Difficult Airway Incidence in Cardiovascular Surgery and a Prediction Model Development

NCT06986187 | Recruiting

• 1 other identifier: AEŞH-EK-2025-087
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

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

  5 minutes after anesthesia induction

Secondary Outcomes (3)

• Dificult mask ventilation

  5 minutes after anesthesia induction

• Laringeal view score

  5 minutes after anesthesia induction

• LEMON score

  preoperative day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (1)

Etlik City Hospital

Ankara, 06170, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 36006056 BACKGROUND

• Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.

  PMID: 6507827 BACKGROUND

• doi: https://doi.org/10.1097/ALN.0000000000004002

  BACKGROUND

Study Officials

• Dilek Unal, Prof.

  Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dilek Unal, Prof.

CONTACT

+90 533 695 78 55; dilekunalmd@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 22, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)