Difficult IntubationNCT03709524
Orotracheal Intubation in Adult Patients: A Comparison of Standard Airtraq , Nasotracheal Airtraq Combined With a Stylet Inserted Endotracheal Tube and Standard Airtraq Combined Fiberoptic Intubation
A study testing Airtraq + fiberoptic, Airtraq and Nasotracheal Airtraq + styletted tube in people with Difficult Intubation, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Adult patients requiring endotracheal intubation divided into three groups; standard Airtraq, Nasotracheal Airtraq + styletted endotracheal tube and Airtraq + fiberoptic combination groups. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Difficult Intubation
- What is being tested?
- Airtraq + fiberoptic, Airtraq and Nasotracheal Airtraq + styletted tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2018to 20 Feb 2019
- 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
- BMI<30
- > 18 AGE
- requiring endotracheal intubation
- ASA 1-2
Who cannot join
- BMI> 30
- < 18 AGE
- ASA III-IV
- upper respiratory infection past ten days
- pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Airtraq and Nasotracheal Airtraq for Orotracheal Intubation
Adult patients requiring endotracheal intubation divided into three groups; standard Airtraq, Nasotracheal Airtraq + styletted endotracheal tube and Airtraq + fiberoptic combination groups.
Read the detailed description
We enroll lean adult patients requiring endotracheal intubation. Using a sealed envelope technique they divided into three groups; Standard Airtraq and Nasotracheal Airtraq + styletted endotracheal tube and Standard Airtraq + fiberoptic combination. Demographic characteristics and airway management variables such; age, gender, height, weight, ASA status, tooth morphology, tiro mental and sternomental distance were recorded. Insertion times, intubation times and total intubation times with these devices will be recorded. Hemodynamic parameters recorded such as; heart rate will be recorded baseline , after anesthesia, after insertion, just after and then every 2 minutes intervals after intubation. sore throat, hoarseness, dysphasia, bronchospasm were also recorded postoperatively.
- Conditions
- Difficult Intubation
- Being tested
- Airtraq + fiberoptic, Airtraq, Nasotracheal Airtraq + styletted tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airtraq + fiberopticDevice
Also called videolaryngoscope
video laryngoscope with a monitor
AirtraqDevice
Also called videolaryngoscope
video laryngoscope with a monitor
Nasotracheal Airtraq + styletted tubeDevice
Also called videolaryngoscope
video laryngoscope with a monitor
| Study group | Role | What they receive |
|---|---|---|
| insertion time | Active comparator | 1 minute Airtraq, nasotracheal Airtraq + styletted tube and airtraq + fiberoptic Receives: Device: Airtraq + fiberoptic; Device: Airtraq; Device: Nasotracheal Airtraq + styletted tube |
| intubation time | Active comparator | 2 minutesAirtraq, nasotracheal Airtraq + styletted tube and airtraq + fiberoptic Receives: Device: Airtraq + fiberoptic; Device: Airtraq; Device: Nasotracheal Airtraq + styletted tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation time
entering the oral cavity till intubation
Measured: 6 months
Secondary outcomes (1)
insertion time
entering the oral cavity till the optimal visualization
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start15 Oct 2018
- Primary completion20 Feb 2019
- Study completion20 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Ipek ARSLAN, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709524
- Sponsor's protocol ID
- KIA 2018/446
- Status last verified
- Jun 2019
- First submitted
- 12 Oct 2018
- Last updated
- 28 Jun 2019
- 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 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Airtraq and Nasotracheal Airtraq for Orotracheal Intubation
- ClinicalTrials.gov ID
- NCT03709524
- Acronym / sponsor ID
- KIA 2018/446
- Conditions
- Difficult Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 20 Feb 2019 (actual)
- First posted
- 17 Oct 2018 (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.
Adult patients requiring endotracheal intubation divided into three groups; standard Airtraq, Nasotracheal Airtraq + styletted endotracheal tube and Airtraq + fiberoptic combination groups.
Detailed description
We enroll lean adult patients requiring endotracheal intubation. Using a sealed envelope technique they divided into three groups; Standard Airtraq and Nasotracheal Airtraq + styletted endotracheal tube and Standard Airtraq + fiberoptic combination. Demographic characteristics and airway management variables such; age, gender, height, weight, ASA status, tooth morphology, tiro mental and sternomental distance were recorded. Insertion times, intubation times and total intubation times with these devices will be recorded. Hemodynamic parameters recorded such as; heart rate will be recorded baseline , after anesthesia, after insertion, just after and then every 2 minutes intervals after intubation. sore throat, hoarseness, dysphasia, bronchospasm were also recorded postoperatively.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| insertion time | Active comparator | Device: Airtraq + fiberoptic, Device: Airtraq, Device: Nasotracheal Airtraq + styletted tube1 minute Airtraq, nasotracheal Airtraq + styletted tube and airtraq + fiberoptic |
| intubation time | Active comparator | Device: Airtraq + fiberoptic, Device: Airtraq, Device: Nasotracheal Airtraq + styletted tube2 minutesAirtraq, nasotracheal Airtraq + styletted tube and airtraq + fiberoptic |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI<30
- > 18 AGE
- requiring endotracheal intubation
- ASA 1-2
Key exclusion criteria (5 listed)
- BMI> 30
- < 18 AGE
- ASA III-IV
- upper respiratory infection past ten days
- pregnant
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 + fiberopticAlso: videolaryngoscopevideo laryngoscope with a monitor | Device | insertion time, intubation time |
| AirtraqAlso: videolaryngoscopevideo laryngoscope with a monitor | Device | insertion time, intubation time |
| Nasotracheal Airtraq + styletted tubeAlso: videolaryngoscopevideo laryngoscope with a monitor | Device | insertion time, intubation time |
Primary outcome
Intubation time
Time frame: 6 months
entering the oral cavity till intubation
1 secondary outcome
insertion time
Time frame: 6 months
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 Jun 2019.
- 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 Airtraq + fiberoptic, Airtraq and Nasotracheal Airtraq + styletted tube in people with Difficult 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 4 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 28 Jun 2019. 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?
Intubation time (time frame: 6 months). 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 28 Jun 2019.