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

NCT05187052 | Completed DMC

• 1 other identifier: VBEAK 2020/12-02
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Videolaryngoscopy

Keywords

Airway management, Difficult airway, Tracheal intubation

Outcome Measures

Primary Outcomes (2)

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

  Successful intubation at first attempt

  1 day

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

  Intubation time (sec)

  1 day

Secondary Outcomes (1)

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

  1 day

Study Arms (3)

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

Tracheal intubation OTHER

Video-assisted intubation technique

Group 1 (REI group); Group 2 (V-MAC Group); Group 3 (FFEI group)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Yaser Said Cetin

Van, 65080, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: January 11, 2022
• Study Start: February 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: January 11, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)