Difficult Airway IntubationNCT04140981
Comparison of Ultrasonographic and Anthropometric Measurements in Difficult Airway Evaluation
An observational study of Difficult Airway Intubation, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
In this study, anthropometric measurements (clinical measurements) will be applied in all patient groups; expected (to be difficult to provide airway patency as a result of detailed history, physical examination and evaluation tests performed by an experienced anesthesiologist), and unexpected (although it was not… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Difficult Airway Intubation
- What is being tested?
- ultrasounography
- Type of treatment
- Medical device
- How many people
- 127 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2019to 1 Dec 2019
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ASA 1-2-3, 18-75 aged, patients undergoing general anesthesia
Who may be able to join
- patients under general anesthesia
- ASA 1-2-3
Who cannot join
- Patients who will undergo emergency surgery,
- pregnant women,
- children,
- patients who may have difficulty in airway management due to cervical instability,
- patients with trauma or malignancy in the neck region
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırıkkale Univercity Faculty of Medicine Hospital
Kirikkale, 71450
About this study
Official title: Evaluation of Ultrasounographic Measurements and Anthropometric Measurements as Predictors of Difficult Direct Laryngoscopy
In this study, anthropometric measurements (clinical measurements) will be applied in all patient groups; expected (to be difficult to provide airway patency as a result of detailed history, physical examination and evaluation tests performed by an experienced anesthesiologist), and unexpected (although it was not predicted that a difficulty was encountered). And ultrasounographic measurements will be applied in all patients. The aim of this study is to evaluate the predictive accuracy of ultrasonographic measurements.
Read the detailed description
In the preoperative period, the following clinical tests will be performed before the patient arrives in the operating room and when the patient arrives, the measurements will be made by ultrasonography.
- Mallampati classification
- Determination of mouth opening (interinsizer distance)
- Thyromental distance
- Sternomental distance
Preoperative evaluation of the patients and clinical results of the airway tests (mentioned above) will be recorded. The cervical soft tissue thickness will be measured and recorded at 3 levels (thyrohyoid membrane, vocal cord, hyoid bone) with the help of ultrasonography (mentioned above). In addition, since all patients will be under general anesthesia, laryngoscopic images (laryngoscopic evaluation according to Cormack Lehane classification) routinely recorded on the anesthesia follow-up sheet will be recorded.
- Conditions
- Difficult Airway Intubation
- Being tested
- ultrasounography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasounographyDevice
in preoperative period, airway ultrasounagraphy for all patients will be made
| Study group | Role | What they receive |
|---|---|---|
| group 1 | difficult intubation according to antropometric measurements Receives: Device: ultrasounography | |
| group 2 | not difficult intubation according to antropometric measurements Receives: Device: ultrasounography | |
| group 3 | difficult intubation according to ultrasound measurements Receives: Device: ultrasounography | |
| group 4 | not difficult intubation according to ultrasound measurements Receives: Device: ultrasounography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cormack Lehane classification
Laryngoscopic evaluation according to Cormack Lehane classification
Measured: during the intubation period
Secondary outcomes (1)
ultrasonographic measurement
Preoperative ultrasonographic measurement will be made
Measured: 15 min before the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start1 Oct 2019
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult Airway 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevser Peker, Kırıkkale University
- Investigators
- Kevser Peker, Principal investigator, Kırıkkale University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140981
- Sponsor's protocol ID
- airway ultrasounography
- Status last verified
- Dec 2019
- First submitted
- 24 Oct 2019
- Last updated
- 20 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ultrasounographic Measurements and Anthropometric Measurements as Predictors of Difficult Direct Laryngoscopy
- ClinicalTrials.gov ID
- NCT04140981
- Acronym / sponsor ID
- airway ultrasounography
- Conditions
- Difficult Airway Intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 28 Oct 2019 (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.
In this study, anthropometric measurements (clinical measurements) will be applied in all patient groups; expected (to be difficult to provide airway patency as a result of detailed history, physical examination and evaluation tests performed by an experienced anesthesiologist), and unexpected (although it was not predicted that a difficulty was encountered). And ultrasounographic measurements will be applied in all patients. The aim of this study is to evaluate the predictive accuracy of ultrasonographic measurements.
Detailed description
In the preoperative period, the following clinical tests will be performed before the patient arrives in the operating room and when the patient arrives, the measurements will be made by ultrasonography.
- Mallampati classification
- Determination of mouth opening (interinsizer distance)
- Thyromental distance
- Sternomental distance
Preoperative evaluation of the patients and clinical results of the airway tests (mentioned above) will be recorded. The cervical soft tissue thickness will be measured and recorded at 3 levels (thyrohyoid membrane, vocal cord, hyoid bone) with the help of ultrasonography (mentioned above). In addition, since all patients will be under general anesthesia, laryngoscopic images (laryngoscopic evaluation according to Cormack Lehane classification) routinely recorded on the anesthesia follow-up sheet will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Device: ultrasounographydifficult intubation according to antropometric measurements |
| group 2 | – | Device: ultrasounographynot difficult intubation according to antropometric measurements |
| group 3 | – | Device: ultrasounographydifficult intubation according to ultrasound measurements |
| group 4 | – | Device: ultrasounographynot difficult intubation according to ultrasound measurements |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ASA 1-2-3, 18-75 aged, patients undergoing general anesthesia
Key inclusion criteria (2 listed)
- patients under general anesthesia
- ASA 1-2-3
Key exclusion criteria (5 listed)
- Patients who will undergo emergency surgery,
- pregnant women,
- children,
- patients who may have difficulty in airway management due to cervical instability,
- patients with trauma or malignancy in the neck region
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 |
|---|---|---|
| ultrasounographyin preoperative period, airway ultrasounagraphy for all patients will be made | Device | group 1, group 2, group 3, group 4 |
Primary outcome
Cormack Lehane classification
Time frame: during the intubation period
Laryngoscopic evaluation according to Cormack Lehane classification
1 secondary outcome
ultrasonographic measurement
Time frame: 15 min before the operation
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 20 Dec 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Difficult Airway Intubation
Enrolling by invitation
Pediatric Intubation Simulations With Bougie
Difficult Airway Intubation
Not yet recruitingObservational study
Sniper Intubation for Training of Undergraduate Medical Student
Intubation;Difficult
RecruitingObservational study
Airway Ultrasound in Oncologic Maxillofacial Patients
Head and Neck Cancer
Not yet recruitingObservational study
Sniffing Position vs Left Head Rotation (LeHeR) Maneuver for Glottic View During Direct Laryngoscopy
Difficult Intubation, Laryngoscopy
Not yet recruitingObservational study
LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway
Difficult Airway, Difficult Intubation
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.
Kevser Peker principal investigator
Kırıkkale University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Difficult Airway Intubation, run by Kırıkkale 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 2 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 20 Dec 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?
Cormack Lehane classification (time frame: during the intubation period). 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 20 Dec 2019.