Airway Complication of AnesthesiaNCT06611917
Diagnostic Values of Physical Examination and Ultrasonographic Measurements in Predicting Difficult Airways
An observational study of Airway Complication of Anesthesia, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the effectiveness of ultrasonographic measurements compared to traditional physical examination tests in predicting difficult airways. With no definitive gold standard for anticipating airway challenges, this research explores the diagnostic capabilities of newer, non-invasive techniques like… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Complication of Anesthesia
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 1 Apr 2024
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients aged 18-60 years undergoing surgery under general anesthesia with an ASA classification of 1-3.
Who may be able to join
- Patients classified as American Society of Anesthesiologists (ASA) class I-II-III.
- Individuals aged between 18 and 60 years.
- Patients scheduled for elective surgery require endotracheal intubation under general anesthesia
Who cannot join
- Patients with pathologies in the airway or head and neck area (masses, cancer, congenital anomalies, acquired anatomical disorders).
- Individuals with active infections.
- Those with cervical vertebral damage.
- Patients with a history of head and neck trauma.
- Individuals who have undergone previous head and neck surgery.
- Patients with a history of head and neck radiotherapy.
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- Pregnant individuals.
- Obese patients (body mass index > 30).
- Non-cooperative patients.
- Patients are requiring surgery under emergency conditions.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Canakkale Onsekiz Mart University
Çanakkale, Merkez, 17020
About this study
Official title: Comparative Diagnostic Values of Physical Examination Tests and Ultrasonographic Measurements in Predicting Difficult Airways
This study evaluates the effectiveness of ultrasonographic measurements compared to traditional physical examination tests in predicting difficult airways. With no definitive gold standard for anticipating airway challenges, this research explores the diagnostic capabilities of newer, non-invasive techniques like ultrasonography-which is gaining popularity due to its ease of use and widespread availability-in the field of anesthesia. The study focuses on defining highly sensitive and easy-to-use ultrasonographic markers that could aid anesthesiologists, intensive care specialists, and emergency physicians in effective airway management.
Read the detailed description
Anesthesiologists, intensive care specialists, and emergency physicians frequently encounter the challenge of managing difficult airways, a critical competency as failure to secure the airway can lead to severe consequences, including brain damage or death. Intubation, a complex procedure involving several anatomical maneuvers, has traditionally relied on physical examination indicators such as dental and facial anatomy, Mallampati score, and neck mobility to predict potential difficulties. However, these methods, while useful, often lack the accuracy needed for reliable prediction, leading to a significant percentage of unexpected difficult intubations.
Recent advances in medical imaging propose the use of radiological and ultrasonographic assessments to enhance predictive accuracy. Ultrasonography, in particular, offers a non-invasive, easily accessible method for examining airway structures, which could potentially transform standard practices in airway management. The American Society of Anesthesiologists recognizes the promising role of ultrasound in airway assessment, yet acknowledges the need for more standardized approaches to its implementation.
This research aims to compare the predictive value of physical examination findings with that of ultrasonographic measurements such as the distance from skin to hyoid bone, skin to epiglottis, and tongue volume. By establishing more reliable and sensitive ultrasonographic markers, this study seeks to provide clinicians with better tools for assessing the risk of difficult airways, ultimately contributing to safer anesthesia practices and reducing the incidence of intubation-related complications.
- Conditions
- Airway Complication of Anesthesia
- Keywords
- Airway Management, Endotracheal Intubation, Ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonographic and Physical Examination Cohort | Participants in this study are patients scheduled for surgery under general anesthesia. The participants will undergo standard physical examination tests conducted by anesthesiologists before surgery and will also receive ultrasonographic measurements of the subglottic and other critical airway structures. The participants will be categorized as an observational cohort in which the ultrasonographic assessments will be compared with the results of the physical examination. The primary objective of this study is to compare the effectiveness of these two methods in predicting difficult airways. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Difficult Airway Prediction
The primary outcome measures the effectiveness of ultrasonography and physical examination in predicting difficult airways in patients undergoing general anesthesia. Occurrence of a difficult airway is the primary outcome. A difficult airway is defined by specific clinical criteria:
More than two intubation attempts, Intubation time exceeding 10 minutes, or Cormack-Lehane laryngoscopy grade of 3 or 4. Data will be collected during the intubation process. Intubation attempts and time will be recorded by the anesthesiologist, while the Cormack-Lehane grading will be assessed based on the view of the glottis during laryngoscopy.
Measurement Process:
Ultrasonographic measurements of the airway will be taken preoperatively using non-invasive ultrasound techniques. Additionally, physical examination tests will be performed preoperatively to assess airway risk. The outcome is categorized as difficult airway (yes/no) based on whether the patient meets any of the defined criteria.
