Expected Difficult Airway Management

Awake Intubation Clinical Trial

Official title:

Evaluation of Advanced Airway Methods Applied to Patients Who Were Awakened Due to Difficult Airway in Another Center or Who Were Predicted to Have Difficult Airway in Preoperative Evaluation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06279416
• Other study ID #: 2023-31
• Status: Recruiting
• Start date: December 30, 2023
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Kocaeli City Hospital
• Contact: Mehmet Yilmaz
• Phone: +905052174432
• Email: drmyilmaz33[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this study, the investigators will evaluate the advanced airway methods applied in the anesthesiology and reanimation clinic of the hospital to patients who met the criteria for awake intubation specified in the ASA 2022 difficult airway management guideline or who could not be intubated after induction of anesthesia in another center. The advanced airway method applied to the difficult airway patient expected in the operating room, the duration, success and complications of the method will be observed and recorded.

Description:

Patients who meet the inclusion criteria will be informed about the difficult airway and their verbal and written consent will be obtained.

When participants are taken to the room, an observer will be in the operation room. There was no emergency to the patient's primary anesthesiologist, will not be involved. Record patients' demographic data, Mallampati scores, thyromental distance, and neck circumference.

The airway method preferred by the physician, procedure duration, number of attempts, success, and complications will be recorded.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years old

• Meets the expected difficult airway criteria

• Being awakened after induction of anesthesia in another center

• At least one of the awake intubation criteria in the DAS 2022 guideline

• Elective surgeries

Exclusion Criteria:

• Emergency surgeries

• Patients intubated with anesthesia

• Noncoopere patients

Related Conditions & MeSH terms

• Awake Intubation

Intervention

Procedure:
• fiberoptic intubation
awake nasal fiberoptic intubation
• laryngeal mask airway-mediated aintree catheter
awake intubation with laryngeal mask airway-mediated aintree catheter
• videolaryngoscopy
awake intubation with videolaryngoscopy

Locations

Country	Name	City	State
Turkey	Kocaeli City Hospital	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of advanced airway methods in the awake patient with difficult airway.	Comparison of the superiority of advanced airway methods applied to the expected difficult airway patient in the operating room. The number of attempts and duration for successful intubation between groups will be examined.	1 year