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

Sponsor

Yuzuncu Yıl University (Other)

Overall Status

Completed

CT.gov ID

NCT05187052

Collaborator

(none)

150

Enrollment

Location

Actual Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Videolaryngoscopy	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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

150 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2020

Actual Primary Completion Date :

Sep 1, 2021

Actual Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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,

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yaser Said Cetin	Van		Turkey	65080

Sponsors and Collaborators

Yuzuncu Yıl University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yaser Said Cetin, MD, Yuzuncu Yıl University

ClinicalTrials.gov Identifier:

NCT05187052

Other Study ID Numbers:

VBEAK 2020/12-02

First Posted:

Jan 11, 2022

Last Update Posted:

Jan 11, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yaser Said Cetin, MD, Yuzuncu Yıl University

Airway management, Difficult airway, Tracheal intubation

Study Results

No Results Posted as of Jan 11, 2022