Clinical trial NCT06986187: Difficult Airway and Difficult Intubation Incidence in Patients Undergoing Cardiovascular Surgery and a Prediction Model Development
Official title: Investigation of Difficult Airway and Difficult Intubation Incidence and Associated Factors in Patients Undergoing Cardiovascular Surgery and a Prediction Model Development
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cardiac surgery at the Cardiovascular Surgery Department of Etlik City Hospital, Ankara.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intubation difficulty
timeFrame: 5 minutes after anesthesia induction
Secondary outcomes:
measure: Dificult mask ventilation
timeFrame: 5 minutes after anesthesia induction
measure: Laringeal view score
timeFrame: 5 minutes after anesthesia induction
measure: LEMON score
timeFrame: preoperative day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Etlik City Hospital
Study officials:
affiliation: Ankara Etlik City Hospital
name: Dilek Unal, Professor of Anesthesiology
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.
citation: doi: https://doi.org/10.1097/ALN.0000000000004002