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

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.

Study Overview

• Status: Completed
• Conditions: Videolaryngoscopy
• Intervention / Treatment: Other: Tracheal 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 Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Turkey
  • Van, Turkey, 65080
    • Yaser Said Cetin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Video-assisted intubation technique
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; Video-assisted intubation technique
Group 3 (FFEI group); Group 3 included patients that underwent flexible fiberoptic endotracheal intubation (FFEI Group, Storz, Germany).	Other: Tracheal intubation; Video-assisted intubation technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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,	1 day

Collaborators and Investigators

• Sponsor: Yuzuncu Yıl University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: November 15, 2021
• First Submitted That Met QC Criteria: December 23, 2021
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 23, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Airway management, Difficult airway, Tracheal intubation
• Other Study ID Numbers: VBEAK 2020/12-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No