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NCT Number: NCT06986187

Difficult Airway Incidence in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Dificult mask ventilation

    Time frame: 5 minutes after anesthesia induction

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

  2. Laringeal view score

    Time frame: 5 minutes after anesthesia induction

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

  3. LEMON score

    Time frame: preoperative day

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Dilek Unal, Prof.

CONTACT

[email protected]

+90 533 695 78 55

Sponsors and collaborators

Lead sponsor

Diskapi Teaching and Research Hospital

Other

Registry information

Official study title

Investigation of Difficult Airway and Difficult Intubation Incidence and Associated Factors in Patients Undergoing Cardiovascular Surgery and a Prediction Model Development

Acronym: DAPCAP

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 22, 2025
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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