Tracheal IntubationNCT02029300
A Comparison of Nasal Versus Oral Fiberoptic Intubation in Children
A study testing Fiberoptic Intubation through the nasal route and Fiberoptic intubation through the oral route in people with Tracheal Intubation, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
There are two routes in which a fiberoptic intubation can be performed - oral and nasal. In general, nasal intubation by any conventional method may be the preferred choice for certain procedures such as intra-oral surgeries, or for anatomical reasons such as limited mouth opening. Read more about this study
- Who is it for?
- Ages 1 day to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Tracheal Intubation
- What is being tested?
- Fiberoptic Intubation through the nasal route and Fiberoptic intubation through the oral route
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Mar 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 day to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children ASA I to III
- Patients less than or equal to 2 years of age
- Patients with scheduled surgeries in which endotracheal intubation is part of their general anesthetic plan
Who cannot join
- Children with ASA IV or V
- Children with active respiratory infection, pulmonary disease, a known history of difficult mask ventilation, high suspicion of difficult airway (secondary to congenital syndromes for example), and significant airway abnormalities
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 Nasal Versus Oral Fiberoptic Intubation in Children Less Than Two Years of Age
There are two routes in which a fiberoptic intubation can be performed - oral and nasal. In general, nasal intubation by any conventional method may be the preferred choice for certain procedures such as intra-oral surgeries, or for anatomical reasons such as limited mouth opening. If nasal intubation is not indicated or preferred, then oral intubation is usually performed.
This study is looking to explore whether or not the nasal route significantly improves the ease and time for successful fiberoptic intubation compared to the oral route in children less than or equal to 2 years of age. This study will also examine if operator experience influence time to tracheal intubation with either route?
The investigators hypothesize that the nasal route of fiberoptic intubation will be faster than the oral route, for both the trainee and the expert, and that there will be minimal differences between experts and trainees with nasal fiberoptic intubation.
Read the detailed description
The goal of this prospective randomized study is to compare the effect of nasal fiberoptic intubation versus oral fiberoptic intubation in children less than 2 years of age. Other factors that will be assesed include operator experience, the ease and time for fiberoptic grade of laryngeal view, time for fiberoptic tracheal intubation, and complications.
This study is looking to explore whether or not the nasal route significantly improves the ease and time for successful fiberoptic intubation compared to the oral route in children less than or equal to 2 years of age. While also asking, will operator experience influence time to tracheal intubation with either route?
The investigators hypothesize that the nasal route fiberoptic intubation will be faster than the oral route, for both the trainee and the expert, and that there will be minimal differences between experts and trainees with nasal fiberoptic intubation.
- Conditions
- Tracheal Intubation
- Being tested
- Fiberoptic Intubation through the nasal route, Fiberoptic intubation through the oral route
- Keywords
- pediatrics, fiberoptic intubation, oral intubation, nasal intubation, children under the age of 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiberoptic Intubation through the nasal routeOther
Fiberoptic intubation through the oral routeOther
| Study group | Role | What they receive |
|---|---|---|
| Nasal Route | Other | The nasal route will be when the airway is acquired and secured with a fiberoptic bronchoscope through one of the nares. Receives: Other: Fiberoptic Intubation through the nasal route |
| Oral Route | Other | The oral route will be when the airway is acquired and secured with a fiberoptic bronchoscope through the patient's mouth. Receives: Other: Fiberoptic intubation through the oral route |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to fiberoptic intubation
Measured: From disconnection of oxygen to reconnection of oxygen during tracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tracheal IntubationStudies 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
- Primary purpose
- Treatment
- 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, MD, Principal investigator, Lurie Childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029300
- Sponsor's protocol ID
- 2014-15520
- Other IDs
- 2014
- Status last verified
- May 2014
- First submitted
- 7 Nov 2013
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Wheeler M, Roth AG, Dsida RM, Rae B, Seshadri R, Sullivan CL, Heffner CL, Cote CJ. Teaching residents pediatric fiberoptic intubation of the trachea: traditional fiberscope with an eyepiece versus a video-assisted technique using a fiberscope with an integrated camera. Anesthesiology. 2004 Oct;101(4):842-6. doi: 10.1097/00000542-200410000-00007.
PubMed 15448515Jagannathan N, Sequera-Ramos L, Sohn L, Huang A, Sawardekar A, Wasson N, Miriyala A, De Oliveira GS. Randomized comparison of experts and trainees with nasal and oral fibreoptic intubation in children less than 2 yr of age. Br J Anaesth. 2015 Feb;114(2):290-6. doi: 10.1093/bja/aeu370. Epub 2014 Nov 5.
