Difficult Airway IntubationDAPCAPNCT06986187
Difficult Airway Incidence in Cardiovascular Surgery and a Prediction Model Development
An observational study of Difficult Airway Intubation and Difficult Airway, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
A difficult airway is a clinical condition that occurs when one or more of the components of difficult mask ventilation, difficult laryngoscopy, difficult endotracheal intubation, difficult supraglottic airway device (SGA) placement, and inability to intubate-oxygenate are present. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficult Airway Intubation, Difficult Airway, Difficult Intubation
- How many people
- 2,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Adult, Older adult
Study population: Patients undergoing cardiac surgery at the Cardiovascular Surgery Department of Etlik City Hospital, Ankara.
Who may be able to join
- Undergoing cardiovascular surgery
- ASA I-IV physical status
- Over 18 years of age
Who cannot join
- Known difficult airway
- Head-neck and upper airway pathology
- Patients at risk of aspiration
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Etlik City Hospital
Ankara, 06170
Julide Ergil, Profesor, +905323469216, julideergil@hotmail.com
Murat Sayın, Profesor, +905326147862, muratsayin@hotmail.com
About this study
Official title: Investigation of Difficult Airway and Difficult Intubation Incidence and Associated Factors in Patients Undergoing Cardiovascular Surgery and a Prediction Model Development
A difficult airway is a clinical condition that occurs when one or more of the components of difficult mask ventilation, difficult laryngoscopy, difficult endotracheal intubation, difficult supraglottic airway device (SGA) placement, and inability to intubate-oxygenate are present. Data concerning incidence of difficult airway in patients undergoing cardiovascular surgery is controversial. Unwanted hemodynamic changes that may occur in patients undergoing cardiovascular surgery, combined with hemodynamic changes caused by underlying cardiac pathologies, may also lead to a physiologically difficult airway situation. Since all these interactions, combined with the hemodynamic changes caused by difficult airway interventions, may lead to catastrophic outcomes, it is vital to predict difficult airway in this patient population.
Read the detailed description
Difficult airway is a clinical condition that occurs when one or more of the components of difficult mask ventilation, difficult laryngoscopy, difficult endotracheal intubation, difficult supraglottic airway device (SGA) placement, and inability to intubate-oxygenate are present.
Different diagnostic criteria for all components of difficult airway and similarly different predictive criteria for the risk of occurrence in a patient have been defined. The LEMON Score, El-Ganzouri Risk Index, and Arne Score, which are evaluated by physical examination of the upper airway structures during the pre-anesthetic examination, and the Cormack-Lehane Classification (CL) used to evaluate the laryngoscopic image during intubation, can be counted among the difficult airway prediction tests.
Difficult airway situations that occur during anesthesia application can be defined by the Han Score for mask ventilation, the Intubation Difficulty Scale (IDS) for endotracheal entubation, the videolaryngoscopic intubation and difficult airway classification (VIDIAC) in patients using videolaryngoscopy, and the difficult SGA placement score.
Previous studies have reported that the incidence of difficult airway is higher in patients undergoing cardiovascular surgery compared to other patient groups. Borde et al. reported the rate of difficult intubation in patients undergoing cardiac surgery as 24%. The rate of difficult laryngoscopy in patients undergoing coronary artery surgery was reported as 10% by Ezri et al. and 7% by Heinrich et al. However, it is seen that the predictive criteria and diagnostic criteria for the components of the difficult airway are used interchangeably and incorrectly in these studies. Therefore, the current information on the incidence of difficult airways in patients undergoing cardiovascular surgery is contradictory and open to debate.
Accurate information on the incidence of difficult airway in this patient population can contribute to anesthesiology education, equipment and personnel planning, and most importantly, patient safety. Unwanted hemodynamic changes that may occur following anesthesia induction in patients undergoing cardiovascular surgery, combined with hemodynamic changes caused by underlying cardiac pathologies, may lead to the emergence of a physiological difficult airway condition. Since all these interactions, when combined with hemodynamic changes caused by difficult airway interventions, may lead to catastrophic outcomes, predicting difficult airway in this patient population is of vital importance.
Despite its clinical importance, to our knowledge, this subject has not yet been investigated in the literature with artificial intelligence algorithms.
