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

Completed

• Conditions: Videolaryngoscopy
• Interventions: Other: Tracheal intubation

• Registration Number: NCT05187052
• Lead Sponsor: Yuzuncu Yıl University

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.

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.

Study Timeline

• Study Start: 2020-02-01
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01
• Study First Submitted: 2021-11-15
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-23
• Last Update Submitted: 2021-12-23
• Study First Posted: 2022-01-11
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2 (V-MAC Group)	Tracheal intubation	Group 2 included patients that underwent endotracheal intubation using a V-MAC (Besdata, China) videolaryngoscope and Magill forceps.
Group 1 (REI group)	Tracheal intubation	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.
Group 3 (FFEI group)	Tracheal intubation	Group 3 included patients that underwent flexible fiberoptic endotracheal intubation (FFEI Group, Storz, Germany).

Primary Outcome Measures

Name	Time	Method
Comparison of three video laryngoscopes: Rigid telescopes, C-MAC, flexible bronchoscopy for intubation in patients with anticipated difficult airways	1 day	Successful intubation at first attempt
Comparison of three video laryngoscopes: Rigid telescopes, C-MAC, flexible	1 day	Intubation time (sec)

Secondary Outcome Measures

Name	Time	Method
Comparison of three video laryngoscopes: Rigid telescopes, C-MAC, flexible	1 day	Labial mucosa injury, Dental injury, Oral and pharyngeal mucosal injury, Vocal cord or lesion injury,

Trial Locations

Locations (1)

Yaser Said Cetin; 🇹🇷 Van, Turkey