PubMed 25377166
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Nasal Versus Oral Fiberoptic Intubation in Children Less Than Two Years of Age
- ClinicalTrials.gov ID
- NCT02029300
- Acronym / sponsor ID
- 2014-15520
- Conditions
- Tracheal Intubation
- Keywords
- pediatrics, fiberoptic intubation, oral intubation, nasal intubation, children under the age of 2
- 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
- Nov 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 7 Jan 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.
There are two routes in which a fiberoptic intubation can be performed - oral and nasal. In general, nasal intubation by any conventional method may be the preferred choice for certain procedures such as intra-oral surgeries, or for anatomical reasons such as limited mouth opening. If nasal intubation is not indicated or preferred, then oral intubation is usually performed.
This study is looking to explore whether or not the nasal route significantly improves the ease and time for successful fiberoptic intubation compared to the oral route in children less than or equal to 2 years of age. This study will also examine if operator experience influence time to tracheal intubation with either route?
The investigators hypothesize that the nasal route of fiberoptic intubation will be faster than the oral route, for both the trainee and the expert, and that there will be minimal differences between experts and trainees with nasal fiberoptic intubation.
Detailed description
The goal of this prospective randomized study is to compare the effect of nasal fiberoptic intubation versus oral fiberoptic intubation in children less than 2 years of age. Other factors that will be assesed include operator experience, the ease and time for fiberoptic grade of laryngeal view, time for fiberoptic tracheal intubation, and complications.
This study is looking to explore whether or not the nasal route significantly improves the ease and time for successful fiberoptic intubation compared to the oral route in children less than or equal to 2 years of age. While also asking, will operator experience influence time to tracheal intubation with either route?
The investigators hypothesize that the nasal route fiberoptic intubation will be faster than the oral route, for both the trainee and the expert, and that there will be minimal differences between experts and trainees with nasal fiberoptic intubation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal Route | Other | Other: Fiberoptic Intubation through the nasal routeThe nasal route will be when the airway is acquired and secured with a fiberoptic bronchoscope through one of the nares. |
| Oral Route | Other | Other: Fiberoptic intubation through the oral routeThe oral route will be when the airway is acquired and secured with a fiberoptic bronchoscope through the patient's mouth. |
Who may qualify
- Ages
- 1 day to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy children ASA I to III
- Patients less than or equal to 2 years of age
- Patients with scheduled surgeries in which endotracheal intubation is part of their general anesthetic plan
Key exclusion criteria (2 listed)
- Children with ASA IV or V
- Children with active respiratory infection, pulmonary disease, a known history of difficult mask ventilation, high suspicion of difficult airway (secondary to congenital syndromes for example), and significant airway abnormalities
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 |
|---|---|---|
| Fiberoptic Intubation through the nasal route | Other | Nasal Route |
| Fiberoptic intubation through the oral route | Other | Oral Route |
Primary outcome
Time to fiberoptic intubation
Time frame: From disconnection of oxygen to reconnection of oxygen during tracheal intubation
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 28 May 2014.
- Background: PubMed 15448515Wheeler M, Roth AG, Dsida RM, Rae B, Seshadri R, Sullivan CL, Heffner CL, Cote CJ. Teaching residents pediatric fiberoptic intubation of the trachea: traditional fiberscope with an eyepiece versus a video-assisted technique using a fiberscope with an integrated camera. Anesthesiology. 2004 Oct;101(4):842-6. doi: 10.1097/00000542-200410000-00007.
- Derived from this study: PubMed 25377166Jagannathan N, Sequera-Ramos L, Sohn L, Huang A, Sawardekar A, Wasson N, Miriyala A, De Oliveira GS. Randomized comparison of experts and trainees with nasal and oral fibreoptic intubation in children less than 2 yr of age. Br J Anaesth. 2015 Feb;114(2):290-6. doi: 10.1093/bja/aeu370. Epub 2014 Nov 5.
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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
Lurie Childrens Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fiberoptic Intubation through the nasal route and Fiberoptic intubation through the oral route in people with Tracheal Intubation, 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 2 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 28 May 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 fiberoptic intubation (time frame: From disconnection of oxygen to reconnection of oxygen during tracheal intubation). 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 NCT02029300, which also lists 2 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 28 May 2014.