NCT06279416

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 30, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

January 15, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

February 19, 2024

Last Update Submit

January 13, 2025

Conditions

Keywords

videolaryngoscopyfiberoptic bronchoscopesupraglottic airway device

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

grup-1: awake nasal fiberoptic intubation

awake nasal fiberoptic intubation

Procedure: 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

grup-3: awake intubation with videolaryngoscopy

awake intubation with videolaryngoscopy

Procedure: videolaryngoscopy

Interventions

awake nasal fiberoptic intubation

grup-1: awake nasal fiberoptic intubation

awake intubation with laryngeal mask airway-mediated aintree catheter

grup-2: awake intubation with laryngeal mask airway-mediated aintree catheter

awake intubation with videolaryngoscopy

grup-3: awake intubation with videolaryngoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Emergency surgeries
  • Patients intubated with anesthesia
  • Noncoopere patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli City Hospital

Kocaeli, Turkey (Türkiye)

Location

Study Officials

  • Mehmet Yilmaz

    Kocaeli City Hospital Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2024

First Posted

February 28, 2024

Study Start

December 30, 2023

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

January 15, 2025

Record last verified: 2025-01

Locations