Nasotracheal IntubationNCT03003455
Nasotracheal Intubation Over a Bougie
A study testing Nasotracheal intubation over a bougie and Conventional Nasotracheal Intubation in people with Nasotracheal Intubation and Nasal Bleeding, run by University of Iowa at 1 site in United States.
Trial summary
The purpose of this study is to determine whether nasal intubation over a bougie placed via a nasal trumpet will decrease nasal trauma when compared to the conventional technique of blind nasal endotracheal tube passage. Read more about this study
- Who is it for?
- Ages 8 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasotracheal Intubation, Nasal Bleeding
- What is being tested?
- Nasotracheal intubation over a bougie and Conventional Nasotracheal Intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Feb 2016
- 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 8 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients scheduled for elective surgery with an anesthetic plan including asleep nasotracheal intubation
Who cannot join
- Patients needing emergent airway protection
- Patients undergoing emergency surgery
- Patients whom are known to be pregnant
- Patients whom are currently anticoagulated (including daily aspirin use)
- Patients whose anesthetic includes the use of nitrous oxide
- Patients whom are currently incarcerated
Show all 9Show fewer
- Patients 7 years of age or younger
- Mentally incompetent adults
- Patients whom refuse involvement in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
Official title: Nasotracheal Intubation Over a Bougie Placed Via a Subsequently Removed Nasal Trumpet
The purpose of this study is to determine whether nasal intubation over a bougie placed via a nasal trumpet will decrease nasal trauma when compared to the conventional technique of blind nasal endotracheal tube passage.
Read the detailed description
Conventional nasotracheal intubation techniques (or "Conventional Videolaryngoscopic Techniques," CVT) are known to be associated with significant trauma to the patient's nares and the endotracheal tube itself. The investigators propose an alternative technique (Nasotracheal intubation over a bougie placed via a subsequently removed nasal trumpet, or NIB) which involves using Seldinger technique over a bougie placed via a nasal trumpet which promises to not only be less traumatic to the patient and the endotracheal tube, but also to take less time to perform and have a higher first-attempt success rate than conventional methods. The investigators propose a randomized prospective interventional study comparing this new technique with conventional technique to see if a significant difference exists.
- Conditions
- Nasotracheal Intubation, Nasal Bleeding
- Being tested
- Nasotracheal intubation over a bougie, Conventional Nasotracheal Intubation
- Keywords
- Nasotracheal Intubation
- Medical subject headings
- Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasotracheal intubation over a bougieProcedure or surgery
Also called Abrons technique for nasotracheal intubation, Nasotracheal intubation over a bougie placed via a subsequently removed nasal trumpet, NIB
Nasotracheal intubation over a bougie, placed with videolaryngoscopy assistance, via a nasopharyngeal airway with or without the aid of Magill forceps
Conventional Nasotracheal IntubationProcedure or surgery
Also called CVT
Blind passage of an endotracheal tube via the nare followed by videolaryngoscopy-assisted passage through the glottis, with or without the aid of Magill forceps
| Study group | Role | What they receive |
|---|---|---|
| Conventional Nasotracheal Intubation (CVT) | Active comparator | Blind passage of an endotracheal tube via the nare followed by videolaryngoscopy-assisted passage through the glottis, with or without the aid of Magill forceps Receives: Procedure: Conventional Nasotracheal Intubation |
| Nasotracheal Intubation Over a Bougie (NIB) | Experimental | Nasotracheal intubation over a bougie, placed with videolaryngoscopy assistance, via a nasopharyngeal airway with or without the aid of Magill forceps Receives: Procedure: Nasotracheal intubation over a bougie |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal trauma
Bleeding noted on nasopharyngeal exam by surgical resident
Measured: 60-90 seconds post-intubation
Secondary outcomes (4)
Nasal trauma
Bleeding noted on nasopharyngeal exam by surgical resident
Measured: 5 minutes post-intubation
Time to intubation
Time from first entrance of ETT or bougie into the nare to the presence of end-tidal CO2 via nasotracheal ETT
Measured: Measured immediately post-intubation
First attempt success rate
Whether or not there was successful nasotracheal intubation on the first attempt
Measured: Measured immediately post-intubation
Need for Magill forceps
Whether or not Magill forceps were used during airway management
Measured: Measured Immediately post-intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startMar 2012
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nasotracheal 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abrons, Ron O, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003455
- Sponsor's protocol ID
- 201112757
- Status last verified
- Dec 2016
- First submitted
- 19 Dec 2016
- Last updated
- 28 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Elwood T, Stillions DM, Woo DW, Bradford HM, Ramamoorthy C. Nasotracheal intubation: a randomized trial of two methods. Anesthesiology. 2002 Jan;96(1):51-3. doi: 10.1097/00000542-200201000-00014.
PubMed 11753001O'Connell JE, Stevenson DS, Stokes MA. Pathological changes associated with short-term nasal intubation. Anaesthesia. 1996 Apr;51(4):347-50. doi: 10.1111/j.1365-2044.1996.tb07746.x.
PubMed 8686823Morimoto Y, Sugimura M, Hirose Y, Taki K, Niwa H. Nasotracheal intubation under curve-tipped suction catheter guidance reduces epistaxis. Can J Anaesth. 2006 Mar;53(3):295-8. doi: 10.1007/BF03022218.
