Nasotracheal IntubationNCT03226002
Which Nostril Should be Used for Nasotracheal Intubation With Airtraq NT®: the Right or Left? A Randomized Clinical Trial
A study testing Airtraq NT in people with Nasotracheal Intubation, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
After Ethics committee approval investigators decided to enroll 40 patients ASA I-II, 18-60 years of age undergoing maxillofascial, oral and double chin surgery to determine which nostril is more suitable for nasotracheal intubation with nasotracheal Airtraq. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasotracheal Intubation
- What is being tested?
- Airtraq NT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2017to 10 Sep 2017
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years of age
- undergoing elective maxillofacial surgery
- dental surgery
- plastic surgery requiring nasotracheal intubation
- ASA I-II
Who cannot join
- >18 years and > 65 years
- BMI> 35
- ASA III-IV
- fasted patients
- patients do not require nasotracheal intubation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli University School of Medicine
Kocaeli, 41900
About this study
After Ethics committee approval investigators decided to enroll 40 patients ASA I-II, 18-60 years of age undergoing maxillofascial, oral and double chin surgery to determine which nostril is more suitable for nasotracheal intubation with nasotracheal Airtraq. We primay aimed to compare the glottis visualization time, intubation time and total intubation times.
Read the detailed description
After Ethics committee approval, investigators decided to enroll 40 pateints ASA I-II, 18-60 years of age undergoing maxillofascial, oral and double chin surgery to determine which nostril is more suitable for nasotracheal intubation with nasotracheal Airtraq. In addition is the 90° anti-clockwise rotation of the tip of the tube helpful to insert the tube into the trachea. Patients were randomized into right and the left nostril groups. After standard anesthesia induction with propofol and fentanyl, rocuronium was used for muscle relaxation. Primary aim of this prospective study was to compare the glottis visualization time, intubation time and total intubation times. The Cormack-Lehane grades, the need for optimization, tube adjustment maneuvers, hemodynamic data, occurrence of epistaxis of the patients were recorded during the process.
- Conditions
- Nasotracheal Intubation
- Being tested
- Airtraq NT
- Keywords
- Airtraq NT, nasotracheal intubation, right, left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airtraq NTDevice
channeled video laryngoscope for nasotracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| Airtraq NT right nostril | Active comparator | nasotracheal intubation with Airtraq NT through the right nostril Receives: Device: Airtraq NT |
| Airtraq NT left nostril | Active comparator | nasotracheal intubation with Airtraq NT through the left nostril Receives: Device: Airtraq NT |
What is being measured
The primary outcome is the main question the study is designed to answer.
insertion time of the device
handling the device till the optimal glottis visualization occurred
Measured: 20 seconds
nasotracheal intubation time with the device
handling the device till the visualization of tracheal tube through the vocal cords
Measured: 30 seconds
total nasotracheal intubation time with the device
handling the device till the confirmation of nasotracheal intubation with end-tidal carbodioxide
Measured: 40 seconds
Secondary outcomes (2)
optimisation maneuvers during intubation with the device
need for optimisation maneuvers during nasotracheal intubation
Measured: 20 seconds
minor complications related to the device
epistaxis, nose pain, bronchospasm
Measured: 40 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start1 Apr 2017
- Primary completion1 Sep 2017
- Study completion10 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Ipek ARSLAN, Kocaeli University
- Investigators
- zehra I Arslan, Principal investigator, Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226002
- Sponsor's protocol ID
- KÜ GOKAEK 2017/71
- Status last verified
- Aug 2018
- First submitted
- 18 Jul 2017
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which Nostril Should be Used for Nasotracheal Intubation With Airtraq NT®: the Right or Left? A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03226002
- Acronym / sponsor ID
- KÜ GOKAEK 2017/71
- Conditions
- Nasotracheal Intubation
- Keywords
- Airtraq NT, nasotracheal intubation, right, left
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 10 Sep 2017 (actual)
- First posted
- 21 Jul 2017 (actual)
- 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.
After Ethics committee approval investigators decided to enroll 40 patients ASA I-II, 18-60 years of age undergoing maxillofascial, oral and double chin surgery to determine which nostril is more suitable for nasotracheal intubation with nasotracheal Airtraq. We primay aimed to compare the glottis visualization time, intubation time and total intubation times.
Detailed description
After Ethics committee approval, investigators decided to enroll 40 pateints ASA I-II, 18-60 years of age undergoing maxillofascial, oral and double chin surgery to determine which nostril is more suitable for nasotracheal intubation with nasotracheal Airtraq. In addition is the 90° anti-clockwise rotation of the tip of the tube helpful to insert the tube into the trachea. Patients were randomized into right and the left nostril groups. After standard anesthesia induction with propofol and fentanyl, rocuronium was used for muscle relaxation. Primary aim of this prospective study was to compare the glottis visualization time, intubation time and total intubation times. The Cormack-Lehane grades, the need for optimization, tube adjustment maneuvers, hemodynamic data, occurrence of epistaxis of the patients were recorded during the process.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Airtraq NT right nostril | Active comparator | Device: Airtraq NTnasotracheal intubation with Airtraq NT through the right nostril |
| Airtraq NT left nostril | Active comparator | Device: Airtraq NTnasotracheal intubation with Airtraq NT through the left nostril |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-65 years of age
- undergoing elective maxillofacial surgery
- dental surgery
- plastic surgery requiring nasotracheal intubation
- ASA I-II
Key exclusion criteria (5 listed)
- >18 years and > 65 years
- BMI> 35
- ASA III-IV
- fasted patients
- patients do not require nasotracheal intubation
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 |
|---|---|---|
| Airtraq NTchanneled video laryngoscope for nasotracheal intubation | Device | Airtraq NT left nostril, Airtraq NT right nostril |
Primary outcome
insertion time of the device
Time frame: 20 seconds
handling the device till the optimal glottis visualization occurred
nasotracheal intubation time with the device
Time frame: 30 seconds
handling the device till the visualization of tracheal tube through the vocal cords
total nasotracheal intubation time with the device
Time frame: 40 seconds
handling the device till the confirmation of nasotracheal intubation with end-tidal carbodioxide
2 secondary outcomes
optimisation maneuvers during intubation with the device
Time frame: 20 seconds
minor complications related to the device
Time frame: 40 seconds
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 7 Aug 2018.
- 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.
zehra I Arslan principal investigator
Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airtraq NT in people with Nasotracheal Intubation, run by Kocaeli University at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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 7 Aug 2018. 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 Turkey (Türkiye). 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?
insertion time of the device (time frame: 20 seconds). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2018.