The aim of this study is to investigate the incidence of difficult airway and difficult intubation in patients undergoing cardiovascular surgery and the associated factors and to develop a machine learning model that can predict difficult airway using artificial intelligence algorithms.
- Conditions
- Difficult Airway Intubation, Difficult Airway, Difficult Intubation, Cardiac Surgery, Cardiac Surgery in Adult Patient
- Keywords
- difficult intubation, difficult airway, difficult airway prediction, difficult airway prediction model
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation difficulty
Intubation difficulty is defined with the intubation difficulty scale score and a score greater or equal to 5 is difficult intubation
Measured: 5 minutes after anesthesia induction
Secondary outcomes (3)
Dificult mask ventilation
Difficult mask ventilation is defined by Han scale score, a grade greater or equal to 1 is difficult mask ventilation
Measured: 5 minutes after anesthesia induction
Laringeal view score
Cormack lehanne score will be used , a score greater or equal to 2b is considered predictive of difficult airway
Measured: 5 minutes after anesthesia induction
LEMON score
LEMON score is Look externally Evaluate 3-3-2 rule can 3 fingers fit in the mouth (mouth opening <5 cm) and is the mandible lenght at least 3 fingers from the mentum to the hyoid ( thyromental distance <6 cm) and is the distance from the hyoid to thyroid at least 2 fingers Mallampati class Obstruction (presence of any obstruction) Neck mobility (limited mobility)
1 point each and >10 points at risk of difficult airway
Measured: preoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start1 Jun 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
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 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
- Other
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital
- Investigators
- Dilek Unal, Prof., Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986187
- Sponsor's protocol ID
- AEŞH-EK-2025-087
- Acronym
- DAPCAP
- Status last verified
- Jan 2026
- First submitted
- 15 May 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kohse EK, Siebert HK, Sasu PB, Loock K, Dohrmann T, Breitfeld P, Barclay-Steuart A, Stark M, Sehner S, Zollner C, Petzoldt M. A model to predict difficult airway alerts after videolaryngoscopy in adults with anticipated difficult airways - the VIDIAC score. Anaesthesia. 2022 Oct;77(10):1089-1096. doi: 10.1111/anae.15841. Epub 2022 Aug 25.
PubMed 36006056Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.
PubMed 6507827doi: https://doi.org/10.1097/ALN.0000000000004002
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Difficult Airway and Difficult Intubation Incidence and Associated Factors in Patients Undergoing Cardiovascular Surgery and a Prediction Model Development
- ClinicalTrials.gov ID
- NCT06986187
- Acronym / sponsor ID
- DAPCAP / AEŞH-EK-2025-087
- Conditions
- Difficult Airway Intubation, Difficult Airway, Difficult Intubation, Cardiac Surgery, Cardiac Surgery in Adult Patient
- Keywords
- difficult intubation, difficult airway, difficult airway prediction, difficult airway prediction model
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 22 May 2025 (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.
A difficult airway is a clinical condition that occurs when one or more of the components of difficult mask ventilation, difficult laryngoscopy, difficult endotracheal intubation, difficult supraglottic airway device (SGA) placement, and inability to intubate-oxygenate are present. Data concerning incidence of difficult airway in patients undergoing cardiovascular surgery is controversial. Unwanted hemodynamic changes that may occur in patients undergoing cardiovascular surgery, combined with hemodynamic changes caused by underlying cardiac pathologies, may also lead to a physiologically difficult airway situation. Since all these interactions, combined with the hemodynamic changes caused by difficult airway interventions, may lead to catastrophic outcomes, it is vital to predict difficult airway in this patient population.
Detailed description
Difficult airway is a clinical condition that occurs when one or more of the components of difficult mask ventilation, difficult laryngoscopy, difficult endotracheal intubation, difficult supraglottic airway device (SGA) placement, and inability to intubate-oxygenate are present.
Different diagnostic criteria for all components of difficult airway and similarly different predictive criteria for the risk of occurrence in a patient have been defined. The LEMON Score, El-Ganzouri Risk Index, and Arne Score, which are evaluated by physical examination of the upper airway structures during the pre-anesthetic examination, and the Cormack-Lehane Classification (CL) used to evaluate the laryngoscopic image during intubation, can be counted among the difficult airway prediction tests.
