NCT07484841

Brief Summary

The aim of this study was to compare three different awake tracheal intubation technique

  • fiberoptic bronchoscopy (ATI:FB), videolaryngoscopy (ATI:VL), and fiberoptic bronchoscopy via a supraglottic airway device (ATI:SAD)- in terms of success rates, intubation times, and complications. Additionally, the study aims to evaluate the reliability of the SAD-assisted ATI method and its potential to contribute to the literature.

Trial Health

63
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Trial Health Score

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

Enrollment
201

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress11%
Mar 2026Jun 2028

First Submitted

Initial submission to the registry

March 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

March 20, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2028

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

March 13, 2026

Last Update Submit

March 18, 2026

Conditions

Airway Management AssessmentAwake Endotracheal IntubationAwake Fiberoptic Nasal IntubationVideolaryngoscopySupraglottic Airway Device Insertion

Keywords

videolaryngoscopyawake tracheal intubationfiberoptic bronchoscopyaintree catheter

Outcome Measures

Primary Outcomes (1)

  • Success rate of chosen awake intubation method

    The primary endpoint of the study is the success rate of the selected awake intubation technique, with the intubation method to be chosen via randomization.

    Through study completion, an average of 2 year

Study Arms (3)

Fiberoptic Bronchoscopy (ATI: FOB)

ACTIVE COMPARATOR

Intubation will be perform via fiberoptic bronchoscopy

Procedure: Awake tracheal intubation viaFiberoptic Bronchoscopy (ATI:FOB)

Videolaryngoscopy (ATI:VL)

ACTIVE COMPARATOR

Intubation will be perform via videolaryngoscopy

Procedure: Awake tracheal Intubation via videolaryngoscopy (ATI:VL)

Aintree catheter loaded fiberoptic bronchoscopy via Supraglottic Airway Device (ATI:SAD)

ACTIVE COMPARATOR

Intubation will be perform via aintree catheter loaded fiberoptic bronchoscopy through supraglottic airway device

Procedure: awake tracheal intubation via aintree catheter loaded FOB through supraglottic airway device (ATI:SAD)

Interventions

Awake tracheal intubation viaFiberoptic Bronchoscopy (ATI:FOB)PROCEDURE

awake tracheal intubation will be perform via FOB

Fiberoptic Bronchoscopy (ATI: FOB)
Awake tracheal Intubation via videolaryngoscopy (ATI:VL)PROCEDURE

Awake tracheal intubation will be perform via videolaryngoscopy

Videolaryngoscopy (ATI:VL)
awake tracheal intubation via aintree catheter loaded FOB through supraglottic airway device (ATI:SAD)PROCEDURE

Awake tracheal Intubation will be perform via aintree catheter loaded FOB through supraglottic airway device

Aintree catheter loaded fiberoptic bronchoscopy via Supraglottic Airway Device (ATI:SAD)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients aged 18 and older
  • Patients classified as ASA I-II according to the American Society of Anesthesiologists (ASA) classification
  • Patients scheduled for elective surgery
  • Patients expected to require difficult mask ventilation, difficult laryngoscopy, or difficult tracheal intubation; patients expected to have short apnea periods (Planjuan goiter); patients at risk of aspiration; patients expected to require difficult rescue techniques; and patients with a reported history of difficult intubation
  • Patients scheduled for intubation using the awake tracheal intubation (ATI) method
  • Individuals who have agreed to participate in the study by signing an informed consent form

You may not qualify if:

  • Patients with a mouth opening \<1.5 cm
  • Patients requiring emergency intubation or emergency surgery (situations where there is insufficient time to administer ATI)
  • Patients who cannot cooperate (mental incapacity, impaired consciousness, inability to communicate, etc.)
  • Patients with known allergies to lidocaine or other local/topical anesthetic agents used
  • Pregnancy
  • Patients with a history of severe cardiac arrhythmia or hemodynamic instability (due to increased risk during intubation)
  • Patients who have previously undergone tracheostomy or whose airway is technically obstructed due to anatomical deformity
  • Patients who refuse to participate in the study or who do not provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli City Hospital

İzmit, Kocaeli, 41060, Turkey (Türkiye)

Location

Central Study Contacts

Mehmet Yılmaz, Assoc. Prof.

CONTACT

+905052174432drmyilmaz33@gmail.com

Ayşe Z Turan Cıvraz, Assoc.Prof.

CONTACT

05054695850ayse.zeynep@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2026

First Posted

March 20, 2026

Study Start

March 20, 2026

Primary Completion (Estimated)

March 20, 2028

Study Completion (Estimated)

June 20, 2028

Last Updated

March 20, 2026

Record last verified: 2026-03

Locations

TU(1)