Difficult AirwayNCT05519358
Midsagittal Tongue Measurement to Predict Difficult Airways
An observational study of Difficult Airway and Ultrasonography, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
An unanticipated difficult airway is a potentially life-threatening event during elective surgery or management of critical conditions. However, the common clinical screening tests, show low sensitivity and specificity with a limited predictive value. Recently, ultrasound has been used to identify difficult airway. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Difficult Airway, Ultrasonography
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Sep 2022to 25 Mar 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 90 years
- All sexes
- Adult, Older adult
Study population: Patients who are18 to 90 years old and of either sex who required general anesthesia with tracheal intubation for bariatric surgery .
Who may be able to join
- American Society of Anesthesiologists (ASA) physical condition I-II-III
- Patients are required general anesthesia with tracheal intubation for bariatric surgery.
Who cannot join
- Patients with maxillofacial deformity, trauma, or tumor
- Patients with identified difficult airway or difficult airway history
- Patients with cancellation of tracheal intubation for a non-difficult airway reason
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun University Faculty of medicine
Samsun, 55040
About this study
Official title: Efficacy of Midsagittal Tongue Cross-section Area Measured by Ultrasound in Predicting Difficult Airway in Obesity Surgery Patients
An unanticipated difficult airway is a potentially life-threatening event during elective surgery or management of critical conditions. However, the common clinical screening tests, show low sensitivity and specificity with a limited predictive value. Recently, ultrasound has been used to identify difficult airway. Tongue volume is one of the parameters evaluated by ultrasound. In this study, we aim to evaluate the capacity of mid-sagittal tongue CSA and tongue width to predict difficult laryngoscopy and difficult intubation.
Read the detailed description
Anatomical changes that adversely affect airway accessibility due to increased adipose tissue in obese patients make it difficult to establish an advanced airway by orotracheal intubation. Difficulty with airway management for anesthesia has potentially serious implications, as failure to secure a patent airway can result in hypoxic brain injury or death in a matter of minutes. There have been no effective methods to predict difficult airways accurately. Ultrasonography is a non-invasive, safe, and painless modality for evaluating soft tissues. In recent years, studies have been carried out on the parameters that can be used in determining the difficult airway with ultrasound. These include the distance from the skin to the epiglottis, the tongue thickness, the tongue volume, the mandibular condylar mobility, and the visibility of the hyoid. Few studies have whether midsagittal tongue cross section area and tongue width can also be used to predict difficult airways similarly to tongue volume. Therefore, this study was designed to evaluate the predictive value of accurately measured tongue thickness and cross-sectional tongue area using ultrasonography for predicting difficult tracheal intubation and difficult laryngoscopy.
- Conditions
- Difficult Airway, Ultrasonography
- Keywords
- Airway management, Ultrasonography, Tongue widht
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 |
|---|---|---|
| difficult airway | difficult laryngoscopy; Cormack-Lehane grades 3 or 4 or Difficult intubation; Intubation Difficulty Scale (IDS)> 5 .IDS based on parameters known to be associated with difficult intubation | |
| non difficult airway | not difficult intubation or laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
midsagittal tongue cross- sectional area
To evaluate the capability of midsagittal tongue cross- sectional area measured by ultrasound to predict difficult laryngoscopy and difficult intubation.
Measured: All of the enrolled patients received ultrasonic measurement in the operation room before anesthesia on the day of surgery.
tongue width
To evaluate the capability of tongue widht measured by ultrasound to predict difficult laryngoscopy and difficult intubation.
Measured: All of the enrolled patients received ultrasonic measurement in the operation room before anesthesia on the day of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start13 Sep 2022
- Primary completion31 Dec 2023
- Study completion25 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Difficult AirwayStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suna Kara Gormus, Samsun University
- Investigators
- Suna KARAGÖRMÜŞ, Principal investigator, Samsun Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519358
- Sponsor's protocol ID
- SKara
- Status last verified
- May 2024
- First submitted
- 24 Aug 2022
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moura ECR, Filho ASM, de Oliveira EJSG, Freire TT, da Cunha Leal P, de Sousa Gomes LMR, Servin ETN, de Oliveira CMB. Comparative Study of Clinical and Ultrasound Parameters for Defining a Difficult Airway in Patients with Obesity. Obes Surg. 2021 Sep;31(9):4118-4124. doi: 10.1007/s11695-021-05528-1. Epub 2021 Jul 5.
PubMed 34227021Alessandri F, Antenucci G, Piervincenzi E, Buonopane C, Bellucci R, Andreoli C, Alunni Fegatelli D, Ranieri MV, Bilotta F. Ultrasound as a new tool in the assessment of airway difficulties: An observational study. Eur J Anaesthesiol. 2019 Jul;36(7):509-515. doi: 10.1097/EJA.0000000000000989.