Difficult airway situations that occur during anesthesia application can be defined by the Han Score for mask ventilation, the Intubation Difficulty Scale (IDS) for endotracheal entubation, the videolaryngoscopic intubation and difficult airway classification (VIDIAC) in patients using videolaryngoscopy, and the difficult SGA placement score.
Previous studies have reported that the incidence of difficult airway is higher in patients undergoing cardiovascular surgery compared to other patient groups. Borde et al. reported the rate of difficult intubation in patients undergoing cardiac surgery as 24%. The rate of difficult laryngoscopy in patients undergoing coronary artery surgery was reported as 10% by Ezri et al. and 7% by Heinrich et al. However, it is seen that the predictive criteria and diagnostic criteria for the components of the difficult airway are used interchangeably and incorrectly in these studies. Therefore, the current information on the incidence of difficult airways in patients undergoing cardiovascular surgery is contradictory and open to debate.
Accurate information on the incidence of difficult airway in this patient population can contribute to anesthesiology education, equipment and personnel planning, and most importantly, patient safety. Unwanted hemodynamic changes that may occur following anesthesia induction in patients undergoing cardiovascular surgery, combined with hemodynamic changes caused by underlying cardiac pathologies, may lead to the emergence of a physiological difficult airway condition. Since all these interactions, when combined with hemodynamic changes caused by difficult airway interventions, may lead to catastrophic outcomes, predicting difficult airway in this patient population is of vital importance.
Despite its clinical importance, to our knowledge, this subject has not yet been investigated in the literature with artificial intelligence algorithms.
The aim of this study is to investigate the incidence of difficult airway and difficult intubation in patients undergoing cardiovascular surgery and the associated factors and to develop a machine learning model that can predict difficult airway using artificial intelligence algorithms.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiac surgery at the Cardiovascular Surgery Department of Etlik City Hospital, Ankara.
Key inclusion criteria (3 listed)
- Undergoing cardiovascular surgery
- ASA I-IV physical status
- Over 18 years of age
Key exclusion criteria (3 listed)
- Known difficult airway
- Head-neck and upper airway pathology
- Patients at risk of aspiration
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
Intubation difficulty
Time frame: 5 minutes after anesthesia induction
Intubation difficulty is defined with the intubation difficulty scale score and a score greater or equal to 5 is difficult intubation
3 secondary outcomes
Dificult mask ventilation
Time frame: 5 minutes after anesthesia induction
Laringeal view score
Time frame: 5 minutes after anesthesia induction
LEMON score
Time frame: preoperative day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Background: PubMed 36006056Kohse EK, Siebert HK, Sasu PB, Loock K, Dohrmann T, Breitfeld P, Barclay-Steuart A, Stark M, Sehner S, Zollner C, Petzoldt M. A model to predict difficult airway alerts after videolaryngoscopy in adults with anticipated difficult airways - the VIDIAC score. Anaesthesia. 2022 Oct;77(10):1089-1096. doi: 10.1111/anae.15841. Epub 2022 Aug 25.
- Background: PubMed 6507827Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.
- Backgrounddoi: https://doi.org/10.1097/ALN.0000000000004002
- Individual participant dataSharing planned: No
Related trials for Difficult Airway Intubation
Not yet recruitingObservational study
LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway
Difficult Airway, Difficult Intubation
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
A Novel Score for Procedural Difficulty During Videolaryngoscopic Intubation
Intubation, Intratracheal, Airway Management
RecruitingObservational study
Comparison of Two Sedation Regimens for Awake Fiberoptic Intubation
Awake Fiberoptic Intubation, Difficult Airway
Not yet recruitingObservational study
Modified El-Ganzouri Risk Index for Predicting Difficult Intubation in Obese Patients
Difficult Intubation, Obesity
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.
Dilek Unal, Prof. principal investigator
Ankara Etlik City Hospital
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 and Difficult Airway, run by Diskapi Teaching and Research Hospital 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 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: looking for participants now, as of the sponsor's last update on 5 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dilek Unal, Prof. (+90 533 695 78 55, dilekunalmd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intubation difficulty (time frame: 5 minutes after anesthesia induction). 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 NCT06986187, 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 5 Feb 2026.