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

Videolaryngoscopy Clinical Trial

— Rigidscopes  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05187052
• Other study ID #: VBEAK 2020/12-02
• Status: Completed
• Start date: February 1, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: December 2021
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Videolaryngoscopy

Intervention

Other:
• Tracheal intubation
Video-assisted intubation technique

Locations

Country	Name	City	State
Turkey	Yaser Said Cetin	Van

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Comparison of three video laryngoscopes: Rigid telescopes, C-MAC, flexible	Intubation time (sec)	1 day
Secondary	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