Measured: up to one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 Jun 2023
- Primary completion1 Dec 2023
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway Complication of AnesthesiaStudies 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çanakkale Onsekiz Mart University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Ezgi SUBASI, Çanakkale Onsekiz Mart University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611917
- Sponsor's protocol ID
- COMU-SBF-AES-01
- Status last verified
- Jul 2024
- First submitted
- 12 Jul 2024
- Last updated
- 25 Sep 2024
- 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 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Diagnostic Values of Physical Examination Tests and Ultrasonographic Measurements in Predicting Difficult Airways
- ClinicalTrials.gov ID
- NCT06611917
- Acronym / sponsor ID
- COMU-SBF-AES-01
- Conditions
- Airway Complication of Anesthesia
- Keywords
- Airway Management, Endotracheal Intubation, Ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Çanakkale Onsekiz Mart UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 25 Sep 2024 (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.
This study evaluates the effectiveness of ultrasonographic measurements compared to traditional physical examination tests in predicting difficult airways. With no definitive gold standard for anticipating airway challenges, this research explores the diagnostic capabilities of newer, non-invasive techniques like ultrasonography-which is gaining popularity due to its ease of use and widespread availability-in the field of anesthesia. The study focuses on defining highly sensitive and easy-to-use ultrasonographic markers that could aid anesthesiologists, intensive care specialists, and emergency physicians in effective airway management.
Detailed description
Anesthesiologists, intensive care specialists, and emergency physicians frequently encounter the challenge of managing difficult airways, a critical competency as failure to secure the airway can lead to severe consequences, including brain damage or death. Intubation, a complex procedure involving several anatomical maneuvers, has traditionally relied on physical examination indicators such as dental and facial anatomy, Mallampati score, and neck mobility to predict potential difficulties. However, these methods, while useful, often lack the accuracy needed for reliable prediction, leading to a significant percentage of unexpected difficult intubations.
Recent advances in medical imaging propose the use of radiological and ultrasonographic assessments to enhance predictive accuracy. Ultrasonography, in particular, offers a non-invasive, easily accessible method for examining airway structures, which could potentially transform standard practices in airway management. The American Society of Anesthesiologists recognizes the promising role of ultrasound in airway assessment, yet acknowledges the need for more standardized approaches to its implementation.
This research aims to compare the predictive value of physical examination findings with that of ultrasonographic measurements such as the distance from skin to hyoid bone, skin to epiglottis, and tongue volume. By establishing more reliable and sensitive ultrasonographic markers, this study seeks to provide clinicians with better tools for assessing the risk of difficult airways, ultimately contributing to safer anesthesia practices and reducing the incidence of intubation-related complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasonographic and Physical Examination Cohort | – | –Participants in this study are patients scheduled for surgery under general anesthesia. The participants will undergo standard physical examination tests conducted by anesthesiologists before surgery and will also receive ultrasonographic measurements of the subglottic and other critical airway structures. The participants will be categorized as an observational cohort in which the ultrasonographic assessments will be compared with the results of the physical examination. The primary objective of this study is to compare the effectiveness of these two methods in predicting difficult airways. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients aged 18-60 years undergoing surgery under general anesthesia with an ASA classification of 1-3.
Key inclusion criteria (3 listed)
- Patients classified as American Society of Anesthesiologists (ASA) class I-II-III.
- Individuals aged between 18 and 60 years.
- Patients scheduled for elective surgery require endotracheal intubation under general anesthesia
Key exclusion criteria (10 listed)
- Patients with pathologies in the airway or head and neck area (masses, cancer, congenital anomalies, acquired anatomical disorders).
- Individuals with active infections.
- Those with cervical vertebral damage.
- Patients with a history of head and neck trauma.
- Individuals who have undergone previous head and neck surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effectiveness of Difficult Airway Prediction
Time frame: up to one hour
The primary outcome measures the effectiveness of ultrasonography and physical examination in predicting difficult airways in patients undergoing general anesthesia. Occurrence of a difficult airway is the primary outcome. A difficult airway is defined by specific clinical criteria: More than two intubation attempts, Intubation time exceeding 10 minutes, or Cormack-Lehane laryngoscopy grade of 3 or 4. Data will be collected during the intubation process. Intubation attempts and time will be recorded by the anesthesiologist, while the Cormack-Lehane grading will be assessed based on the view of the glottis during laryngoscopy. Measurement Process: Ultrasonographic measurements of the airway will be taken preoperatively using non-invasive ultrasound techniques. Additionally, physical examination tests will be performed preoperatively to assess airway risk. The outcome is categorized as difficult airway (yes/no) based on whether the patient meets any of the defined criteria.
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 25 Sep 2024.
- 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?
An observational study of Airway Complication of Anesthesia, run by Çanakkale Onsekiz Mart 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 3 inclusion and 10 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 25 Sep 2024. 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?
Effectiveness of Difficult Airway Prediction (time frame: up to one hour). 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 25 Sep 2024.