use of the air-Q |
Who may qualify
- Ages
- 1 day to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy (ASA I to III) children who will be intubated as part of their general anesthesia plan for their scheduled surgeries
- Age 1 month - 2 years
- Weight 1-20 Kg
Key exclusion criteria (4 listed)
- Children with active respiratory infection
- Known history of difficult mask ventilation
- 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 |
|---|---|---|
| air-Q, followed by fiberoptic intubationAlso: Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed | Device | Fiberoptic Intubation performed by a novice, Fiberoptic Intubation performed by an expert |
| Free-hand Fiberoptic IntubationFiberoptic tracheal intubation will be performed without use of the air-Q and timed. Laryngeal grade of view will also be assessed | Device | Fiberoptic Intubation performed by a novice, Fiberoptic Intubation performed by an expert |
Primary outcome
Time for successful fiberoptic tracheal intubation
Time frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
The time for successful intubation will be from removal of the face mask or disconnection of the circuit from the air-Q until evidence of end-tidal CO2 is confirmed.
7 secondary outcomes
Time to successful placement of the Air-Q
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 Air-Q
Time frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Ease for placement of the air-Q
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
Peri-operative complications
Time frame: Measured at 24 hours after device placement/study initiation
Number of attempts for fiberoptic tracheal intubation
Time frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Ease for fiberoptic tracheal intubation
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 30 Jul 2013.
- Background: PubMed 19735396Hodzovic I, Janakiraman C, Sudhir G, Goodwin N, Wilkes AR, Latto IP. Fibreoptic intubation through the laryngeal mask airway: effect of operator experience*. Anaesthesia. 2009 Oct;64(10):1066-71. doi: 10.1111/j.1365-2044.2009.06030.x.
- Background: PubMed 17506738Hodzovic I, Petterson J, Wilkes AR, Latto IP. Fibreoptic intubation using three airway conduits in a manikin: the effect of operator experience. Anaesthesia. 2007 Jun;62(6):591-7. doi: 10.1111/j.1365-2044.2007.05054.x.
- Background: PubMed 9356095Erb T, Marsch SC, Hampl KF, Frei FJ. Teaching the use of fiberoptic intubation for children older than two years of age. Anesth Analg. 1997 Nov;85(5):1037-41. doi: 10.1097/00000539-199711000-00013.
- Background: PubMed 21081777Jagannathan N, Kozlowski RJ, Sohn LE, Langen KE, Roth AG, Mukherji II, Kho MF, Suresh S. A clinical evaluation of the intubating laryngeal airway as a conduit for tracheal intubation in children. Anesth Analg. 2011 Jan;112(1):176-82. doi: 10.1213/ANE.0b013e3181fe0408. Epub 2010 Nov 16.
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
Lisa Sohn, 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 air-Q, followed by fiberoptic intubation and Free-hand Fiberoptic Intubation in people with Fiberoptic 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 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 30 Jul 2013. 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 for successful fiberoptic 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 NCT01876940, 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 30 Jul 2013.