Expected Difficult Airway Management

January 13, 2025 updated by: Kocaeli City Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kocaeli, Turkey
        • Kocaeli City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients who were previously evaluated for difficult airway criteria and predicted to have a difficult airway or who could not be ventilated or intubated after induction of anesthesia in another center.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
grup-1: awake nasal fiberoptic intubation
awake nasal fiberoptic intubation
Procedure: fiberoptic intubation
awake nasal fiberoptic intubation
grup-2: awake intubation with laryngeal mask airway-mediated aintree catheter
awake intubation with laryngeal mask airway-mediated aintree catheter
Procedure: laryngeal mask airway-mediated aintree catheter
awake intubation with laryngeal mask airway-mediated aintree catheter
grup-3: awake intubation with videolaryngoscopy
awake intubation with videolaryngoscopy
Procedure: videolaryngoscopy
awake intubation with videolaryngoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of advanced airway methods in the awake patient with difficult airway.
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli City Hospital

Investigators

  • Principal Investigator: Mehmet Yilmaz, Kocaeli City Hospital Anesthesiology and Reanimation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2023

Primary Completion (Actual)

December 30, 2024

Study Completion (Actual)

December 30, 2024

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023-31

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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