PubMed 31742568Yao W, Wang B. Can tongue thickness measured by ultrasonography predict difficult tracheal intubation? Br J Anaesth. 2017 Apr 1;118(4):601-609. doi: 10.1093/bja/aex051.
PubMed 28403413
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Midsagittal Tongue Cross-section Area Measured by Ultrasound in Predicting Difficult Airway in Obesity Surgery Patients
- ClinicalTrials.gov ID
- NCT05519358
- Acronym / sponsor ID
- SKara
- Conditions
- Difficult Airway, Ultrasonography
- Keywords
- Airway management, Ultrasonography, Tongue widht
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 29 Aug 2022 (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.
An unanticipated difficult airway is a potentially life-threatening event during elective surgery or management of critical conditions. However, the common clinical screening tests, show low sensitivity and specificity with a limited predictive value. Recently, ultrasound has been used to identify difficult airway. Tongue volume is one of the parameters evaluated by ultrasound. In this study, we aim to evaluate the capacity of mid-sagittal tongue CSA and tongue width to predict difficult laryngoscopy and difficult intubation.
Detailed description
Anatomical changes that adversely affect airway accessibility due to increased adipose tissue in obese patients make it difficult to establish an advanced airway by orotracheal intubation. Difficulty with airway management for anesthesia has potentially serious implications, as failure to secure a patent airway can result in hypoxic brain injury or death in a matter of minutes. There have been no effective methods to predict difficult airways accurately. Ultrasonography is a non-invasive, safe, and painless modality for evaluating soft tissues. In recent years, studies have been carried out on the parameters that can be used in determining the difficult airway with ultrasound. These include the distance from the skin to the epiglottis, the tongue thickness, the tongue volume, the mandibular condylar mobility, and the visibility of the hyoid. Few studies have whether midsagittal tongue cross section area and tongue width can also be used to predict difficult airways similarly to tongue volume. Therefore, this study was designed to evaluate the predictive value of accurately measured tongue thickness and cross-sectional tongue area using ultrasonography for predicting difficult tracheal intubation and difficult laryngoscopy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| difficult airway | – | –difficult laryngoscopy; Cormack-Lehane grades 3 or 4 or Difficult intubation; Intubation Difficulty Scale (IDS)> 5 .IDS based on parameters known to be associated with difficult intubation |
| non difficult airway | – | –not difficult intubation or laryngoscopy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who are18 to 90 years old and of either sex who required general anesthesia with tracheal intubation for bariatric surgery .
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical condition I-II-III
- Patients are required general anesthesia with tracheal intubation for bariatric surgery.
Key exclusion criteria (3 listed)
- Patients with maxillofacial deformity, trauma, or tumor
- Patients with identified difficult airway or difficult airway history
- Patients with cancellation of tracheal intubation for a non-difficult airway reason
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
midsagittal tongue cross- sectional area
Time frame: All of the enrolled patients received ultrasonic measurement in the operation room before anesthesia on the day of surgery.
To evaluate the capability of midsagittal tongue cross- sectional area measured by ultrasound to predict difficult laryngoscopy and difficult intubation.
tongue width
Time frame: All of the enrolled patients received ultrasonic measurement in the operation room before anesthesia on the day of surgery.
To evaluate the capability of tongue widht measured by ultrasound to predict difficult laryngoscopy and difficult 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 3 Jun 2024.
- Background: PubMed 34227021Moura ECR, Filho ASM, de Oliveira EJSG, Freire TT, da Cunha Leal P, de Sousa Gomes LMR, Servin ETN, de Oliveira CMB. Comparative Study of Clinical and Ultrasound Parameters for Defining a Difficult Airway in Patients with Obesity. Obes Surg. 2021 Sep;31(9):4118-4124. doi: 10.1007/s11695-021-05528-1. Epub 2021 Jul 5.
- Background: PubMed 31742568Alessandri F, Antenucci G, Piervincenzi E, Buonopane C, Bellucci R, Andreoli C, Alunni Fegatelli D, Ranieri MV, Bilotta F. Ultrasound as a new tool in the assessment of airway difficulties: An observational study. Eur J Anaesthesiol. 2019 Jul;36(7):509-515. doi: 10.1097/EJA.0000000000000989.
- Background: PubMed 28403413Yao W, Wang B. Can tongue thickness measured by ultrasonography predict difficult tracheal intubation? Br J Anaesth. 2017 Apr 1;118(4):601-609. doi: 10.1093/bja/aex051.
- 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.
Suna KARAGÖRMÜŞ principal investigator
Samsun Univercity
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 and Ultrasonography, run by Samsun 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 3 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 3 Jun 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?
midsagittal tongue cross- sectional area (time frame: All of the enrolled patients received ultrasonic measurement in the operation room before anesthesia on the day of surgery.). The study lists 2 primary outcomes in all. 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 NCT05519358, which also lists 3 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 3 Jun 2024.