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CompletedNCT05187052RigidscopesUpdated Jan 11, 2022

Rigid Telescopes, C-MAC, Flexible Bronchoscopy for Intubation in Patients With Anticipated Difficult Airways

An observational study in Videolaryngoscopy, sponsored by Yuzuncu Yıl University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-01-11.

Sponsored by Yuzuncu Yıl University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 90 Years
Sex
All
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Study summary

The primary outcome of the study is the first-attempt orotracheal intubation success rate and the secondary outcomes include intubation time, mucosal injury, and complications during intubation.

Read the detailed description

Difficult airway management in phonomicrosurgery requiring endotracheal tube (ETT) placement is highly important for both the anesthetist and the surgeon. The use of rigid telescopes in the intubation of children with difficult intubation, such as those with Pierre Robin sequence (PRS), has been previously described in the literature. In addition, the use of Airtraq™ and rigid endoscopes in patients undergoing phonomicrosurgery, particularly in patients with difficult laryngoscopy, has also been reported in the literature. However, the uses of these techniques have mostly been described in the administration of surgery or in defining airway disease. In this study, we aimed to evaluate the use of rigid telescopes during intubation, particularly in patients with a difficult airway, and to compare them with videolaryngoscope Macintosh (V-MAC) and flexible fiberoptic bronchoscope.

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Conditions studied

  • Videolaryngoscopy

Keywords

  • Airway management, Difficult airway, Tracheal intubation
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In context

Lead sponsor

Yuzuncu Yıl University is the lead sponsor of 124 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Difficult airway management in phonomicrosurgery requiring endotracheal tube (ETT) between 18-90 years old patients.

Inclusion criteria

Patients with a modified Cormack-Lehane (C-L) grade of 3 and 4, Wilson score of ≥ 6, Thyromental distance (TMD) distance of ≤ 6 cm, Sternomental distance (SMD) ≤ 13.

Exclusion criteria

Exclusion Criteria:

Patients that had severe mouth opening (\<2.5 cm), Required nasotracheal intubation, Upper airway and pharyngeal diseases, Presence of cervical spine anomalies, Emergency procedures, Failed mask ventilation, ASA III and IV score, Patients who were allergic to any of the drugs to be used during premedication and anesthesia.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
150 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Group 1 (REI group)

    Group 1 included patients that were intubated using rigid endoscope-assisted orotracheal intubation (REI) (0°, 45°, and 70°), 18-cm rigid telescope (Storz, Germany), full-HD camera (Olympus, USA), and Macintosh blade.

    Other: Tracheal intubation

  • Group 2 (V-MAC Group)

    Group 2 included patients that underwent endotracheal intubation using a V-MAC (Besdata, China) videolaryngoscope and Magill forceps.

    Other: Tracheal intubation

  • Group 3 (FFEI group)

    Group 3 included patients that underwent flexible fiberoptic endotracheal intubation (FFEI Group, Storz, Germany).

    Other: Tracheal intubation

Interventions

  • OtherTracheal intubation

    Video-assisted intubation technique

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What researchers measure

Primary outcomes

  1. Comparison of three video laryngoscopes: Rigid telescopes, C-MAC, flexible bronchoscopy for intubation in patients with anticipated difficult airways

    Successful intubation at first attempt

    Time frame: 1 day

  2. Comparison of three video laryngoscopes: Rigid telescopes, C-MAC, flexible

    Intubation time (sec)

    Time frame: 1 day

Secondary outcomes

  1. Comparison of three video laryngoscopes: Rigid telescopes, C-MAC, flexible

    Labial mucosa injury, Dental injury, Oral and pharyngeal mucosal injury, Vocal cord or lesion injury,

    Time frame: 1 day

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Study locations

1 site
  • Yaser Said Cetin
    Van, 65080, Turkey
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References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05187052
Lead sponsor
Yuzuncu Yıl University
Responsible party
Yaser Said Cetin (MD, Yuzuncu Yıl University) — Principal investigator
First posted
Jan 11, 2022
Start date
Feb 1, 2020
Primary completion
Sep 1, 2021
Completion
Sep 1, 2021
Last update
Jan 11, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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