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RecruitingNCT06986187DAPCAPUpdated Feb 5, 2026

Difficult Airway Incidence in Cardiovascular Surgery and a Prediction Model Development

An observational study in Difficult Airway Intubation, Difficult Airway and Difficult Intubation, sponsored by Diskapi Teaching and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-05.

Sponsored by Diskapi Teaching and Research Hospital · Observational

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 4 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years and older
Sex
All
01

Study 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. 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.

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Conditions studied

  • 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
03

In context

Lead sponsor

Diskapi Teaching and Research Hospital is the lead sponsor of 101 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients undergoing cardiac surgery at the Cardiovascular Surgery Department of Etlik City Hospital, Ankara.

Inclusion criteria

  • Undergoing cardiovascular surgery
  • ASA I-IV physical status
  • Over 18 years of age

Exclusion criteria

Exclusion Criteria:

  • Known difficult airway
  • Head-neck and upper airway pathology
  • Patients at risk of aspiration
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Intubation difficulty

    Intubation difficulty is defined with the intubation difficulty scale score and a score greater or equal to 5 is difficult intubation

    Time frame: 5 minutes after anesthesia induction

Secondary outcomes

  1. Dificult mask ventilation

    Difficult mask ventilation is defined by Han scale score, a grade greater or equal to 1 is difficult mask ventilation

    Time frame: 5 minutes after anesthesia induction

  2. Laringeal view score

    Cormack lehanne score will be used , a score greater or equal to 2b is considered predictive of difficult airway

    Time frame: 5 minutes after anesthesia induction

  3. 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

    Time frame: preoperative day

07

Study locations

1 of 1 sites recruiting
  • Etlik City Hospital
    Ankara, 06170, Turkey (Türkiye)
    Recruiting
08

References and documents

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 36006056 ↗
  • Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11. PubMed 6507827 ↗
  • doi: https://doi.org/10.1097/ALN.0000000000004002

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06986187
Lead sponsor
Diskapi Teaching and Research Hospital
Responsible party
DILEK YAZICIOGLU (Professor of Anesthesiology, Diskapi Teaching and Research Hospital) — Principal investigator
First posted
May 22, 2025
Start date
Jun 1, 2025
Primary completion
Jun 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Feb 5, 2026

Study contacts

Dilek Unal, Prof.
Contact
dilekunalmd@gmail.com
+90 533 695 78 55
Dilek Unal, Prof.
principal investigator · Ankara Etlik City Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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