PubMed 16527796Abrons RO, Vansickle RA, Ouanes JP. Seldinger technique for nasal intubation: a case series. J Clin Anesth. 2016 Nov;34:609-11. doi: 10.1016/j.jclinane.2016.06.027. Epub 2016 Jul 19.
PubMed 27687457Cossham PS. Nasotracheal tube placement over a bougie. Anaesthesia. 1997 Feb;52(2):184-5. No abstract available.
PubMed 9059115
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasotracheal Intubation Over a Bougie Placed Via a Subsequently Removed Nasal Trumpet
- ClinicalTrials.gov ID
- NCT03003455
- Acronym / sponsor ID
- 201112757
- Conditions
- Nasotracheal Intubation, Nasal Bleeding
- Keywords
- Nasotracheal Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 28 Dec 2016 (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 whether nasal intubation over a bougie placed via a nasal trumpet will decrease nasal trauma when compared to the conventional technique of blind nasal endotracheal tube passage.
Detailed description
Conventional nasotracheal intubation techniques (or "Conventional Videolaryngoscopic Techniques," CVT) are known to be associated with significant trauma to the patient's nares and the endotracheal tube itself. The investigators propose an alternative technique (Nasotracheal intubation over a bougie placed via a subsequently removed nasal trumpet, or NIB) which involves using Seldinger technique over a bougie placed via a nasal trumpet which promises to not only be less traumatic to the patient and the endotracheal tube, but also to take less time to perform and have a higher first-attempt success rate than conventional methods. The investigators propose a randomized prospective interventional study comparing this new technique with conventional technique to see if a significant difference exists.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Nasotracheal Intubation (CVT) | Active comparator | Procedure: Conventional Nasotracheal IntubationBlind passage of an endotracheal tube via the nare followed by videolaryngoscopy-assisted passage through the glottis, with or without the aid of Magill forceps |
| Nasotracheal Intubation Over a Bougie (NIB) | Experimental | Procedure: Nasotracheal intubation over a bougieNasotracheal intubation over a bougie, placed with videolaryngoscopy assistance, via a nasopharyngeal airway with or without the aid of Magill forceps |
Who may qualify
- Ages
- 8 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for elective surgery with an anesthetic plan including asleep nasotracheal intubation
Key exclusion criteria (9 listed)
- Patients needing emergent airway protection
- Patients undergoing emergency surgery
- Patients whom are known to be pregnant
- Patients whom are currently anticoagulated (including daily aspirin use)
- Patients whose anesthetic includes the use of nitrous oxide
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 |
|---|---|---|
| Nasotracheal intubation over a bougieAlso: Abrons technique for nasotracheal intubation, Nasotracheal intubation over a bougie placed via a subsequently removed nasal trumpet, NIBNasotracheal intubation over a bougie, placed with videolaryngoscopy assistance, via a nasopharyngeal airway with or without the aid of Magill forceps | Procedure or surgery | Nasotracheal Intubation Over a Bougie (NIB) |
| Conventional Nasotracheal IntubationAlso: CVTBlind passage of an endotracheal tube via the nare followed by videolaryngoscopy-assisted passage through the glottis, with or without the aid of Magill forceps | Procedure or surgery | Conventional Nasotracheal Intubation (CVT) |
Primary outcome
Nasal trauma
Time frame: 60-90 seconds post-intubation
Bleeding noted on nasopharyngeal exam by surgical resident
4 secondary outcomes
Nasal trauma
Time frame: 5 minutes post-intubation
Time to intubation
Time frame: Measured immediately post-intubation
First attempt success rate
Time frame: Measured immediately post-intubation
Need for Magill forceps
Time frame: Measured Immediately post-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 Dec 2016.
- Background: PubMed 11753001Elwood T, Stillions DM, Woo DW, Bradford HM, Ramamoorthy C. Nasotracheal intubation: a randomized trial of two methods. Anesthesiology. 2002 Jan;96(1):51-3. doi: 10.1097/00000542-200201000-00014.
- Background: PubMed 8686823O'Connell JE, Stevenson DS, Stokes MA. Pathological changes associated with short-term nasal intubation. Anaesthesia. 1996 Apr;51(4):347-50. doi: 10.1111/j.1365-2044.1996.tb07746.x.
- Background: PubMed 16527796Morimoto Y, Sugimura M, Hirose Y, Taki K, Niwa H. Nasotracheal intubation under curve-tipped suction catheter guidance reduces epistaxis. Can J Anaesth. 2006 Mar;53(3):295-8. doi: 10.1007/BF03022218.
- Background: PubMed 27687457Abrons RO, Vansickle RA, Ouanes JP. Seldinger technique for nasal intubation: a case series. J Clin Anesth. 2016 Nov;34:609-11. doi: 10.1016/j.jclinane.2016.06.027. Epub 2016 Jul 19.
- Background: PubMed 9059115Cossham PS. Nasotracheal tube placement over a bougie. Anaesthesia. 1997 Feb;52(2):184-5. No abstract available.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasotracheal intubation over a bougie and Conventional Nasotracheal Intubation in people with Nasotracheal Intubation and Nasal Bleeding, run by University of Iowa 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 9 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 Dec 2016. 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?
Nasal trauma (time frame: 60-90 seconds post-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 NCT03003455, which also lists 5 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 Dec 2016.